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FOOD & DRUG ADMINISTRATION

DEPARTMENT OF HEALTH AND HUMAN SERVICES

HOMEOPATHIC PRODUCT REGULATION:

EVALUATING THE FOOD AND DRUG ADMINISTRATION'S

REGULATORY FRAMEWORK AFTER A QUARTER CENTURY

April 21, 2015

Location:

The Great Room

White Oak Campus

10903 New Hampshire Avenue

Silver Spring, MD 20993

Reported by: Natalia Thomas Capital Reporting Company



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1 M E E T I N G R O S T E R

2 PRESIDING OFFICER:John J. Whyte, M.D., M.P.H.

3 Director, Professional Affairs and StakeholderEngagement Center for Drug Evaluation and Research

4PANEL MEMBERS

5Kate Bent, R.N., Ph.D.

6 Assistant Commissioner for Compliance Policy,Director, Office of Policy and Risk Management,

7 Office of Regulatory Affairs

8 Rima Izem, Ph.D.Lead Mathematical Statistician,

9 Division of Biometrics VII, Office ofBiostatistics, Office of Translational Sciences,

10 Center for Drug Evaluation and Research

11 Elaine LIPPMANN, J.D.Regulatory Counsel, Office of Regulatory Policy,

12 Center for Drug Evaluation and Research

13 Richard (Rik) Lostritto, Ph.D.Director, Division of Internal Policies and

14 Procedures, Office of Pharmaceutical Policy,Office of Pharmaceutical Quality, Center for Drug

15 Evaluation and Research

16 Theresa Michele, M.D.Director, Division of Nonprescription Drug

17 Products, Office of New Drugs, Center for DrugEvaluation and Research

18Judy McMeekin, Pharm.D.

19 Director, Medical Products and Tobacco PolicyStaff, Office of Policy and Risk Management,

20 Office of Regulatory Affairs

21 Robert 'Skip' Nelson, M.D., M.Div., Ph.D.Deputy Director and Senior Pediatric Ethicist,

22 Office of Pediatric TherapeuticsOffice of theCommissioner



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1 M E E T I N G R O S T E R(continued)

2Brad Pace, J.D.

3 Supervisory Regulatory CounselOffice of Compliance, Center for Drug Evaluation

4 and Research

5 Charles G. Wu, Ph.D.Pharmacognosy and Pharmacology Reviewer Office of

6 Pharmaceutical Quality Center for Drug Evaluationand Research

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1 T A B L E O F C O N T E N T S

2 AGENDA ITEM PAGE

3 Presiding Officer Remarks 6 John Whyte, Director, PASE, CDER, FDA

4Robert C. Dumont 11

5 Raby Institute for Integrative Medicine At Northwestern, LLC

6Karl Robinson 27

7Paul Mittman 43

8 Southwest College of Naturopathic Medicine and Health Science

9Will Woodlee 57

10 American Herbal Products Association

11 Youngran Chung 70 Northwestern University Feinberg School of

12 Medicine, Ann & Robert H. Lurie Children's Hospital of Chicago

13Ronald Boyer 82

14 Center for Education and Development of Clinical Homeopathy

15J.P. Borneman 98, 113

16Gary Yingling 102

17Todd Hoover 108

18 Homeopathic Pharmacopoeia Convention of the United States

19Al Lorman 129

20 Law Office of Alvin J. Lorman

21Terry Cotter 144

22 Terra-Medica Inc.



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1 T A B L E O F C O N T E N T S(continued)

2AGENDA ITEM PAGE

3Edward D. Pergament 153

4 Materia Medica Holding

5 Ronald D. Whitmont 168

6 Bernardo Merizalde 172

7 David Riley 178

8 Michelle Dossett 183 American Institute of Homeopathy

9David Chipkin 202

10 Parmesh Banerji Life Sciences, LLC

11 Yale Martin 213

12 Patrick Gibbons 225 Emerson Healthcare Group

13Gary Kracoff 233

14 Johnson Compounding and Wellness Center

15 Peter Fisher 246 Royal London Hospital for Integrated Medicine

16Daniel L. Michels 261

17Closing Remarks 276

18 John Whyte, Director, PASE, CDER, FDA

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1 P R O C E E D I N G S

2 Presiding Officer Remarks:

3 DR. WHYTE: Well good morning, everyone.

4 I want to welcome back those folks that are here

5 for their second day of the Homeopathic Product

6 Regulation: Evaluating the Food and

7 Drug Administration's Regulatory Framework After a

8 Quarter-Century, Part 15 Hearing.

9 And for those of you that this is their

10 first day, welcome to the FDA. I'm Dr. John

11 Whyte. I'm the director of the professional

12 affairs and stakeholder engagement group here at

13 the Center for Drug Evaluation and Research, and I

14 will serve as the presiding officer of this

15 hearing and will also be the moderator today.

16 A few housekeeping notes. I do want to

17 remind people, those that were here yesterday may

18 remember, during the breaks there'll be a kiosk

19 where you can order lunch, so it is always a good

20 idea to pre-order your lunch, because you won't be

21 able to go to the FDA cafeteria.

22 This meeting is also being webcast and



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1 I'll provide that web link in a few minutes when I

2 get it again. But the public hearing today will

3 allow the FDA to obtain information about the

4 FDA's regulatory framework for drug products

5 labelled as homeopathic, in an effort to better

6 promote and protect the public health, including

7 by insuring that consumers and patients have the

8 necessary information to make informed choices

9 about products labelled as homeopathic.

10 And this is Rea Blakey who's been

11 helping us today, so thank you Rea. Rea used to

12 be at Channel 7 for a long time. Any good remarks

13 I have are due to Rea. So the website that you

14 can watch online or refer to your friends is

15 collaboration.fda.gov/hprapril2015.

16 Again,

17 collaboration.fda.gov/hprapril2015. And in

18 response to someone's question earlier today,

19 there is no hash tag to report, for those of you

20 that are on Twitter. We don't -- I don't think we

21 really do that here, but you all can do what you

22 want, but we don't have any official hash tags.



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1 And for those of you that don't know what I mean

2 about a hash tag, don't worry about it.

3 So again, by providing feedback to the

4 questions that we listed in the federal register

5 notice, that really will allow us, through your

6 oral testimony, as well as any written comments,

7 to help us think through our regulatory framework.

8 I do want to mention again that the

9 public hearing will be held in accordance with

10 Part 15, that is 21 CFR Part 15. The hearing is

11 informal and the rules of evidence do not apply.

12 I ask that no participant interrupt any other

13 participant and we didn't have any problems with

14 that yesterday and I don't foresee any problem

15 today, so thank you for that.

16 Only the presiding officer and the

17 members of the panel can actually ask questions.

18 So before I go into some additional remarks, I

19 want the panel to have an opportunity to introduce

20 themselves. For those that were here yesterday,

21 you'll recognize a new face, but we'll start

22 closest to me with Rima.



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1 DR. IZEM: Hello, good morning. This is

2 Dr. Rima Izem. I'm a team leader in the Office of

3 Biostatistics.

4 MS. LIPPMANN: Good morning. I'm Elaine

5 LIPPMANN, Regulatory Counsel in the Office of

6 Regulatory Policy in CDER.

7 DR. LOSTRITTO: Good morning. Rik

8 Lostritto. I'm a division director in the Office

9 of Policy for Pharmaceutical Quality and also

10 acting associate director for science in that

11 office.

12 DR. MCMEEKIN: Good morning. My name is

13 Judy McMeekin. I'm the director for medical

14 products and tobacco policy staff in the Office of

15 Regulatory Affairs.

16 DR. MICHELE: Good morning. I'm Dr.

17 Theresa Michele. I'm the division director of

18 Non- Prescription Drug Products in the Office of

19 New Drugs at CDER.

20 DR. NELSON: I'm Dr. Robert Nelson. I'm

21 the deputy director of the Office of Pediatric

22 Therapeutics in the Office of the Commissioner.



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1 MR. PACE: Hi. I'm Brad Pace. I'm a

2 regulatory counsel in the CDER Office of

3 Compliance.

4 DR. WU: Good morning. My name is

5 Charles Wu from Botanical Review Team, Office of

6 Pharmaceutical Quality.

7 DR. WHYTE: I also just want to

8 introduce again our official timekeeper, Dave

9 Boggs. And then Immo Zadezensky who will help if

10 we have any issues with slides. So again, if

11 folks feel they didn't get an opportunity to make

12 all of their comments today or they think of

13 something later, you know I do want to remind

14 people that people still can submit comments.

15 You can do it either electronically and

16 the website is listed up there. You can be old

17 school and write a note to us and that's where you

18 would send it to. I caution you that you have

19 until June 22 to actually send those comments.

20 So if for some reason you didn't get to

21 say everything that you would have like to today,

22 you still have an opportunity to send comments



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1 either electronically or written.

2 Some of you may remember from yesterday,

3 I noted that the meeting will be transcribed. We

4 have our transcriptionist and it will be posted on

5 the FDA's meeting page within 45 days of this

6 meeting.

7 All right. With that, we will then

8 start with our first speaker and that is Robert

9 Dumont, from the Raby Institute for Integrative

10 Medicine at Northwestern, LLC. Robert C. Dumont

11 DR. DUMONT: Okay, I want to make sure

12 the microphone is okay. I'm not too loud, not too

13 soft. Okay? Right. My name is Robert C. Dumont.

14 I am a certified pediatrician, practicing at the

15 Raby Institute for Integrative Medicine in

16 Chicago. I have no financial relationship,

17 however I will say that the trade organization is

18 paying for my board and travel expenses for here.

19 Again, as I said, I'm a certified

20 pediatrician practicing in Chicago. The Raby

21 Institute for Integrative Medicine is a private

22 practice group. We have six practicing



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1 integrative medicine physicians there.

2 Previously, I had been assistant

3 professor at the Ohio State University, Nationwide

4 Children's Hospital as it's known now, and then

5 moved on to associate professor at Loyola

6 University in Chicago.

7 There, I was director of the Pediatric

8 Integrative Medicine Program, along with Pediatric

9 Nutrition, and for a period of five years, I was

10 director of the Pediatric Cystic Fibrosis Center

11 there. So I'm fairly well-versed in conventional

12 medicine.

13 My background in integrative medicine

14 includes mind, body medicine training at the

15 Harvard Medical School, Herbert Benson's program

16 there, as well as hypnosis, (inaudible) medical

17 hypnosis. I'm boarded in medical acupuncture, and

18 I'm also boarded in the new board certification of

19 integrative medicine.

20 For those of you who are not familiar

21 with this, this is a brand new board under the

22 auspices of the American Board of Physician



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1 Specialties. So I have a broad range and a view

2 in terms of all aspects of integrative medicine.

3 Now my formal training in homeopathy was

4 through a program through the American Institute

5 of Homeopathy, and then through a teaching

6 organization, The Center for Education and

7 Development of Clinical Homeopathy.

8 This is a worldwide teaching

9 organization, physician-based, teaching over 20

10 countries. Since 2008, I have been a teacher

11 there and we teach in approximately six cities

12 across United States, and again, like I say, this

13 is a worldwide organization.

14 I've also published in the area of

15 integrative medicine; a pediatric review in

16 Pediatric Pulmonology, several chapters in

17 complementary alternative medicine, as well as a

18 chapter on clinical homeopathy in an upcoming

19 textbook.

20 Now, as to my role of homeopathy in my

21 practice. As a in integrative medicine

22 practitioner, my emphasis has always been



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1 primarily to educate patients with the established

2 improved diet and lifestyle and I think most

3 people who practice integrative medicine or

4 something of that sort, this is a primary goal to

5 correct people's lifestyle and such.

6 I also include other interventions.

7 Again, as I mentioned, it might be

8 pharmaceuticals, it might be mind/body

9 interventions, hypnosis, acupuncture. But as I

10 have gained more and more experience at

11 homeopathy, it has become a -- it'd been playing a

12 major role in my practice. It has proved to

13 exceptionally versatile and efficacious for many

14 medical problems, both simple and more complex.

15 And I would say now that nearly 80 percent of all

16 the patients who walk into my office come out with

17 a homeopathy medicine as part of their regimen.

18 Again, as I said, they've played a

19 valuable role in my practice and they've been

20 exceptionally helpful for my patients. An

21 important component that I've always liked about

22 homeopathy is its feature of safety and lack of



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1 drug interactions. So if they're on a plethora of

2 other medications, I feel safe to put them on

3 homeopathic medication as opposed to some other

4 herbal or supplement intervention.

5 And particularly so for the younger

6 children that I see, two year olds and such like

7 this. To me, the FDA regulations guided by the

8 HPCUS is an important and reassuring aspect to

9 that. Now I wanted to respond to three of the

10 questions.

11 First question, what are consumers and

12 healthcare provider attitudes towards human drug

13 and biological products labeled as homeopathic?

14 I've -- again, I see a lot of patients and

15 certainly talk to people on the street, and I've

16 given over 100 presentations, invited

17 presentations, mostly to physicians, but also I've

18 given them to organizations, Turner's Syndrome,

19 organizations such like this, so I have a good ear

20 to what people are thinking out there and their

21 views.

22 So a few people who consult me in my



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1 office, consult me specifically because I use

2 homeopathy in my practice. They have knowledge of

3 it. They've used it previously, and they prefer

4 it over other interventions. However, the

5 majority of patients -- and of course, their

6 parents, as I do primarily pediatrics -- that I

7 encounter have no real understanding of what

8 homeopathy is an often confuse it with herbal

9 medicines.

10 So a big part of my visit is explaining

11 what homeopathy is. They also go home with a nice

12 handout, because as we know, whether it's in a

13 talk or whether it's in an office, most people

14 walk out with 10 percent of the information that

15 you present. And so I like them to go home with

16 something to explain it a little more so they can

17 review it a little more fully.

18 Anyways, once it's explained, the great

19 majority of people are very open to it. I can

20 only remember maybe in the past 20 years, one or

21 two people who did not want to try homeopathic

22 medicines. And the majority of them receive good



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1 to in fact, excellent results. Some of them are

2 so pleasantly surprised at the results and

3 actually amazed.

4 And as they begin to understand it more

5 and again, like I say, send the information on it,

6 they begin to use it more on their own for acute

7 self- limiting issues, although very often in

8 beginning they'll call me and say, Oh, I have such

9 and such issue; what can I use?

10 And then they all obviously come back

11 with something with more complex chronic problems

12 to me for their issues. My interaction with

13 conventionally- trained medical practitioners,

14 which is either through one-to-one contact or

15 through lectures usually given grand rounds, also

16 reveal sort of a lack of knowledge of homeopathy

17 in the more conventionally trained physicians.

18 Again, this is with its basic

19 principles, how we understand it seems to work,

20 safety issues, and also the supportive evidence.

21 Once it's explained, most of them, the majority of

22 them, are very accepting of it. It's especially



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1 true for the younger practitioners I find;

2 certainly the residents, medical students, and the

3 newly minted attendings as they come out.

4 I've even prescribed homeopathic

5 medicines in the hospital even for premature

6 infants. Record it in the chart and very

7 accepting of the attending physicians, managing

8 physicians of those patients. So like I say, it's

9 not just, Yes, we accept it in the group, but when

10 I've actually used it in the hospital, people

11 quite accepting of it.

12 Question two: What data sources can be

13 identified or shared with FDA so that the Agency

14 can better assess the risks and benefits of

15 homeopathic drug products?

16 I think the primary source would be the

17 HPCUS. This organization is responsible for

18 establishing standards for manufacturing with

19 regards to safety and development of monographs

20 with respect to the indications. Other adjunct

21 sources would include the American Association of

22 Homeopathic Pharmacists, the American Institute of



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1 Homeopathy, and the organization that I mentioned

2 earlier, the Center of Education & Development of

3 Clinical Homeopathy.

4 These organizations consists of

5 pharmacists and medical practitioners who practice

6 and are versed in everyday use of homeopathic

7 medicines, and again, would serve as a wonderful

8 adjunct source.

9 Now question eight: Do consumers and

10 healthcare providers have adequate information to

11 make informed decisions about drug products

12 labeled as homeopathic? And this is probably the

13 main question people are looking at.

14 I think an increasing number of

15 healthcare practitioners are becoming more aware

16 and therefore more open to what's used by their

17 patient. However, the majority of healthcare

18 practitioners still have little understanding of

19 homeopathy, and sometimes with misperceptions,

20 again much like the consumers confusing with

21 herbs.

22 And so there needs to be more education



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1 hopefully through hospitals, whether an

2 integrative medicine program or maybe through

3 grand rounds and such, like just to introduce them

4 to the topic, which I have done and we've spoken

5 to the Cystic Fibrosis conferences, AAP

6 organizations, and we're always trying to get into

7 some organization to explain what homeopathy is.

8 For the consumer, homeopathy has a

9 definite place for symptomatic, self-treatment of

10 limited acute illnesses. And of course, I stress

11 "limited, acute illnesses". As we treat with

12 coughs, colds, sprains, and such like this with

13 any other over the counter medication.

14 They should be labeled as such, along

15 with the cautions, again, to see healthcare

16 professionals should there be some unusual change

17 or should the condition or problem persist over a

18 designated period of days, depending upon the

19 problem. And so therefore and sometimes the

20 labeling should not be changed.

21 I did check -- after a time we don't

22 necessarily look at these. We sort of glaze over



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1 them, but before I came here, several days ago I

2 looked at several products, and I found the

3 labeling to be more than adequate and informative

4 for a person's need.

5 Now obviously, that doesn't mean the

6 person's going to understand what homeopathy is,

7 but I think those people motivated will certainly

8 try to seek more information online or whatever.

9 Now whether or not -- and I know this question

10 might come up, we should, on the labels, put some

11 reference as to where they can go for appropriate

12 information might be something to consider. And I

13 thank you very much.

14 DR. WHYTE: Thank you, Dr. Dumont. I

15 like how you anticipated questions ahead of time,

16 but let's see if the panelists have any questions.

17 We'll have five minutes with questions and we'll

18 start closest to the podium.

19 DR. LOSTRITTO: Thank you. In the last

20 section of your talk, you mentioned enforcement

21 regarding labeling. Other than the references you

22 just mentioned as possibly being put in the



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1 labeling, what one top situation today that you

2 see that exists, that you would address via

3 enforcement that you mentioned here and how would

4 you do that? What would you recommend?

5 DR. DUMONT: I think one of the concerns

6 and I've spoken to this with my wife, is when

7 there is labeling for a chronic condition.

8 Acuteless (sic), self-limiting conditions, yes;

9 but a chronic condition or something that would

10 lead you to a chronic condition would be probably

11 my main concern.

12 DR. MICHELE: Thank you for your

13 presentation. I have questions in two areas. One

14 I'll start off with, you spoke a lot about

15 administering this to patients in the hospital and

16 then you followed up by saying that these

17 homeopathic products are primarily for consumers

18 to use for self-limited, short-term illnesses. So

19 I was wondering if you could elaborate a bit about

20 what in-patient conditions you're treating with

21 homeopathy.

22 DR. DUMONT: Well, as I'm trained in



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1 homeopathy, I can treat more complex conditions.

2 I mean I can give you an example. As head of the

3 pediatric nutrition program there, I was consulted

4 for someone who was undergoing chemotherapy and

5 every time she was in a hospital, she was vomiting

6 -- nausea, vomiting, and losing weight, and

7 basically they wanted a PICC line for parental

8 nutrition.

9 And what I had suggested, hearing her

10 story, was let's try something else, because

11 there's some dangers pairing (ph) a PICC line in

12 there. And I said, Let's try homeopathic

13 medicine. I know this medicine was mentioned

14 yesterday, cholchicum. And we put her on that I

15 think the night before the morning of, and then as

16 she needed it through that, and I will say the

17 next time she came in for chemotherapy she was

18 eating pizza. Much better.

19 And I've used it for various other

20 issues. But again, that's under my direction as

21 someone who is a physician trained in homeopathic

22 medicine.



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1 DR. MICHELE: Thank you. And then the

2 other area, you mentioned that one of the

3 advantages of homeopathic medicines is that they

4 do not have drug/drug interactions. So I was

5 wondering if you could tell us about whether

6 homeopathic agents are tested for drug/drug

7 interactions, and if so, if you could point us to

8 the data that support that.

9 DR. DUMONT: I could not -- this is not

10 my area of expertise, but this is -- when you

11 consider the dilutions that I use would be 9C,

12 12C, and 30C. So the amount of -- number of

13 molecules in there would be minuscule and once you

14 go past 12C, you're again, past Avogadro's number.

15 So there'd be nothing in there to interact. So

16 based on those principles. Now this would not

17 necessarily be true with a 1X or 2X, and I would

18 be very cautious with those.

19 DR. MICHELE: Thank you.

20 DR. NELSON: I'm going to ask you as

21 well to elaborate on the in-hospital use and

22 specifically I'm curious about the situation in



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1 the neonatal intensive care unit that you

2 mentioned in your talk.

3 DR. DUMONT: Yeah. Let's see. I'm

4 trying to think of the instances -- I've used

5 actually is acupuncture and homeopathy. I didn't

6 want to confuse things. Now when I would be

7 consulted in there, usually for a particularly

8 irritable child or something like this that they

9 can't figure out, very often it's usually due to a

10 formula or dairy intolerance.

11 But nonetheless, I simply use the

12 homeopathic medicines. Again, I use the higher

13 dilutions, 9 or 12C. I dilute them in water and

14 they basically -- the nurses will squirt in the

15 mouth several times a day. Again, I feel safe

16 using these more so than if I were going to use an

17 herbal medication or a supplement. And I

18 certainly feel much safer than a pharmaceutical

19 drug that can have side effects.

20 MR. PACE: At risk of sounding like a

21 broken record, I know a lot of people have

22 discussed consumer choice for these types of



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1 products and that's why I think we're so concerned

2 about consumers having an informed choice.

3 You seem to emphasize how necessary it

4 is for you to explain to people in your practice

5 what homeopathy is. Yet you say that consumers

6 are adequately informed from an OTC perspective.

7 So I was curious to know how, kind of, those fit

8 together?

9 DR. DUMONT: Okay. Well, if you

10 consider all pharmaceuticals out there,

11 supplements and herbs, in fact they probably have

12 as little information or knowledge of those as

13 they do with homeopathic medicines. Now if we're

14 going to choose between, I would -- just my

15 knowledge of homeopathy, I find that much safer,

16 again with the higher dilutions.

17 MR. PACE: Right. I think the big

18 difference there is with respect to other

19 pharmaceuticals. Those do go through some sort of

20 FDA analysis --

21 DR. DUMONT: Yes.

22 MR. PACE: -- whereas these others have



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1 a policy in which we don't look at them premarket.

2 DR. DUMONT: But again, with regards to

3 certain specific dilutions, the safety profile for

4 homeopathy medicines has been shown -- and of

5 course we saw yesterday with the Poison Control

6 Center, that it's a very safe form of medicine.

7 So if I were going to have a consumer go through

8 whole foods or someplace and choose something for

9 a specific set of symptoms, I'd feel much safer

10 for them to choose a homeopathic medicine based on

11 its inherent lack of pharmaceutical interaction or

12 effects.

13 MR\. PACE: Thank you, doctor.

14 DR. DUMONT: Thank you.

15 DR. WHYTE: All right. At this time,

16 I'd like to welcome Karl Robinson to the podium.

17 Karl Robinson

18 DR. ROBINSON: Thank you. I'm a medical

19 doctor from Houston in the continuous practice of

20 classical homeopathy for 39 years. And I'm the

21 author of a book on homeopathy called, "Small

22 Doses, Big



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1 Results: How Homeopathic Medicine

2 Offers Hope in Chronic Disease."

3 For the last 12 to 15 years, I've been

4 teaching homeopathy in Latin America, Cuba,

5 Honduras, Guatemala, El Salvador, and yes, those

6 three. So I'm here representing the Texas Society

7 of Homeopathy, which I cofounded about 21 years

8 ago. I'm also a member of the American Institute

9 of Homeopathy.

10 I would like to suggest that homeopathic

11 medicines are currently utilized in three ways and

12 then segue into the question of labeling. Level

13 one, people who know very little about homeopathy

14 use it in a very specific manner. They give say,

15 Arnica montana for tissue trauma, bruises;

16 Symphytum to speed bone healing; Belladonna for

17 any and all fevers; or they buy a homeopathic

18 mixture containing a number of homeopathic

19 medicines with a general label saying allergy or

20 headache or diarrhea or fever and so on. We

21 sometimes call this type of prescribing, "this for

22 that".



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1 Level two: Acute prescribing. The

2 person starts to study homeopathy and with the use

3 of a book or two, learns how to treat simple,

4 self-limiting illnesses. They use a single

5 homeopathic medicine. Nancy Peplinsky, of Holistic

6 Moms Network did that when she successfully

7 treated her children and avoiding using

8 antibiotics. Such people become fascinated with

9 homeopathy and prefer to use single medicines

10 rather than mixtures.

11 Level three: Using a single homeopathic

12 medicine and taking into account not only the

13 chief complaint, but a panoply of mental,

14 emotional, and physical factors, one attempts to

15 treat multiple problems all at once. This kind of

16 homeopathy is what Samuel Hahnemann, the founder,

17 expounded in his seminal work, "The Organon of

18 Medicine".

19 We called this way of prescribing

20 classical homeopathy. It is what I and my

21 colleagues from the American Institute of

22 Homeopathy, the North American Society of



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1 Homeopaths, and the naturopathic physicians

2 practice. We attempt, with varying degrees of

3 success, to halt, perhaps cure a chronic disease

4 that can only be palliated or managed by

5 conventional pharmacological products.

6 We don't do level one homeopathy. We

7 don't use mixtures and we don't recommend our

8 patients use them either, but we're not against

9 them. Level one is gateway homeopathy and we hope

10 more and more users will move up into single

11 medicine classical homeopathy. When one uses

12 mixtures, one is using the shotgun approach,

13 hoping one or more of the ingredients will give

14 some relief.

15 The classical approach uses a silver

16 bullet; one medicine designed to bring about a

17 radical transformation in the organism. Level one

18 homeopathy is big and growing and is mostly what

19 this hearing is about.

20 Now about labeling. In a typical

21 proving done by Hahnemann, there were often more

22 than 2,000 symptoms recorded and these were



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1 recorded not in a word or two, but in complete

2 sentences. Two centuries later, some of these

3 same medicines now have many thousands of symptoms

4 in their pathogenesis. In the repertory, which is

5 a book like a huge dictionary or concordance, in

6 the repertory I use, there are 16,800 symptoms

7 attributable to homeopathic sulphur.

8 The idea of compacting that kind of data

9 into one or two or at most three words to put on a

10 label, well frankly, it makes little sense to me

11 and it misleads the consumer. I would propose the

12 FDA consider removing labels indicating usage from

13 all single medicines, simply because the present

14 labeling system makes no sense.

15 At the same time, the FDA might consider

16 more extensive labeling of OTC homeopathic

17 mixtures, even to the extent of a package insert

18 suggesting that this product is no substitute for

19 conventional medical treatment and must be used

20 with caution.

21 Now to comment briefly on two points.

22 The first, the FDA has asked about the consumer



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1 and healthcare provider attitudes toward products

2 labeled homeopathic. Virtually all speakers have

3 mentioned that, and I'm not going to dwell on it.

4 The point that -- the fact that the sales of

5 homeopathic products are surging, suggests that

6 the consumer is voting with his pocketbook.

7 The question is why? So some answers

8 that I can provide. Daily, I hear patients say of

9 their ailment, I've had this for a long time.

10 I've been taking the prescribed medicines for

11 months and still I'm not getting better. Now I'm

12 having side effects. Can homeopathy help?

13 Another says, I've been to one doctor

14 after another. One specialist after another,

15 nobody knows what's wrong with me. Do you think

16 homeopathy can help?

17 Someone else says, They tell me my

18 condition is incurable, that'll I'll have to stay

19 on this medicine for the rest of my life. I don't

20 want to believe that. Can homeopathy help?

21 It's very simple. Sick people want to

22 get well to feel better, and despite undergoing



33

1 extensive testing and faithfully taking their

2 prescribed medicines, they don't feel well. So

3 they're turning to acupuncture, biological

4 products, homeopathy, and other modalities. In a

5 free society such as ours, I would say this

6 freedom of choice is a good thing with the caveat

7 that the products do no harm.

8 Next point. The FDA wants to know, do

9 consumers and healthcare providers have adequate

10 information to make informed decisions about drug

11 products labeled homeopathic. The cynical part of

12 me wants to say probably not. I know when I treat

13 myself, I am reminded of the great Sir William

14 Osler who said, "The physician who treats himself

15 has a fool for a patient".

16 However, the truth is everyone self-

17 diagnoses and self-treats. It's part of being

18 human. I have a headache, I have arthritis, I'm

19 depressed, and so on and so forth. With the

20 advent of the Internet there is more medical

21 information available, both reliable and useless,

22 than at any time in human history.



34

1 Millions of people are using the

2 Internet every day to learn more about what ails

3 them, looking not only for a diagnosis, but

4 alternative ways to treat themselves. Whether the

5 consumer can self-treat reliably and effectively

6 is another matter.

7 Our panelist, Dr. Michele, posted on the

8 FDA website her criteria for the OTC products.

9 She stated that these were her views and not

10 necessarily those of the Agency. She wrote that

11 these products "Can be adequately labeled such

12 that the consumer can self-diagnose, self-treat,

13 and self-manage the condition being treated. No

14 health practitioner is needed for the safe and

15 effect use of the product." "Drug has low

16 potential for misuse and abuse." "The safety

17 margin is such that the benefits of OTC

18 availability outweigh the risks."

19 Can homeopathic products be labeled in

20 such a way as to aid in self-diagnosis and self-

21 treatment? I would say yes. The crucial part of

22 Dr. Michele's schema is that the "drug has low



35

1 potential for misuse and abuse". In the case of

2 OTC homeopathic products, such potential is

3 virtually nil and the "safety margin is such that

4 the benefits of OTC availability outweigh the

5 risks".

6 A word about OTC non-steroidal anti-

7 inflammatory drugs. Perhaps the best known OTC

8 drug in the world is Aspirin, followed closely by

9 other non-steroidal anti-inflammatory drugs.

10 These drugs are dangerous. In an article

11 published in American Family Medicine, March 1,

12 2012, it was reported that there were over 400,000

13 hospital admissions per year in the United States

14 because of gastrointestinal bleeding.

15 The authors state, "It --

16 gastrointestinal bleeding has been associated with

17 increasing non-steroidal anti-inflammatory drug

18 use". No homeopathic medicine is remotely as

19 dangerous as Aspirin and other non-steroidal anti-

20 inflammatory drugs. Until the FDA has compelling

21 evidence that OTC homeopathic products are

22 harmful, they should continue to be as widely



36

1 available as are OTC pharmaceuticals. As I

2 suggested earlier, the homeopathic mixtures

3 probably should have more comprehensive labeling.

4 Chronic disease is merciless and

5 relentless and to cure it requires the best of all

6 schools of medicine. The medicine of the future

7 will be an astute melange using technology and

8 chemistry to diagnose with patients having the

9 opportunity to choose treatment from among several

10 well-developed schools of medicine: conventional

11 or allopathic medicine, homeopathy, traditional

12 Chinese medicine, Ayurveda, and perhaps others.

13 In sum, I wish to emphasize that

14 homeopathic medicines are at least an order of

15 magnitude safer than conventional pharmaceutical

16 drugs, and in the hands of an expert prescriber

17 can be equally or more effective. Thank you.

18 DR. WHYTE: Thank you, Dr. Robinson for

19 your presentation. Thanks for your quote by Sir

20 William Osler, who actually was a comedian and

21 founded Johns Hopkins Hospital, not too far from

22 us. Since you mentioned Dr. Michele, let's start



37

1 with Dr. Michele and then we'll work from Dr.

2 Michele back towards the podium.

3 DR. MICHELE: Thank you so much for your

4 presentation. I just wanted to make sure that I

5 understood you correctly. You commented that you

6 recommend removing all indications from

7 homeopathic medications. And I was wondering if

8 you could elaborate a bit upon on that, and

9 further comment on if we were to pursue that path,

10 then how would the consumer choose amongst the

11 different homeopathic medications that are on the

12 market?

13 DR. ROBINSON: Well, as I mentioned, the

14 amount of information that's available for any one

15 homeopathic medicine, one single homeopathic

16 medicine is almost astronomical. So condensing

17 that on to a label makes it very, very -- well,

18 makes it virtually impossible. And whatever's put

19 on cannot really guide anyone.

20 Now before the FDA had this regulation,

21 homeopathic medicine simply had the name of the

22 medicine on it. I think that was changed in 1988



38

1 or something. So I appreciate your concern, but

2 by the very nature of homeopathic medicines, they

3 have so many uses that how to label them without

4 causing confusion, I simply don't know.

5 DR. MCMEEKIN: Thank you for you

6 presentation. You mentioned or suggested that

7 there should be some comprehensive labeling

8 changes. Can you provide two additional examples

9 of the labeling changes, outside taking the

10 indications off the label?

11 DR. ROBINSON: The homeopathic mixtures?

12 DR. MCMEEKIN: Uh-hm.

13 DR. ROBINSON: Could I provide what?

14 The --

15 DR. MCMEEKIN: Could you provide

16 additional examples of labeling changes that you

17 suggest?

18 DR. ROBINSON: Well, this is -- this

19 would be a very complicated issue and it would

20 require a trained homeopath to work in conjunction

21 with the FDA frankly. I mean each label would

22 have to be a little differently probably, but they



39

1 could certainly suggest that you shouldn't take

2 these medicines endlessly, that there might be

3 some untoward effects if you do that. Homeopathic

4 medicines usually are not intended to be taken

5 daily, daily, daily, one -- and then depending on

6 the medicine, that it's not a substitute for

7 conventional treatment and so forth.

8 DR. LOSTRITTO: Thank you for your

9 presentation. My question's also about the

10 labeling and a quick scan of homeopathic products

11 in say Whole Foods, you see some products in

12 multiple dilutions. In addition to the indication

13 problem, how would you, in labeling, instruct the

14 patient to choose the appropriate dilution?

15 DR. ROBINSON: The appropriate dilution?

16 DR. LOSTRITTO: They usually would

17 either go to the -- what's considered the most

18 potent, if they were going to (inaudible) one.

19 DR. ROBINSON: Well, if we're speaking

20 of a store such as whole foods, they only carry

21 30C usually, in my experience. So that's what's

22 available. And when I -- and I can't find -- I



40

1 just can't find stores that carry higher potencies

2 usually. So they get them from me.

3 DR. LOSTRITTO: So you don't see

4 dilution as an issue?

5 DR. ROBINSON: Pardon?

6 DR. LOSTRITTO: You don't see dilution

7 as an issue in labeling in terms of --

8 DR. ROBINSON: No, I think they should

9 just be labeled with it -- they have to be labeled

10 with a dilution. There's no question about that -

11 - whatever, 6C, 9C, 30C, 200, whatever. That's

12 absolute. You have to know what you're getting,

13 yeah.

14 MS. LIPPMANN: You talk a bit about

15 provings.

16 DR. ROBINSON: Yes.

17 MS. LIPPMANN: And obviously we do

18 things pretty differently at the FDA. What is it

19 about the scientific method for demonstrating

20 safety and efficacy through our approval process

21 that is inconsistent with homeopathy?

22 DR. ROBINSON: Well, it's a totally



41

1 different paradigm. As I understand it,

2 conventional drugs are first tested on animals;

3 then later on sick people. Ours are only treated

4 on healthy human beings. So it's a different

5 paradigm. And it's all based on the idea that

6 like cures like; the law of similars. And

7 conventional medicines are not based on that

8 premise. So it's like comparing apples and eggs.

9 It just doesn't compare very well.

10 MS. LIPPMANN: But what is the use of

11 randomized, placebo-controlled clinical trials?

12 Why is that not an option for homeopathic?

13 DR. ROBINSON: It is an option. It's

14 been done. Dr. Jonas mentioned a number

15 yesterday, but it's difficult. In general,

16 homeopathy is very much of an observational

17 science. We talk to a patient. I do, the first

18 time for an hour and a half, about all their

19 complaints and many other aspects.

20 We give a medicine and we follow them

21 up, again asking about many, many aspects in that

22 first interview. It's not a matter of you give



42

1 this medicine and the blood pressure goes down.

2 It's not -- doesn't work that way. There's more

3 of a global response to the homeopathic medicine,

4 which hopefully a number of problems will be begin

5 to resolve under the influence of the single

6 correct medicine.

7 MS. LIPPMANN: So do you think then that

8 traditional clinical trials would not demonstrate

9 efficacy?

10 DR. ROBINSON: No, there have been

11 trials that have demonstrated efficacy. But I'm

12 saying that the homeopathic paradigm doesn't lend

13 itself to that. It's been done, it can be done,

14 it's difficult. Especially when, if you -- give

15 you an example. Let's say you have five people

16 with infectious Hepatitis A. The homeopath might

17 very well, based on unusual symptomatology, accuse

18 -- accompanying each case, give five different

19 homeopathic medicines, all of which could work and

20 restore the patient to health in a short time.

21 So there's a difficulty. You see it's

22 an individual prescribing. It's not -- it's not



43

1 the -- it's a different paradigm. That's all.

2 DR. WHYTE: Thank you. All right. Now

3 we will hear from Dr. Paul Mittman, from the

4 Southwest College of Naturopathic Medicine and

5 Health Sciences. Dr. Mittman? Paul Mittman

6 DR. MITTMAN: Thank you, Dr. Whyte and

7 members of the panel. My name is Paul Mittman.

8 I'm president and CEO of Southwest College of

9 Naturopathic Medicine and Health Sciences or SCNM.

10 I serve on the board of the Association of

11 Accredited Naturopathic Medical Colleges, and have

12 served on the boards of the American Holistic

13 Medical Association, and the American Association

14 of Naturopathic Physicians.

15 I was the founding editor of the

16 journal, Simillimum, and worked on the editorial

17 staff of the New England Journal of Homeopathy. I

18 received my Doctor of Naturopathic Medicine degree

19 from National College of Naturopathic Medicine in

20 1985 and practiced for 25 years.

21 I taught homeopathy at the National

22 Center for Homeopathy and at SCNM. I also hold a



44

1 Doctor of Education degree from the University of

2 Pennsylvania. I have no financial relationships or

3 conflicts of interest to disclose.

4 I offer my testimony on current

5 enforcement policies through the lens of medical

6 and health sciences education. According to the

7 CDC nearly five million Americans use homeopathy

8 annually. To promote and protect public health, a

9 sound regulatory and enforcement framework must

10 exist in conjunction with pharmacies that produce

11 and sell consumer medicines, be they homeopathic

12 or allopathic; with institutions that train

13 physicians, pharmacists, and other providers; with

14 manufacturers that are bound by clear regulatory

15 guidelines and subject to enforcement action with

16 the Homeopathic Pharmacopeia of the United States

17 and with retailer and consumer literacy.

18 Looking at this through the lens of

19 medical and health science education, SCNM, like

20 all naturopathic medical schools, train students

21 to educate patients and the public on the

22 appropriate indications for over the counter



45

1 homeopathic drugs.

2 The Doctor of Naturopathic Medicine

3 degree at SCNM is a four year, first profession,

4 doctoral program, regionally accredited by the

5 Higher Learning Commission of the North Central

6 Association of Colleges and Schools, and

7 programmatically by the Council on Naturopathic

8 Medical Education, both recognized by the U.S.

9 Department of Education.

10 SCNM's 4,290-hour program focuses on the

11 basic sciences and preclinical medicine in years

12 one and two, and clinical training and

13 conventional and CAM therapies in the years three

14 and four, including over 1,500 hours of supervised

15 clinical training.

16 Naturopathic medical schools train

17 naturopathic doctors to serve as primary care

18 practitioners. In this role our graduates learn

19 to diagnose and treat, co-manage, or refer the

20 full range of well, acute, and chronic conditions.

21 To meet this challenge, our students draw upon and

22 utilize the current state of medical science



46

1 including conventional and complementary and

2 alternative therapies.

3 These include pharmacology, minor

4 surgery, clinical nutrition, mindfulness,

5 botanical medicine, osseous and soft tissue

6 manipulation, and homeopathy. At SCNM we train our

7 students that each patient needs to be treated

8 individually and that the exercise of sound

9 clinical judgment requires an understanding of the

10 condition, its cause, and the range of options

11 available to address the situation.

12 Though not the only modality taught at

13 SCNM, the practice of homeopathy represents one of

14 the core components of naturopathic practice.

15 Students study homeopathic drugs and their

16 limitations, ensuring that when patients seek

17 guidance, the naturopathic student and then

18 physician has the background to answer questions.

19 Thus, students studying at a

20 naturopathic medical school learn homeopathic

21 principles and practice, including the study of

22 homeopathic drug indications, homeopathic history



47

1 taking, case analysis, dosing, and case

2 management. Students also learn which and when

3 prescription and over the counter homeopathic

4 drugs are appropriate.

5 Homeopathy is one of the subject areas

6 on NPLEX, the Naturopathic Physicians Licensing

7 Examination, the nationalizing exam used

8 throughout North America. With this dedication to

9 the importance of understanding the science behind

10 homeopathic medicines for practitioners and

11 patients, SCNM is the first medical school in the

12 United States to offer a one-year residency

13 specializing in homeopathy.

14 We expect our graduates to be able to

15 make recommendations and provide quality medical

16 advice against the backdrop of medicines,

17 including OTC medications produced and marketed in

18 compliance with existing laws and regulatory

19 guidance. Our students learn that the FDA

20 Compliance Product Guide, combined with the

21 Homeopathic Pharmacopeia of the United States,

22 protects the public by establishing strict



48

1 criteria on the inclusion of OTC homeopathic

2 drugs, the manufacturer of homeopathic drugs, and

3 the acceptable marketing of indications for over

4 the counter homeopathic drugs.

5 When followed, these conditions limit

6 the risk of adverse events for four reasons. One,

7 the list of official homeopathic drugs is limited

8 to drugs that met inclusion criteria. Two, the

9 over the counter restriction for use in self-

10 limiting disease conditions amenable for self-

11 treatment means that consumers do not take OTC

12 homeopathic drugs for extended periods of time.

13 Three, legal standards of strength,

14 quality, purity, and packaging exist for the

15 homeopathic drug product within the package,

16 thereby excluding adulteration with other natural

17 products or even prescription drugs. And four,

18 the attenuated composition of homeopathic drugs

19 prepared according to the HPUS guidelines for

20 manufacturing homeopathic medicines, limits the

21 number and severity of adverse events and the

22 likelihood for allopathic homeopathic drug



49

1 interactions.

2 This contrasts with dietary supplements

3 that can alter hepatic detoxification pathways

4 resulting in inconsistent, under the curve levels

5 of prescription drugs. Unfortunately, some

6 manufacturers misrepresent their OTC products in a

7 manner that distorts the definition of homeopathic

8 drugs. We teach our students to be alert for

9 those who pass off their products as homeopathic,

10 and who undermine the very safeguards built into

11 the FDA CPG and the HPUS.

12 For example, we caution them regarding

13 products that combine dietary supplements with

14 homeopathic drugs and highlight the latter as

15 active ingredients, and the former as inactive

16 ingredients. By doing so, they attach a

17 homeopathic symptom indication, and in the process

18 circumvent the Dietary Supplement Health Education

19 Act's structure/function claim limitation.

20 This approach is not consistent with the

21 purpose of the existing public protection

22 mechanisms and it exposes the public to



50

1 potentially harmful substances such as adulterants

2 or nutrients with possible drug interactions. In

3 addition, naturopathic medical students learn that

4 some homeopathic drugs are wrongly marketed for

5 chronic conditions such as asthma, ignoring the

6 OTC limitation to self-limiting disease conditions

7 amenable for self-treatment.

8 Finally, our students learn to identify

9 ingredients mislabeled as homeopathic drugs that

10 not registered in the HPUS, have no research and

11 no clinical or safety background and no good

12 manufacturing processes to substantiate their safe

13 use. The college thus supports more rigorous

14 enforcement of existing policies to keep products

15 mislabeled "homeopathic" from the market or at

16 least cause them to be labeled as dietary

17 supplements.

18 In closing, I want to offer one last

19 point. Docere, doctor as teacher, and the Latin

20 root for the word doctor, is one of naturopathic

21 medicine's core principles. Docere plays a

22 prominent role in naturopathic medical students'



51

1 education. In addition to engaging and empowering

2 patients to make beneficial lifestyle changes such

3 as diet, exercise, and stress management, our

4 students teach patients and the public to

5 recognize the limitations of prescription and OTC

6 homeopathic medications.

7 I maintain that consumer safety

8 shouldn't rest solely upon regulation, but that

9 consumer literacy, ethical manufacturers, and

10 knowledgeable health professions are also

11 important. Therefore, it is incumbent upon other

12 health profession institutions, particularly

13 Schools of Pharmacy, to include in their over the

14 counter drug courses a section on homeopathic

15 drugs.

16 Educating pharmacists to understand the

17 regulatory framework provided by the CPG and the

18 HPUS will help their patients and customers make

19 sound and safe choices when selecting over the

20 counter homeopathic drugs. And I recommend that

21 the FDA continue to meet its public protection and

22 enforcement missions, in order to protect patients



52

1 who take prescription or over the counter

2 homeopathic medicines.

3 Finally, I recommend that the FDA should

4 be equipped with the resources necessary,

5 including staff well-versed in homeopathy, to

6 address the practice of marketing products labeled

7 as homeopathic, when those products have no

8 business being classified as such. Thank you.

9 Before questions, since I have a couple

10 of minutes, I would like to say happy birthday to

11 my mom who turns 85 today, in case she's watching

12 on the webcast.

13 DR. WHYTE: Eighty-five years young.

14 Hope -- did you give her the website?

15 DR. MITTMAN: I did.

16 DR. WHYTE: Okay, good. Happy Birthday

17 -- what's her name? We can all say --

18 DR. MITTMAN: Bernice.

19 DR. WHYTE: Happy Birthday, Bernice.

20 All right. Let's start with our questions for

21 five minutes. Let's start with Brad on the other

22 side.



53

1 MR. PACE: You mentioned a little bit

2 about what you said were supplement ingredients

3 listed in inactive --

4 DR. MITTMAN: I'm sorry?

5 MR. PACE: You mentioned a little bit

6 about supplement ingredients being listed in the

7 inactive ingredient list --

8 DR. MITTMAN: Correct.

9 MR. PACE: -- in products and that being

10 an issue. Is it possible -- aren't there some

11 overlaps between homeopathic ingredients and

12 supplement ingredients at all in terms of the

13 actual ingredient being potentially also a dietary

14 ingredient? And if so, how can that distinction

15 be made other than dilution?

16 DR. MITTMAN: Yes, Mr. Pace, the

17 question about homeopathic drugs having similar

18 origins to dietary supplements is true. However,

19 one is a drug and one is a food. So for example,

20 Aspirin is a drug, whereas white willow bark,

21 which is where acetylsalicylic acid was originally

22 derived, is a part of a tree and is therefore --



54

1 it would be classified as a food or in a -- if it

2 was an herb, it would be a dietary supplement.

3 The manufacturing process and strict

4 oversight provided by the CPG and HPUS renders one

5 a drug, as opposed to the other being a dietary

6 supplement or a food. Dr. Lostritto?

7 DR. LOSTRITTO: Yes, thank you. You

8 touch on a number of very important labeling-

9 related issues and some quality ones as well, and

10 I'm going to follow-up on the previous question

11 and then add one more. What labeling

12 recommendation would you propose to mitigate the

13 confusion that you describe where you have a

14 homeopathic ingredient with a dietary supplement

15 ingredient, which -- to just use a phrase -- is

16 being gamed to be treated in a different way as an

17 inactive ingredient and present maybe a misleading

18 picture number one.

19 And number two, what steps would you

20 take, since you mentioned it, products that really

21 have no basis in previous use that are introduced

22 without any controls, as you mentioned, if you



55

1 could highlight some of the problems there and

2 what you'd recommend on follow-up action for those

3 types of products as well.

4 DR. MITTMAN: Thank you. Regarding the

5 first, I don't believe that the hybrid product

6 that is conflating two different substances, a

7 drug on the one hand and a food or a dietary

8 supplement, is a labeling issue. I do not believe

9 that that product should be labeled homeopathic,

10 period. If it's labeled homeopathic, it should be

11 strictly homeopathic drugs.

12 Second question, could I ask you to

13 repeat the second question?

14 DR. LOSTRITTOS: Yes, the second

15 question was dealing with --

16 DR. MITTMAN: Got stuck on the first

17 question.

18 DR. LOSTRITTOS: -- with products that

19 have no basis in either previous use or lack of

20 GMPs and so forth, you mentioned which are on the

21 market and how would you recommend those be dealt

22 with or recognized?



56

1 DR. MITTMAN: With respect to substances

2 that do not either belong -- that are not either

3 in the HPUS or have gone through the process,

4 personally I don't think they should be labeled

5 homeopathic and a product that contains it should

6 not have the designation homeopathic.

7 DR. LOSTRITTOS: Understood, but what's

8 your recommendation as to how to follow-up and act

9 on those in terms of either enforcement or

10 labeling or a process to flag them and recognize

11 them? Because right now I don't know if they're

12 even recognizable.

13 DR. MITTMAN: I'm not an expert in

14 either regulatory affairs or enforcement, but I

15 would -- personally, if a product contains one of

16 those substances that you just described, it

17 should not have the designation homeopathic. If

18 it does, I assume -- but I could assume

19 incorrectly -- that the Food and Drug

20 Administration has the authority to send a letter

21 and have it be removed from the market. Yes, Mr.

22 Pace?



57

1 MR. PACE: Just kind of following up on

2 my previous question, an example can be zinc,

3 which can be in both a supplement and a

4 homeopathic and how to make kind of that

5 distinction between the two. I understand that

6 putting the label homeopathic on it is one way

7 with the dilution, but essentially they have two

8 different regulatory structures.

9 DR. MITTMAN: Yeah, so with respect to a

10 mineral and a homeopathic, I think the distinction

11 is if it is prepared according to homeopathic

12 principles and the homeopathic dilutions, it would

13 be termed homeopathic. If it's prepared as a

14 supplement, it would not. Thank you.

15 DR. WHYTE: Thank you, Dr. Mittman.

16 Your mother should be proud. You held up under

17 the questioning. With that, we'll turn to our

18 next speaker who is Will Woodlee, from the

19 American Herbal Products Association. Will Woodlee

20 MR. WOODLEE: Good morning. My name is

21 Will Woodlee and I'm a partner in the Washington,

22 DC law firm of Kleinfeld, Kaplan & Becker, LLP.



58

1 Today I offer testimony on behalf of the American

2 Herbal Products Association or AHPA.

3 AHPA thanks FDA for the opportunity to

4 share the following testimony in support of the

5 Agency's longstanding framework for regulating

6 homeopathic drug products, and in particular OTC

7 homeopathic drug products.

8 As background, AHPA is the only national

9 trade association focused primarily on herbal and

10 botanical products. AHPA's mission includes

11 promoting the responsible commerce of herbal and

12 botanical products, maintaining and improving

13 market opportunities for companies that sell

14 herbal and botanical products, as well as other

15 health-related products, and ensuring that

16 consumers continue to enjoy informed access to a

17 wide choice of goods including self-care products.

18 Founded in 1982, AHPA is the oldest of

19 the non-profit organizations that specialize in

20 service to the herbal products industry. It is

21 the voice of the herbal products industry and the

22 recognized leader in representing the botanical



59

1 trade. AHPA members include manufacturers and

2 distributors of homeopathic drug products.

3 For the four following reasons, AHPA

4 submits that FDA's present regulation of

5 homeopathic drug products, as outlined in

6 Compliance Policy Guide, section 400.400, provides

7 a sufficiently substantial regulatory platform for

8 homeopathic drug product oversight.

9 First, FDA's current regulatory

10 authorities and tools provide FDA with, or allow

11 the Agency to easily obtain, information on

12 homeopathic drug products and their manufacturers

13 to inform regulatory evaluation, planning, and

14 proposals.

15 The Federal Food Drug & Cosmetic Act

16 requires firms that manufacture drugs sold in or

17 offered for import into the United States, to

18 register their facilities and to list their drug

19 products with FDA. FDA's May 2009 guidance for

20 industry providing regulatory submissions in

21 electronic format, drug establishment registration

22 and drug listing describes in detail the various



60

1 and substantial information that firms must submit

2 for each drug listing.

3 From October 1 through December 31 of

4 each calendar year, firms must renew their

5 registrations and update their product listings as

6 appropriate. Firms also must submit this

7 information in electronic format, and the

8 requirements to register and list apply to both

9 prescription and OTC drugs.

10 While the Agency's databases contain

11 significant information on compliant firms and

12 their products, FDA may easily obtain information

13 on homeopathic drug products and manufacturers

14 that do not comply with these requirements, using

15 the Internet and other means.

16 Indeed, FDA's current surveillance and

17 investigative capabilities largely obviate the

18 need to conduct a formal regulatory process to

19 gather information on this product category, such

20 as the general OTC drug product review that FDA

21 initiated decades ago.

22 Existing regulatory authorities and



61

1 tools therefore provide FDA with a means of

2 identifying manufacturers, marketers, and products

3 as candidates for education, administrative

4 action, or enforcement action as necessary or

5 appropriate.

6 Second, FDA's current regulatory

7 authorities provide the Agency with information on

8 adverse events associated with OTC homeopathic

9 drug products sufficient to allow the Agency to

10 protect the public health. The 2006 dietary

11 supplement and Non- Prescription Drug and Consumer

12 Protection Act established requirements for the

13 reporting of serious adverse events associated

14 with OTC homeopathic drug products.

15 AHPA notes that although FDA has

16 received reports since the requirements took

17 effect, the law itself, as well as the MedWatch

18 forum used for reporting, state that submission of

19 a report does not constitute an admission that the

20 product in question caused or contributed to the

21 adverse event.

22 The existing reporting system thus helps



62

1 ensure that FDA receives information the Agency

2 needs to evaluate the relationship between the

3 event and product, if any. Current law also

4 requires manufacturers to maintain records of all

5 adverse events reported to them.

6 Under the current Good Manufacturing

7 Practice Regulations for Finished Pharmaceuticals,

8 manufacturers must maintain records and reports

9 regarding complaints. Where required, firms must

10 investigate those complaints and upon request make

11 their files available during FDA inspections.

12 Through inspections of manufacturing

13 establishments and investigations of mandatory

14 reports of serious adverse events associated with

15 homeopathic drug products, FDA currently has the

16 ability to investigate potential safety issues and

17 take any indicated follow-up action in a timely

18 manner.

19 Indeed, FDA historically has used its

20 tools and authorities to address perceived issues

21 involving homeopathic drug products including

22 recommending and overseeing recalls as well as



63

1 issuing warning letters.

2 Third, FDA's existing regulatory

3 framework for homeopathic drug products

4 appropriately reflects how these products

5 inherently present a very small safety risk due to

6 their ultra-dilute character. Nevertheless, other

7 mechanisms including reporting of adverse events

8 to FDA by poison control centers, healthcare

9 professionals, and the public, augment FDA's

10 acquisition of other signals of possible safety

11 issues, including from industry reports and

12 records.

13 Fourth, AHPA is not aware of any data

14 indicating that consumers perceive appropriately

15 marketed OTC homeopathic drug products as

16 substitutes for prescription drugs approved for

17 treating serious medical conditions. Labels of

18 such products much provide adequate directions for

19 use with OTC indications.

20 If an OTC homeopathic drug product is

21 inappropriately marketed for treating serious

22 conditions or with inadequate directions for OTC



64

1 use, FDA has authority to address the situation

2 and to effectively communicate any public health

3 concerns to healthcare professionals and the

4 general public.

5 In light of the adequacy of existing

6 regulatory framework for OTC homeopathic drug

7 products, AHPA urges FDA not to increase

8 regulatory burdens on manufacturers of such

9 products, which could limit consumer choice and

10 access to self-care products that in some cases

11 have been available for many decades. Thank you.

12 DR. WHYTE: Thank you. Let's start

13 closest to the podium.

14 MS. LIPPMANN: You state that AHPA's not

15 aware of any data indicating that consumers

16 perceive OTC homeopathic drug products as

17 substitutes for prescription drugs approved for

18 treating serious medical conditions. What about

19 the confusion consumers might have in just an OTC

20 environment, going into a pharmacy and seeing

21 homeopathic remedies comingled or right next to

22 other allopathic OTC products, often in packaging



65

1 that is made to be very similar?

2 MR. WOODLEE: So are you asking is AHPA

3 aware of data that suggests consumers are confused

4 about the differences between allopathic and

5 homeopathic products?

6 MS. LIPPMANN: I'm guessing you probably

7 don't have that data, but I'm asking more, is that

8 a concern that you would have?

9 MR. WOODLEE: I think AHPA will try to

10 answer this in its written comments that will

11 follow, but making sure I understand the question

12 correctly are you asking is AHPA concerned about

13 consumer confusion about the nature of products?

14 MS. LIPPMANN: Is it something that you

15 all have considered, thought about?

16 MR. WOODLEE: I think, generally

17 speaking, AHPA is concerned about consumer

18 confusion and interested in ensuring that

19 consumers understand what products are and what

20 the risks, limitations, and benefits of products

21 are, generally speaking.

22 MS. LIPPMANN: And I, as follow-up, I



66

1 would say we're interested in any information you

2 might have about whether consumers do understand

3 the difference between a homeopathic product and

4 its allopathic counterpart in the OTC context, and

5 what homeopathic products actually are.

6 MR. WOODLEE: Right. To the extent that

7 AHPA has a position on it and data that they could

8 provide to inform FDA's consideration of issue,

9 we'll include those in written comments.

10 MS. LIPPMANN: Thank you.

11 MR. WOODLEE: Thank you.

12 DR. LOSTRITTO: Thank you. Appreciate

13 your comments on the product, owner's

14 responsibilities if there's an adverse event and

15 records retention and so forth. I'm just curious

16 if your organization has a scientific arm which

17 also works to prevent those sorts of things from

18 happening in terms of product quality, ingredient

19 quality, process manufacturing controls and so

20 forth, if that's a part of your organization or

21 not?

22 MR. WOODLEE: Absolutely. AHPA's a



67

1 science-based organization. We maintain a full-

2 time scientific staff and we offer programming

3 related to a variety of issues including

4 scientific issues for its members and for the

5 larger arboreal industry.

6 DR. MICHELE: I note that you recommend

7 that FDA use the Internet, rather than a formal

8 regulatory process by which sponsors can submit

9 data to FDA, and I note that the Internet is a

10 really remarkable data source for everyone

11 including FDA, but we all know that there are a

12 whole variety of information that can be posted on

13 the Internet, the good, the bad, and the ugly,

14 some of which may or may not be of complete

15 voracity.

16 And I was wondering if you could provide

17 recommendations to FDA on how we could use that

18 data source to assure that we are getting the full

19 information on each product?

20 MR. WOODLEE: Sure. And I think I said

21 the Internet and other means, not suggesting that

22 the Agency would rely solely on the Internet in



68

1 the context of reviewing its Compliance Policy

2 Guide towards considering whether to continue it

3 or develop something else to replace it, but the

4 FDA is very experienced in processing what's on

5 the Internet and understanding the limitations and

6 the benefits of the available information.

7 But what I was suggesting, more

8 specifically, was that if the Agency's interested

9 in learning more about particular products that

10 are on the market to inform its regulatory

11 decision making, the Internet is one source that

12 it could use to do so, attending tradeshows,

13 visiting stores, and as well homeopathic medical

14 practices could also inform regulatory decision

15 making in this area, in particular provide the

16 Agency with information about the products that

17 are currently on the market.

18 UNIDENTIFIED SPEAKER: (Off mic).

19 DR. WU: Yes, just to follow-up the

20 possible confusion for the average homeopathic

21 consumer, because some of these are products made

22 originally from botanical materials. And so could



69

1 you recommend FDA to address this issue to prevent

2 the confusion of the regular botanical product and

3 for the homeopathic, you know, the agent made from

4 -- because these are two different products.

5 MR. WOODLEE: Could you repeat the

6 question? Are you -- or maybe I'll try to

7 paraphrase it to you and then you can let me know

8 if I'm understanding your question correctly.

9 You're asking how could FDA work to eliminate

10 potential consumer confusion between botanical

11 products and homeopathic products?

12 DR. WU: Right.

13 MR. WOODLEE: Certainly, as FDA is well

14 aware, we could study the issue and determine

15 whether there actually is a confusion issue and

16 then look at the labeling requirements in place

17 for both product categories to determine where the

18 confusion exists and try to address that through

19 changes.

20 MR. PACE: Given your association has

21 both supplement companies and homeopathic

22 companies, can you kind of comment on whether



70

1 traditionally supplement companies are now

2 starting to market homeopathic products and why,

3 if that's --

4 MR. WOODLEE: I'm not in a position to

5 comment about that now, but if AHPA has something

6 to add on that point, we'll include it in the

7 written comments.

8 DR. WHYTE: Thank you.

9 MR. WOODLEE: Thank you.

10 DR. WHYTE: Up next is Youngran Chung

11 from Northwestern University Feinberg School of

12 Medicine, and the Ann & Robert H. Lurie Children's

13 Hospital of Chicago. I hope I pronounced your

14 name correctly. Close? Youngran Chung

15 DR. CHUNG: Almost.

16 DR. WHYTE: Okay.

17 DR. CHUNG: Hi, I'm Youngran Chung and

18 good morning. I'm a full-time physician at the

19 Ann & Robert H. Lurie Children's Hospital of

20 Chicago, formerly known as Children's Memorial

21 Hospital, and I'm in the Division of Pulmonary

22 Medicine. I'm also an assistant professor of



71

1 pediatrics at Northwestern University Feinberg

2 School of Medicine in Chicago.

3 Prior to this, I was the director of

4 pediatric pulmonology and the cystic fibrosis

5 center at academic institutions for almost two

6 decades in Chicago. I'm also board certified in

7 integrative medicine, and am one of the

8 instructors for the Center for Education and

9 Development of Clinical Homeopathy, which is a

10 physician-based homeopathic teaching organization

11 that is active worldwide.

12 I am here mainly to share my clinical

13 experience with using homeopathy. So how does

14 someone like me with my conventional medical

15 background as a board-certified pediatric

16 pulmonologist get into integrative medicine and

17 specifically get interested in homeopathy?

18 As a clinician, I was treating hundreds

19 of children with various pulmonary disorders and

20 realized the limitation of the western medical

21 approach. I became intrigued by the idea of

22 treating diseases like asthma by more natural



72

1 means, such as nutrition, acupuncture, and other

2 alternative medicines that are in use in some

3 other cultures around the world.

4 I was also inspired by my patients and

5 medical students who were asking about more

6 natural or non-pharmacological ways to treat

7 asthma. So I first studied, trained, and became

8 board-certified in medical acupuncture, and

9 discovered that yes, there are other ways to help

10 treat asthma, as well as other pulmonary problems

11 beyond drugs alone.

12 I also knew that there are other

13 complementary alternative modalities, and this led

14 me to train in homeopathy. So here's my clinical

15 experience with homeopathy. I have found

16 homeopathic medicines to be a very valuable

17 addition to my practice and here's how.

18 I have many, many patients who seek

19 alternative ways to treat their child's asthma.

20 What was first attractive about homeopathy is its

21 inherent safety. My use of homeopathy does not

22 interfere with standard of care practice. I



73

1 prescribe all the standard asthma drugs, and I may

2 add homeopathic medicines to lessen the intensity

3 of the symptoms, prevent triggers or alleviate the

4 comorbid conditions of asthma.

5 The goal I have with my patients is to

6 decrease their reliance on drugs. I also find

7 homeopathic medicines valuable for medical

8 conditions where we have no specific effective

9 drugs or for situations where the child cannot

10 tolerate the side effects of drugs.

11 So, for example, I have seen good

12 results when I have used it to alleviate chronic

13 cough from various reasons like bronchorrhea,

14 habit cough and so on, and also to treat dyspnea

15 due to vocal cord dysfunction syndrome. It's also

16 been useful for acute symptoms of RSV

17 bronchiolitis, which is a respiratory illness in

18 infants with no specific drugs to alleviate acute

19 symptoms, and also for prevention of recurrent

20 croup which allows us to decrease emergency

21 department visits.

22 These are just some examples of how I've



74

1 used homeopathy and how I've found it to be a

2 valuable tool in practicing integrative medicine.

3 One of my missions is to educate other physicians

4 as they may be fielding questions from their

5 patients about homeopathy.

6 This inspired me to publish articles on

7 homeopathy for medical journals and textbooks,

8 including review articles in peer-reviewed

9 journals, such as The American Academy of

10 Pediatrics Illinois newsletter, also Pediatric

11 Pulmonology, and also Current Opinions in

12 Pediatrics which is in press, as well as give

13 presentations on homeopathy at allopathic medical

14 conferences including the Annual North American

15 Cystic Fibrosis conference, as well as homeopathic

16 conferences in the U.S. and in Europe.

17 Now, I'd like to tell you about my

18 patients' attitude towards homeopathy. I get many

19 referrals for pulmonary consultations the same way

20 my colleagues do, my pulmonary colleagues in my

21 division. When I suggest trying a homeopathic

22 medicine for my pediatric patient, the parents are



75

1 almost always willing to use it, because I provide

2 them information on what homeopathy is, for what

3 purpose we would use it, and what its limitations

4 are.

5 I also have patients who seek

6 consultations from me, specifically because they

7 know I use homeopathy, and they've heard it from

8 other families how it has helped them. So I

9 reiterate that I find it essential, in my

10 practice, to offer homeopathic medicines in

11 situations where I think it may be appropriate and

12 helpful.

13 Now I'd like to answer questions posed

14 by the Federal Register notice. Number one,

15 consumer and healthcare provider attitudes towards

16 products labeled homeopathic. Many physicians are

17 unfamiliar with homeopathy. I often use

18 homeopathic medicines for their patients they

19 refer to me for consultations, and once they learn

20 that it is safe and effective, they refer other

21 patients for homeopathy.

22 Many patients can be unfamiliar with



76

1 homeopathy, but they're almost always open to try

2 it, because they learn about it and when they're

3 given the option, they are comfortable trying it.

4 And I have not had patients go out then willingly

5 buy homeopathy off the shelf. If they do get

6 curious about, Well, would it also help my

7 headache in addition -- is there something that

8 might help my headache -- they will always come

9 and ask me. So I find them to be pretty

10 responsible when they try to self-treat.

11 Second question is what data source

12 exists to better assess homeopathic products? I

13 think that organizations such as the Homeopathic

14 Pharmacopoeia Convention of the U.S., the AAHP,

15 major homeopathic educational organizations such

16 as the Center for Education and Development of

17 Clinical Homeopathy, the American Institute of

18 Homeopathy, and also manufacturers, some of you

19 already heard from today and yesterday, and I

20 believe all are present at the meeting or will be

21 filing more comments.

22 The last question, I believe question



77

1 number eight, is do consumers and healthcare

2 providers have adequate information about drug

3 products labeled as homeopathic? Most products

4 labeled homeopathic do provide information about

5 and when to use it, and I think it should continue

6 to be regulated like other OTC medicines.

7 Now I do find that many physicians are

8 unfamiliar with homeopathy and confuse it with

9 herbal supplements. And to make matters worse,

10 there are products labeled homeopathic, but also

11 contain herbal ingredients, and this is a problem

12 since herbs can potentially have side effects. So

13 I'd like to stress that any product that is a

14 mixture of homeopathic with other ingredients,

15 such as herbals, should not be labeled

16 homeopathic, as this can be misleading for the

17 consumer.

18 In closing, from my experience of using

19 homeopathic medicines, I can attest to the fact

20 that homeopathics are safe, effective, and a

21 valuable addition to my practice. It is one of

22 the most widely used complementary alternative



78

1 modalities in the world, and fortunately in the

2 U.S., homeopathic products are regulated to assure

3 good quality of medicines. And this is important

4 as increasing number of physicians and consumers

5 are using it, because they find it to be a

6 valuable complement to their medical care. Thank

7 you.

8 DR. WHYTE: Thank you, Dr. Chung. We'll

9 start our questions with Richard and then we'll

10 turn to Judith and then Charles.

11 DR. LOSTRITTO: Hi. Thank you very

12 much. In one of your responses you mentioned that

13 for consumers, certain reliable brands do provide

14 basic information about how and so forth. I'm

15 just curious how you determine or define reliable

16 brand. What is your process? Is it based on the

17 quality of the product itself, or the clinical

18 response you see, or the written information? I'm

19 just curious what your determinant is for reliable

20 brand?

21 DR. CHUNG: Yes, that's a question that

22 could be generalized to any over the counter



79

1 products, whether it be herbals or homeopathics.

2 So I can generalize it that I would use -- I would

3 find the manufacturer as well-established, has

4 been around for a long time. I also rely very

5 much on my colleagues who are in integrative

6 medicine and have researched it even more than I

7 have, by talking to manufacturers and so on, and

8 familiar with the process of how the product is

9 made.

10 DR. MCMEEKIN: Thank you for your

11 presentation. What would you recommend to

12 consumers and healthcare providers to be able to

13 make informed decisions about homeopathic products

14 that they are choosing to use?

15 DR. CHUNG: In my practice, because I

16 have to see a lot of patients, I have actually a

17 video that explains what homeopathy is from A to

18 Z, and I really am impressed that the consumers or

19 patients understand it. You know, they have some

20 questions, but I have not had a problem where they

21 just don't get it.

22 And so I find educating consumers that



80

1 way, in the office, as well as maybe inserts, and

2 I know that some brands, over the counter have

3 little pamphlets about homeopathy is, but I do

4 think that more in-depth education would be

5 helpful.

6 And then what I was going to mention is

7 that it -- as I said, one of my missions is to

8 educate the pediatricians and the family practice

9 doctors and other healthcare practitioners, the

10 nurse practitioners, so on, about what homeopathy

11 is, because they are fielding questions from their

12 patients. And if they don't know what homeopathy

13 is and confuse it with herbs or otherwise, I find

14 that they're the ones who need more education.

15 DR. WU: In your presentation, so you

16 use asthma as a paradigm to conclude that

17 homeopathic medicine is safe and effective. And

18 so I just wonder -- so based on what kind of

19 evidence you drew such a conclusion. Is it

20 through the well-designed clinical trial or is

21 just your personal practice and experience.

22 DR. CHUNG: Yes. Well, I'm not doing



81

1 clinical research. Now when it comes to asthma,

2 it is truly an integrative approach. I use

3 inhalers, steroids, all the usual asthma drugs,

4 and I add homeopathic medicines. So I start from

5 a clean slate where they're using the standard

6 practice. I add homeopathic medicines that will

7 reduce their tendency to have episodes or reduce

8 their intensity or reduce the triggers of asthma.

9 And over time, as you know, it has to be

10 very longitudinal assessment, season to season --

11 you know, I assess how often they've been to the

12 emergency department, how often they might have

13 used their bronchodilators. So that's really how

14 I assess how they do.

15 Now there are, as I mentioned, other

16 than asthma, some instances where homeopathic

17 medicines alone, I have seen effect; for example,

18 vocal cord dysfunction syndrome. Yes, you can do

19 speech therapy and so on, but they come with no

20 medicines on board, because there's no particular

21 medicine for that disorder. I put them on

22 homeopathic medicine. I can see a clear result



82

1 before and after. But coming back to asthma,

2 that's a very integrative approach and it takes a

3 long time to make that assessment fairly.

4 DR. WU: Another question related to

5 that. So you use just a single product or you use

6 various homeopathic drugs to get same conclusion?

7 DR. CHUNG: Yes. Almost all my practice

8 is single product, because I think when you say

9 non- single products, you're referring to the

10 multiple combination products that are on the

11 shelf. My practice is to recommend single

12 products of -- different single products.

13 DR. WU: Thank you.

14 DR. WHYTE: Thank you. Okay, we have

15 one more speaker before the break, and that is

16 Ronald Boyer from the Center for Education and

17 Development of Clinical Homeopathy. Welcome, Mr.

18 Boyer. Ronald Boyer

19 MR. BOYER: Good morning. First of all,

20 I'd like to thank the panel and the attendees for

21 their patience, listening to me. I also want to

22 mention that I'm here representing the center and



83

1 that the center will not be reimbursed for my

2 presence today.

3 So my credentials: I'm currently the

4 president of the Center for Education and

5 Documentation of Clinical Homeopathy in the U.S.

6 You've seen some of my teachers today. I'm also a

7 member of the Homeopathic Pharmacopoeia of the

8 United States.

9 I've travelled a lot, so I'm a founding

10 member of the International Medical Homeopathic

11 Organization and an honorary member of the South

12 African Medical Homeopathic Association. I have a

13 doctorate in medicine from Montpellier Medical

14 School in France, and I have two homeopathic

15 specialty degrees from both of France's premiere

16 accrediting homeopathic educational institutions.

17 And finally, I'm the co-author of 10

18 books on homeopathy and I've treated patients with

19 homeopathic medicines for more than 30 years. And

20 I always hate to say this, but I graduated in

21 1978, and I've been teaching since the 1980s. I

22 used to be pretty proud of those figures before,



84

1 and now I'm getting a little bit worried about

2 them.

3 Let's talk a little bit about the CDH.

4 The CDH offers, to licensed physicians, training

5 on clinical homeopathy. The CDH, its purpose is

6 to give every physician worldwide, in fact, the

7 possibility of being able to integrate homeopathy

8 in their daily practice, if they wish.

9 We try to give them the most reliable

10 knowledge of homeopathy in a very clear,

11 pragmatic, and clinical approach. The CDH is the

12 largest homeopathic clinical school in the world.

13 We teach in more than 20 countries worldwide, and

14 more than 3-5,000 physicians pass through the CDH

15 every year.

16 Right here in the U.S., we already have

17 more than 1,000 medical professionals passing

18 through the course, and the registration is open

19 in fact to MDs, DOs, PAs, nurse practitioners,

20 mid-wives, and in fact to medical professionals

21 with prescription rights.

22 What we do in homeopathy, we teach



85

1 single medicines. We do not teach the mixed --

2 the complexes. An important thing, I just wrote

3 it down and I'd forgotten about that, when you're

4 in medical school, at least when I was in medical

5 school, the first thing they taught us when we

6 were going out is learn how to refer, learn how to

7 refer.

8 The same thing in homeopathy. There are

9 things we can treat with homeopathy. There are

10 things that we can treat, but must be associated

11 often to allopathic medicines, and some things we

12 can't do. And that is what we teach at the CDH,

13 because not only do we want to give our patients

14 no harm, we want to be responsible for what we're

15 doing.

16 So I'm trying to answer -- I have a

17 French background, so when you ask questions, I

18 like to give the answers. Question number one,

19 what are consumer and healthcare provider

20 attitudes towards human drug and biological

21 products labeled as homeopathic?

22 To start, I want to start with a little



86

1 anecdote. When I was lecturing here in the U.S.

2 in the 1980s and I was flying a lot and I was

3 sitting beside one of my colleagues, the colleague

4 said, What do you do? And I said, Well, I teach

5 and I do homeopathy, and the conversation had a

6 tendency to stop right at that moment and take the

7 U.S. Airways magazine and put your nose in it.

8 Right now, since then, homeopathy has

9 really been -- soared in the U.S., not only with

10 patients, but also with practitioners, and I have

11 to always go around with my business cards to talk

12 about them, because they want to know what the CDH

13 is, what homeopathy is, and in fact, at certain

14 times you have to put bows and those reducing

15 things and say, Okay, now let's try to rest a

16 little bit.

17 So what they want, the HCPs want the

18 knowledge to answer their patients' questions,

19 because patients are getting very interested in

20 homeopathy. They don't always know what it is.

21 Often, they don't know what it is at all, and

22 they're asking their HEPs. A lot of healthcare



87

1 practitioners are looking for another tool to add

2 to their arsenal.

3 They are curious and they're attracted

4 to homeopathy by the fact, first of all, that it's

5 safe, it's reliable, it has no side effect, and it

6 does not interfere with other medications, which

7 is going to bring questions from the panel a

8 little bit later, I'm certain.

9 And many HEPs want to differentiate

10 their practice. They want to offer a large range

11 of therapeutic methods. Homeopathy is not a new

12 method. Homeopathy has been going on for 200

13 years. So I understand there's a lot of research,

14 there's a lot of double-blind, but there's also

15 real life. Real life. And the real life is what

16 all the physicians practicing homeopathy see in

17 their practice, is seeing the improvement we can

18 have on patients.

19 I mean I think we're not stupid. I mean

20 if patients had no improvement with homeopathy, we

21 would probably do something else. The HEPs that

22 follow the CDH course invest a lot of time and



88

1 money. They travel. They attend the eight

2 weekend courses offered in seven cities in the

3 U.S. And my students (sic) doctors experience

4 with homeopathic medicine after graduation serve

5 as examples of HCP attitudes towards integrating

6 these products into their practice.

7 At the CDH we have a web forum in which

8 we have 800 physicians on board, and when they

9 have problems, when they have questions, or when

10 they have compliments (sic) on homeopathy, they

11 write it on the web forum, and you have 800 people

12 reading them in real time, which is extremely

13 positive, which shows that you're doing things

14 right, that your doctors are doing things right,

15 and that the patients are getting a lot of

16 positive things from the homeopathy.

17 I brought -- I didn't bring in a lot of

18 testimonies. I just brought two. I brought one

19 from Dr. Albert Levy who is an M.D. who practices

20 in New York who says, "I'm a family physician. I

21 incorporate homeopathy in my practice when

22 appropriate. My patients love it. They



89

1 appreciate the fact that there are no side

2 effects, no contraindications, and more

3 importantly, they appreciate that their doctor is

4 open to other methods of therapy."

5 Dr. Levy was one of the CDH students in

6 the 1980s, and he's had a very popular homeopathic

7 practice since then. Then Rachel Jones and Nancy

8 Lawrence (ph) who are midwives, "We have patients

9 that ask us for something else that will help them

10 during pregnancy, post-partum, or with a health

11 problem on a daily basis. We now have a safe,

12 trusted, therapeutic alternative to offer to the

13 women we care for. Many have come back to ask us

14 about treatment for family members or have

15 referred other women to us."

16 Question number two, what data sources

17 can be identified or shared with FDA so that the

18 Agency can better assess the risk and benefits of

19 homeopathic drug products? As an institution with

20 a primary goal of contributing to the safe and

21 responsible practice of homeopathy, the CDH

22 considers itself as a source of information. The



90

1 ultimate goal of our community is to provide the

2 best homeopathic medicines and not to harm our

3 patients.

4 I've had the privilege of practicing and

5 teaching in three continents, and in each one, I

6 always took care to respect the homeopathic

7 pharmacopoeia of each country, which in fact

8 there's not major differences between the European

9 Pharmacopoeia, and the pharmacopoeia here in the

10 United States. So I teach my students, HCP

11 students to do the following.

12 First of all, use medicines that state

13 HPUS after active ingredients on the packaging.

14 To me, this ensures the quality of the product as

15 it is prepared under the HPUS guidelines. Second

16 thing, refer to the HPUS, which indicates not only

17 the name of the medicine, but which dilutions can

18 be recommended for OTC conditions or for Rx

19 conditions, or for external use, whatsoever.

20 So the HPUS does not only give you the

21 name of the medicine; it also gives you the

22 different dilutions and the different usages. And



91

1 the same applies to brand name homeopathic

2 complexes, meaning products that contain at least

3 one monographed HPUS substance, and has an OTC

4 indication.

5 Most of them do, but of course, we've

6 heard during the hearing these two days, that some

7 of these complexes are presenting with indications

8 that are absolutely not OTC and those are the ones

9 that create a problem.

10 Question number eight, do consumers and

11 healthcare providers have adequate information to

12 make informed decisions about drug products

13 labeled as homeopathic? If not, what information,

14 including for example, information in labeling,

15 would allow consumers and healthcare providers to

16 be better informed about products labeled as

17 homeopathic?

18 I can talk mainly about my doctors.

19 They expect reliable, that is quality manufactured

20 medicines with industry standard labels bearing

21 clear information. They also want those products

22 to be well-stocked in common retail outlets, so



92

1 that the patients can conveniently treat their

2 condition, knowing mostly, as I mentioned before,

3 that the students passing through the CDH learn

4 mainly about the single medicines and not the

5 complexes.

6 Again, the answer here is very simple.

7 HCPs and consumers alike should check on product

8 labels that HPUS is indicated for the homeopathic

9 active ingredient and having HPUS on the label is

10 certainly one of the indicators of quality.

11 Conclusion. The regulation of

12 homeopathic drug products through their 25-year-

13 old Compliance Policy Guide, CPG 400.400, has

14 worked well. I believe the mass majority of the

15 products accessible to my doctors and their

16 patients are manufactured and labeled in

17 compliance with the HPUS and the CPG.

18 This ensures high-quality medicines that

19 are easy to identify for healthcare needs. The

20 rules and regulations for OTC and Rx homeopathic

21 medicines have been established by the FDA and the

22 HPUS. Since the Homeopathic Pharmacopoeia of the



93

1 United States body does not have regulatory

2 oversight on claims on branded products, my

3 recommendation to FDA is to enforce the current

4 regulation for products that are manufactured

5 outside of these HPUS guidelines.

6 The many homeopathic products offered by

7 manufacturers and retailers and recommended by

8 physicians, extends and provides value like a

9 strong and healthy tree. And here's my little

10 French side, my little poetic side, "It would be

11 unproductive to cut the whole tree, when only a

12 few troublesome branches need to be pruned."

13 Thank you for your attention.

14 DR. WHYTE: Thank you, Dr. Boyer. We're

15 not on the break yet, very soon. You know, Dr.

16 Woodcock is a big gardener, so she would have

17 liked to have heard earlier on. We'll tell her.

18 Okay, let's start with our five minutes of

19 questions. We'll start with Richard.

20 DR. LOSTRITTO: Yes, thank you. You

21 mentioned the expectation for quality. I'm just

22 curious if in the many years of your -- and your



94

1 many travels, if you've had the opportunity to see

2 homeopathic products actually being made? And

3 again, at the risk of sounding like a broken

4 record from yesterday, it's clear I have an

5 interest in what happens in the development of

6 those products from the time the active ingredient

7 is accepted, to the time the final product is

8 released and what goes on in between is of

9 interest to me.

10 Have you seen these products

11 manufactured, and if so, do you see a spectrum in

12 product knowledge and manufacturing knowledge,

13 even within the compliance to good manufacturing

14 practices?

15 DR. BOYER: Now are talking exclusively

16 about the United States or around the world?

17 DR. LOSTRITTO: Products that would be

18 available in the United States.

19 DR. BOYER: Products available in the

20 United States. No, as far as the single medicines

21 in the United States, all the ones I've

22 encountered are made by major reputable



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1 homeopathic companies here, and the quality is --

2 the reliability and the quality is pristine.

3 DR. MICHELE: Thank you for your

4 presentation. You noted that you recommend that

5 products be identified as appropriate if they

6 contain monographed HPUS substances and have an

7 OTC indication. And then, you go on and talk

8 about rules and regulations applying to OTC and

9 prescription homeopathic products. So I was

10 wondering if you could comment further about how

11 the FDA can determine which homeopathic products

12 should be prescription and further, if there are

13 additional regulatory requirements that should be

14 applied to prescription homeopathic products.

15 DR. BOYER: Okay. So if we look at the

16 two products, if we look at the single medicines,

17 the single medicines that patients will find in

18 retail stores are in such dilutions that they will

19 be over the counter anyway. I mean I don't think

20 that a patient will come into a Whole Foods, for

21 example, and say, Oh my gosh, I have this or that.

22 I'm just going to take -- pick a medicine off the



96

1 shelf.

2 I think the major problem are the OTC

3 complex medicines, which sometimes have

4 indications that are absolutely not over the

5 counter, which need medical help. And even I've

6 heard of some single medicines that have not --

7 that are not on the HPUS. So the regulation is

8 mainly on the possibility of patients being able

9 to treat themselves with over the counter

10 medicines that are indicated for not over the

11 counter indications.

12 DR. MICHELE: And just to follow-up on

13 that, so if you have an indication that is not an

14 OTC indication, how do you determine that, and

15 further do you feel that there should be

16 additional regulatory requirements for

17 prescription homeopathic products?

18 DR. BOYER: Well I think that the

19 specialties or the complex that are non-OTC are

20 very few in fact in the market. I don't really go

21 around all the different retail stores to see what

22 it is, but I think we've talked about it several



97

1 times. I've heard that there is an OTC medicine

2 for asthma, which is not an acute condition, which

3 is a chronic condition. That is the sort of

4 condition, that is the sort of labeling that has

5 to be regulated by the FDA.

6 DR. WHYTE: Charles?

7 DR. WU: (Off mic).

8 DR. BOYER: Okay. Thank you.

9 DR. WHYTE: Thank you, Dr. Boyer.

10 DR. BOYER: Thank you. Excellent

11 (inaudible), thank you.

12 DR. WHYTE: Okay. Well now we will have

13 our 15-minute break. We're a little ahead of

14 schedule, but we're going to stick to a 15-minute

15 break. It is 10:45, so let's resume promptly at

16 11:00. Thank you.

17 (A recess was taken.)

18 DR. WHYTE: All right. Let's go ahead

19 and get started and we will have another trio

20 that's presenting - J.P. Borneman, Gary Yingling,

21 and Todd Hoover from the Homeopathic Pharmacopoeia

22 Convention of the United States. J.P. Borneman



98

1 DR. BORNEMAN: Thank you, Dr. Whyte,

2 panelists. Good morning. Hope everybody is

3 adequately caffeinated after a break. So good

4 morning, everyone. I am J.P. Borneman. I'm

5 president of the Homeopathic Pharmacopoeia

6 Convention of the United States. I'm also

7 privileged to be chairman and CEO of Standard

8 Homeopathic Company, a homeopathic manufacturer

9 that dates back to 1903. I'm grateful to the

10 Agency for this opportunity to present to you this

11 morning.

12 I'm joined today by Mr. Gary YingLing,

13 general counsel of the HPUS, and Dr. Todd Hoover,

14 a member of the HPCUS Board of Directors, and

15 chairman of the HPCUS Clinical Data Working Group.

16 Today, we're going to provide an overview of the

17 role of the HPCUS and the Homeopathic

18 Pharmacopoeia in ensuring the safety and quality

19 of homeopathic drug products.

20 We'll also provide an overview of the

21 well-defined standards for the last quarter

22 century under which homeopathic products have been



99

1 sold. These standards are peer-reviewed and

2 updated continuously, so that consumers and

3 physicians can be confident in homeopathic product

4 quality.

5 Homeopathic products sold in the United

6 States are well-served by the existing and

7 regulatory structure and we look forward to

8 explaining HPCUS role in providing consumers and

9 clinicians access to safe, high quality,

10 homeopathic medicines. We are confident that the

11 majority of homeopathic drug products in the

12 market are manufactured and labeled in substantial

13 compliance with Compliance Policy Guide 400.400

14 and the Federal Food, Drug and Cosmetic Act.

15 Importantly, where products are not

16 following the Compliance Policy Guide, FDA has the

17 ability to act and to act promptly. We believe

18 that the regulatory structure is adequate to meet

19 the needs of consumer access and ensuring

20 standards of quality by homeopathic drug

21 manufacturers and that the HPCUS has been

22 successful in supporting FDA's public health



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1 mission.

2 I'd like to provide some context on the

3 history and the role of HPCUS as it is an

4 important element of the current functioning

5 regulatory framework governing the manufacturing,

6 labeling, and marketing of homeopathic medicines

7 in the United States.

8 The Homeopathic Pharmacopoeia of the

9 United States has been in continues publication

10 since 1897. Under the auspices of the American

11 Institute of Homeopathy, the HPUS was published in

12 eight sequential editions between 1897 and 1980,

13 with the addition of the Compendium of

14 Homeotherapeutics in 1974.

15 In 1980, the Homeopathic Pharmacopoeia

16 Convention of the United States was independently

17 incorporated as a separate 501(c)(3) organization

18 and it is this NGO, the HPCUS, that has published

19 the Homeopathic Pharmacopoeia for the past 35

20 years.

21 In 1982, a Supplement A was published

22 and the priority of the Pharmacopoeia Convention



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1 was to complete the monographs that were already

2 listed in the Compendium of Homeotherapeutics.

3 That task was ongoing for more than a decade

4 culminating in the HPUS revision service that was

5 published between 1992 and

6 2004.

7 In 2004, the HPUS became an online

8 publication with nearly continual updates that can

9 be accessed via subscription service. The HPCUS

10 sets the standard for the production of high

11 quality homeopathic medicines to the consuming

12 public, with an emphasis on safety.

13 A seven-member board, plus an emeritus

14 trustee, govern the HPCUS. Of the seven members,

15 four are clinicians who meet the criteria for

16 independence.

17 The activities of the Convention fall

18 into several key areas: Drug monograph

19 evaluation, pharmaceutics and pharmaceutical

20 methods including GMPs, generation and evaluation

21 of standards and controls parameters, continual

22 safety and toxicology evaluation, and continuous



102

1 improvements to methods of data collection and

2 evaluation.

3 The work of the Convention are conducted

4 by two half-time staff: An editor who has more

5 than 40 years of service to the HPCUS, and a

6 senior scientist who was added to the team in

7 2009. The balance of the work of the HPCUS is

8 conducted by 54 volunteer members composed of

9 clinicians, chemists, pharmacists, botanists,

10 toxicologists, and policy experts.

11 These members participated in more than

12 30 in-person and telephonic committee meetings,

13 including several hundred hours of contact time

14 last year alone. Mr. YingLing will give you an

15 overview of the legal status and legislative

16 history of the HPCUS and how the HPUS and the CPG

17 create an appropriate regulatory framework for

18 homeopathic drugs. Mr. YingLing? Gary YingLing

19 MR. YINGLING: Good morning. My name is

20 Gary YingLing and a senior counsel at Morgan,

21 Lewis and Bockius, and I have acted as the

22 Homeopathic Pharmacopoeia Convention of the U.S.



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1 general counsel for over 25 years. As the general

2 counsel, I have advised the HPCUS on the laws,

3 regulations, and policies governing homeopathic

4 drugs.

5 There's a long and thoughtful history of

6 the regulation of homeopathic drugs in the United

7 States dating back to 1906, with the first

8 legislation that created a federal statute in

9 relationship to regulating food and drugs. The

10 1906 Act listed the United States Pharmacopoeia

11 and the National Formulary as compendial

12 references.

13 In 1912, a bill was introduced by

14 Senator Gallinger, to include the HPUS in the 1906

15 Act. That legislative effort was unsuccessful.

16 By the early 1930s, there were efforts made to

17 basically make significant changes in the 1906

18 statute, and that was done by Senator Tugwell.

19 That effort was rejected and Tugwell backed away

20 from that legislation, but it was picked up in

21 1934 by Senator Royal Copeland from New York, who

22 was a homeopathic physician.



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1 He became the major sponsor of that

2 legislation, and in that legislation he included

3 references to the HPUS. It took until 1938 to

4 gain passage of the legislation, and when the bill

5 was passed it contained a definition of drug that

6 included substances that are listed in the USP,

7 the National Formulary, and the HPUS.

8 To this day, that statutory language

9 continues to state that the term "drug" means,

10 articles recognized in the USP, HPUS, and National

11 Formulary.

12 Much later, in 1972 FDA was preparing to

13 publish the final regulations for the OTC drug

14 review and Commissioner Charlie Edwards and

15 general counsel, Peter Barton Hutt, met with a

16 representative of the homeopathic community to

17 discuss the review as it related to homeopathic

18 drugs.

19 During that meeting, which I was able to

20 attend, the Agency decided that it would in best

21 to review homeopathic drugs in a separate review

22 that would occur after the OTC drug review. That



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1 determination was reflected in comment 25, which

2 appeared in the preamble to the final regulations

3 published on May 11th, 1972.

4 As the director of the OTC review in

5 those early years, I never heard anyone question

6 or raise a concern about the fact that homeopathic

7 and non-homeopathic drugs had been separated as

8 far as a review was concerned. In 1988, the FDA

9 issued a Compliance Policy Guide to set forth

10 conditions which homeopathic drugs may be

11 marketed, that clearly set a standard for the

12 industry, and as the HPCUS counsel, I witnessed

13 every effort to comply with the Compliance Policy

14 Guide.

15 And as you're probably aware, it was

16 updated in 1995. Over the 77 years since the 1938

17 Act was passed, FDA has regulated both homeopathic

18 and non-homeopathic drugs, and on occasion it has

19 taken actions in relationship to misbranding or

20 adulteration.

21 One would assume that Senator Royal

22 Copeland would be pleased that the fruits of his



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1 efforts to recognize the diversity of the medical

2 practice and the various drugs used in those

3 practices, continues today. Thank you.

4 DR. BORNEMAN: Thank you, Gary. To

5 create a greater understanding of the framework,

6 I'd like to familiarize you with the HPUS drug

7 monographs. There are currently 1,295 approved

8 monographs in the Homeopathic Pharmacopoeia of the

9 United States. Only nine have been approved in

10 the last decade, most of which were already in

11 clinical use in Europe.

12 The approval of these nine new

13 monographs stands in contrast to a much larger

14 number of 500 that appeared in the Federal

15 Register. The point of confusion may have been

16 related to a large number of pre-existing

17 monographs that had been updated.

18 In addition to the monographs, the

19 Convention embarked on creating full quality

20 control specifications and controls data for the

21 approved monograph substances. The order in which

22 the substances were handled was risk based. It



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1 was associated with the prevalence of use of the

2 substance, and the chemical characteristics of the

3 substance.

4 As of April the 1st of this year, 497

5 such quality monographs had been published and the

6 process is ongoing. From a safety perspective,

7 the HPCUS has published drug data tables that

8 specify the lowest, safe, homeopathic potencies

9 for over the counter prescription and APIs, also

10 known as homeopathic pharmaceutical necessities.

11 These data are under constant review

12 with changes being made as necessary, in order to

13 meet ICH guidelines. From a pharmaceutics

14 perspective, the guidelines for homeopathic

15 manufacturing section was completely rewritten

16 over a three-year period ending in 2014. It has

17 gone through the public comment period, including

18 very helpful input from FDA, and is scheduled for

19 implementation in 2017.

20 Additional accomplishments at HPCUS

21 over the life of the CPG include the addition of a

22 list of official short names, minimum safe potency



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1 tables, official synonyms and sections on

2 guidelines for manufacturing homeopathic

3 medicines, homeopathic good manufacturing

4 practices, and labeling guidelines. And with this

5 background, I'd like to ask Dr. Hoover to walk us

6 through the process by which we review monographs.

7 Todd Hoover

8 DR. HOOVER: Good morning. My name is

9 Todd Hoover. I'm a director for the HPCUS and

10 have no conflicts of interest regarding any of the

11 information I'll present today. I'm a board-

12 certified family medicine physician, and for the

13 past 30 years I have had clinical experience as a

14 Navy medical officer, as an emergency room

15 physician, and as a medical director of a Fortune

16 50 company.

17 I've also had over 2,000 hours

18 specifically for training in homeopathy. My work

19 in the HPCUS is focused on increasing the

20 scientific rigor, transparency, and clinical

21 relevance of the monograph review process. All

22 monographs are subject to the monograph review



109

1 procedure outlined in the HPCUS procedure manual

2 and the criteria for eligibility outline in the

3 HPUS.

4 All new monographs are first reviewed by

5 the editor. Then, complete and compliant

6 monograph packets are forwarded to two working

7 committees within the convention to perform

8 technical analysis. These working groups are the

9 Monograph Review Committee and the Pharmacopoeia

10 Revision Committee. Let's look at each group.

11 First, the Monograph Review Committee is

12 composed of experts in homeopathic pharmacy,

13 toxicology, and analytic methodology. This

14 committee evaluates the submitted monograph for

15 compliance to both ICH and FDA standards for GMP

16 and safety as they apply to homeopathic medicines.

17 Specifically, this committee evaluates for

18 identification and description of the monograph

19 substance, quality standards and purity of the

20 starting material, manufacturing process and

21 process controls, analytic procedures and

22 reference standards for starting material, storage



110

1 and stability data, toxicology, and the first safe

2 attenuation in humans for OTC and Rx use.

3 The second committee is the

4 Pharmacopoeia Revision Committee. This expert

5 panel is composed of physicians, methodologists,

6 and epidemiologists, with experience using and

7 researching homeopathic medicines. The

8 Pharmacopoeia Revision Committee is responsible

9 for review of the clinical evidence for monograph

10 submission.

11 This committee evaluates the drug's

12 potential usefulness by examining its homeopathic

13 proving, which is a human experimental

14 investigation into the clinical properties of the

15 homeopathic drug. The Pharmacopoeia Revision

16 Committee specifically evaluates a submitted

17 monograph and the homeopathic proving for

18 qualifications of the investigators, prior

19 information on the investigational substance,

20 study design and methodology, data collection and

21 record keeping, safety assurance, informed consent

22 process, ethical and legal compliance, and



111

1 analysis of the study results.

2 The primary objectives of these two

3 evaluations is to establish the identity of the

4 new medicine under consideration, ensure the

5 quality standards are present for the manufacturer

6 of the new medicine, establish levels of safe use

7 in humans, and establish if the new medicine has

8 appropriate homeopathic utility.

9 Like our counterparts at USP, the

10 monograph review process does not establish a

11 labeling indication for any given homeopathic

12 medicine. Such indications are established using

13 the results of homeopathic provings, clinical

14 reports, historical literature, and other

15 investigational studies, all in accordance with

16 the requirements of the CPG.

17 The HPCUS Board of Directors conducts a

18 final assessment of the monograph submission,

19 based on the safety, identification, and

20 manufacturing quality evaluations of the Monograph

21 Review Committee and upon the methodology and

22 clinical data evaluation of the Pharmacopoeia



112

1 Revision Committee.

2 The Board may recommend approval of the

3 monograph based on submitted data or it may return

4 it to the sponsor due to the need for additional

5 evidence. HPCUS' review committees are committed

6 to consistent scientific rigor in the process of

7 monograph review.

8 As you would expect, a great deal of

9 attention is paid to methodology and safety

10 assurances. Most of the reviews require multiple

11 meetings. Additional clarifications are often

12 sought from the sponsor to ensure completeness and

13 adherence to the requirements.

14 In the past five years, the HPUS

15 monograph review process underwent a systematic

16 review and update. This review focused on

17 ensuring that the current guidelines are

18 harmonized with ICH guidance for GMP, FDA guidance

19 on human testing, and other relevant guidance

20 within the homeopathic and conventional scientific

21 literature.

22 This updating of the monograph review



113

1 process has had two specific results. First,

2 these updates have helped improve the quality and

3 breadth of data submitted by the monograph

4 sponsors, which has aided in the review process.

5 Second, these updates have provided the

6 greater homeopathic community with model guidance

7 for monograph evaluation, nearly all of which has

8 been adapted by both the European Commission on

9 Homeopathy, and the International League for

10 Homeopathic Medicine.

11 So now, I'll hand this back to Dr.

12 Borneman for some concluding remarks. J.P.

13 Borneman

14 DR. BORNEMAN: Thank you, Dr. Hoover.

15 From the HPCUS perspective, the existing

16 regulatory framework in the Compliance Policy

17 Guide 400.400, promulgated in the 1980s, functions

18 by and large very well. The Homeopathic

19 Pharmacopoeia provides complete monographs for

20 official homeopathic drugs and manufacturing

21 quality and safety standards that are clear,

22 accessible, and under continual review.



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1 The combination of the HPUS and the

2 Compliance Policy Guide provides explicit guidance

3 for the user. The CPG is precise about the origin

4 and justification of drug claims in the

5 homeopathic literature, and calls for all marketed

6 products to comply with all other applicable

7 sections of 21 CFR and the Act.

8 The CPG is silent however on a bright

9 line between claims appropriate for drugs marketed

10 OTC and those requiring a prescription. This is

11 particularly problematic in the field of

12 homeopathy where the literature deals with

13 symptoms, not necessarily syndromes or conditions,

14 and many times, symptom descriptors are very

15 precise.

16 For example, dry cough versus barking

17 cough versus bronchial cough. This language

18 precision makes it particularly difficult for the

19 regulator. It also can be difficult for the

20 marketer, since the OTC status of a claim will

21 necessarily vary by these descriptive terms. From

22 the HPCUS perspective, this is an area of the CPG



115

1 that might require future thought, but it may not

2 require revisions with better training on the CPG

3 by the Agency.

4 HPCUS wants to emphasize, and in concert

5 with the CPG, that it is essential that

6 homeopathic medicines be clearly identified as

7 such on the principle display panel, and that it

8 must be made clear to consumers that their

9 medications are indeed homeopathic.

10 The effectiveness of the Compliance

11 Policy Guide can be enhanced without substantive

12 changes to language by using more effective

13 communication. I was privileged as a young man to

14 observe the discussions that resulted in the CPG,

15 between the Agency and the homeopathic community

16 in the mid-1980s. Yes, I am old.

17 The homeopathic community brought the

18 matter to the Agency, acknowledging that more

19 structure would be beneficial to both groups. The

20 dialogue was noteworthy for its probity and its

21 comity. The outcome was not only an effective

22 regulatory framework, but enhanced relationships



116

1 built by FDA staff and leaders in the community.

2 As the CPG was implemented, it was these

3 relationships that were a key to its efficacy.

4 When the Agency had questions, needed

5 clarifications, or access to information, they

6 called the leaders at HPCUS. When industry saw

7 bad actors or needed clarifications, the American

8 Association of Homeopathic Pharmacists called the

9 Agency.

10 The model went on for nearly a decade,

11 again, based on those early relationships. It was

12 efficient and it was effective. Our hope is that

13 a result of this hearing may be to restart such a

14 model where the HPCUS can offer to do things for

15 the Agency.

16 The HPCUS, as an example, can offer to

17 conduct seminars for the Agency and make its

18 experts available as an information resource.

19 Indeed, we may have already begun. Within the

20 last week or so, HPCUS has received an invitation

21 from the Drug Information staff at FDA to provide

22 a seminar on how the HPUS is used.



117

1 Representatives from the compendial

2 operations staff at CDER have made helpful

3 comments on the guidelines for homeopathic

4 manufacturing that is currently slated for

5 implementation in 2017. And CDER staff joined the

6 HPCUS annual meeting on April the 12th. HPCUS

7 welcomes this interaction with the Agency and is

8 pleased to become a resource to the FDA in support

9 of the Compliance Policy Guide.

10 HPUS is justifiably proud of its

11 accomplishments over the past two-and-one-half

12 decades and appreciates and enjoys the support of

13 the FDA, but the FDA has shown it. We look

14 forward to a continued successful collaboration

15 and we welcome your questions this afternoon.

16 DR. WHYTE: Gentlemen, thank you for

17 that great historical perspective. Mr. YingLing,

18 it's great to hear that you were involved in this

19 30 years ago or more, and you're not worn out by

20 it and are still in it today. So welcome. So

21 I'll allow the panelists to decide if they want to

22 direct their question to a specific person or



118

1 allow all of you to decide collectively who wants

2 to answer it. We have a lot of questions and we

3 only do have five minutes, so I'll start with

4 Rima.

5 DR. IZEM: Thank you. Thank you so much

6 for the presentation. I have a question about the

7 level of evidence that you require for the data to

8 go on the monograph, specifically for safety. So,

9 for instance, do you require experiments or

10 observational data? Does it have to be published

11 in a peer-reviewed journal? Does the evidence

12 have to be replicated? So what's the level of

13 evidence for --

14 DR. BORNEMAN: The level of evidence for

15 safety in the pharmacopoeia follows a process that

16 has been set up by the Toxicology and Safety

17 Committee. Generally speaking, it refers to the

18 accidental ingestion in a 10 kilogram child. So

19 using null data that's available or other

20 published data, we're able to go out and determine

21 what the null effect would be or the null level

22 would be for a 10 kilogram child and then we add



119

1 two orders of magnitude to that.

2 So if it's a tenth of the gram, we would

3 come out at 3X. Many companies add an order of

4 magnitude or two on top of that, particularly if

5 it's for pediatrics. So we're looking at

6 somewhere in the neighborhood of three orders of

7 magnitude before it hits OTC. But it's published

8 literature in general that we look at.

9 MS. LIPPMANN: Forgive me, I don't

10 remember whose slide this was, but similar kind of

11 questioning. You say that the primary evaluation

12 tasks are safety and potential usefulness. Can

13 you clarify is potential usefulness different from

14 efficacy?

15 DR. HOOVER: Yes. So potential

16 usefulness indicates that as a result of approving

17 there are indications that a clinician who's

18 homeopathically trained can recognize that this

19 medicine could be used in a specific type of

20 patient.

21 Remember that we're not driving towards

22 diagnostic categories in approving, similar to



120

1 what a drug trial would do. We're driving towards

2 individual specifications for that substance. So

3 I guess another way to look at it would be similar

4 to the way that Dr. Borneman described it.

5 So for a cough, might be an indication

6 or you could think of it as a diagnostic category,

7 or strep throat might be a diagnostic category.

8 But within homeopathic medicine, we think of

9 diagnosis more in terms of the remedy that's

10 selected, or the medicine that's selected for a

11 given patients.

12 So the proving results in an identity

13 for the medicine that can be described accurately

14 and consistently by a group of physicians who use

15 homeopathic medicines. So they're able to say,

16 all right. This medicine will be useful in this

17 situation.

18 Efficacy, as Dr. Jonas described earlier

19 is generally established for a single indication

20 for a single substance and typically will use

21 double-blind, placebo-controlled trials or

22 effectiveness kind of data research, which will



121

1 take a longer period of time. Indications, as

2 we've mentioned before, are really the

3 responsibility of the manufacturer to establish,

4 based upon literature, testing that might be

5 available, or in journals, et cetera.

6 MS. LIPPMANN: So leads me to my next

7 question which is a question I've asked other

8 presenters as well. What is it about the FDA's

9 process of establishing efficacy through the gold

10 standard, placebo-controlled, randomized clinical

11 trials, what about that is inconsistent with

12 homeopathic remedies?

13 DR. HOOVER: There's nothing

14 inconsistent. Impractical might be a better word.

15 MS. LIPPMANN: The practicality issue as

16 opposed to it wouldn't work for homeopathy?

17 DR. HOOVER: As one of the earlier

18 people described, it's a difficult process. It

19 can be done. The selection process and inclusion

20 criteria that would be required might require a

21 large population selection in order to find people

22 who fit that particular remedy perfectly in order



122

1 to demonstrate its effectiveness for a given

2 claim.

3 MS. LIPPMANN: So it's not that you feel

4 that those kinds of trials would not be possible

5 with homeopathic remedies specifically.

6 DR. HOOVER: It's certainly possible.

7 MS. LIPPMANN: Okay. I don't want to hog

8 my time. I'm sorry.

9 DR. LOSTRITTO: In the interest of time,

10 I'll bullet down my question to as narrow a case

11 as possible. In your projected upcoming revision

12 on manufacturing and controls for homeopathic

13 products, could you please highlight for me three

14 key things that that's going to cover that weren't

15 covered before in terms of either process

16 understanding, specification setting, or shelf

17 life setting, something along those lines. Just

18 some key high points please.

19 DR. BORNEMAN: Okay. You're asking me

20 to boil four years' worth of work into three

21 sentences, but I will try this, Dr. Lostritto.

22 Okay, so first off, the way -- what was called



123

1 general pharmacy was difficult to navigate. So

2 the first thing we did was create a hyperlinked

3 version so that people could move fluidly from one

4 section to another.

5 We clarified the drug classes. We

6 clarified some information around the routes of

7 administration. You asked us specific on -- that

8 section does not speak to the quality control

9 standards or the specifications for raw materials

10 or for first potencies called mother tinctures,

11 but that was also updated in the parallel document

12 that was created by the Standards and Controls

13 Group. So they were parallel tracks.

14 So what's happening is standards and

15 controls is building the specifications data. Our

16 counsel in pharmacy, which does pharmaceutics, is

17 actually looking at the implementation of that.

18 Hopefully, at the end of the day, it's a document

19 that's clear enough for the Agency to regulate

20 against it, and the manufacturers, more

21 importantly, to be able to use it effectively.

22 DR. MICHELE: So thank you for that



124

1 presentation. I already have permission to ask

2 difficult questions, but I'll try to pick one

3 that's not so difficult. I noted that you said

4 that you have added nine ingredients in the past

5 10 years or so. Could you comment on the criteria

6 that you use to identify that a new ingredient is

7 appropriate for your monograph?

8 DR. BORNEMAN: Thank you, Dr. Michele.

9 We structured this program around that question.

10 So the material that Dr. Hoover covered really

11 walks through the process that we're using to

12 evaluate these so-called new monographs. And one

13 needs to remember that even though they are new to

14 us, they're in clinical use elsewhere already. So

15 there's a body of clinical data already associated

16 with them.

17 Prior to that, the monographs that we

18 did were descriptive monographs for substances

19 that were either in prior versions of the

20 pharmacopoeia that needed to be completed or were

21 already in clinical use in the United States. So

22 I can let -- if you have specific questions about



125

1 it, I think Dr. Hoover can walk back through that

2 process.

3 But the process that we talked about,

4 the monograph review, pharmacopoeia revision

5 process, is sort of a high level outline of that

6 approach.

7 DR. WHYTE: Dr. Nelson?

8 DR. NELSON: Yeah, a quick question.

9 Your comment -- changes would be such that the FDA

10 could regulate against it. My question is, as a

11 process issue, what confidence would you be able

12 to place around the process of creating this

13 document that in fact FDA could in fact regulate

14 against something that is not within their

15 control? Because in other areas that has

16 generally led to a fair degree of nervousness

17 within the Agency.

18 DR. BORNEMAN: I'm not sure I exactly

19 understand the question, so let me repeat it back

20 to you. Are you asking why we think that the

21 guidelines for homeopathic manufacturing are able

22 to be the foundation for regulation?



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1 DR. NELSON: No. What confidence in the

2 -- in other words, even if one could agree today,

3 and I'm not, you know, it's not my place to agree

4 that it would be appropriate standard to regulate

5 against, you all go away, we all go away, 30 years

6 from now, who knows who's in charge, what the

7 process is. You're basically saying the FDA ought

8 to place its confidence in you, an external party,

9 to create something that it uses as the standard

10 to regulate. So what confidence in your process,

11 not in this standard --

12 DR. BORNEMAN: I understand.

13 DR. NELSON: -- in your process that

14 would speak to the -- or what would you put in

15 place --

16 DR. BORNEMAN: So I think there's

17 probably two things that we need to say, Dr.

18 Nelson, and thank you for the question. The first

19 is we have a statutory requirement, just like USP.

20 So whether we go away or not, the pharmacopoeia is

21 in the statute, okay? So that's the first aspect.

22 The second is that the processes and



127

1 procedures at HPUS have been developed in a very

2 intensive way over the last decade and are

3 available for anyone's inspection. We have a

4 procedure manual that's clear and we follow the

5 processes in our procedures manual, ala EPA if you

6 will. So you know I think that our internal

7 processes and procedures are something that we

8 take very seriously and that were this generation

9 to move to the next, that those processes and

10 procedures would be clear and able to be

11 implemented.

12 DR. WHYTE: (Off mic).

13 DR. BORNEMAN: Sure.

14 DR. WHYTE: Mr. Pace?

15 MR. PACE: How can FDA better determine

16 that a product is being offered for use or

17 promoted significantly beyond recognized or

18 customary practices of homeopathy, and could the

19 HPUS be clear with that respect, and I guess what

20 are your thoughts on the idea of what is generally

21 recognized as a homeopathic ingredient if it is

22 not in the HPUS?



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1 DR. BORNEMAN: The HPUS' statutory

2 authority is limited to setting standards. We are

3 not in the indications business. The CPG is what,

4 in our view, obtains, when it relates to

5 indications for use. And one of the things that I

6 mentioned in my remarks was that the OTC Rx line

7 is not very bright sometimes when it relates to

8 homeopathic parlance.

9 So at the margins, I am personally

10 speaking for myself, don't believe that it's too

11 hard to figure out something that's clearly Rx or

12 something that's clearly OTC. The area of

13 conversation is where those intersect and where

14 rational people could disagree with one another.

15 I think that's really the area. And

16 frankly, I don't think that that area is very

17 large. But it really has to do with not the

18 homeopathic part of it. It has to do with the OTC

19 part of it. And the criteria for OTC don't vary

20 whether it's homeopathic or allopathic. They're

21 the same. So from a regulator perspective, and

22 again, speaking for myself, I think that it really



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1 has to do with the Rx OTC designation generally

2 that becomes problematic.

3 Things that are clearly outliers are not

4 hard to figure out. It's the ones that are in the

5 interse (ph) disease that are difficult.

6 DR. WHYTE: Thank you, gentlemen. And

7 at that this time, I want to invite Al Lorman,

8 from the law office of Alvin J. Lorman to the

9 podium. Al Lorman

10 MR. LORMAN: Good morning. I appreciate

11 the opportunity to speak to you today. My name is

12 Al Lorman and I have been a food and drug lawyer

13 for 38 years. I am even older than Jay (ph)

14 Borneman. And I have represented in those 38

15 years, clients who have been involved in all

16 aspects of FDA's substantive responsibility.

17 Among my clients are a number of

18 homeopathic drug companies, as well as the

19 industry trade association, the American

20 Association of Homeopathic Pharmacists, and I also

21 provide advice on occasion to the Homeopathic

22 Pharmacopoeia. Because of these relationships, I



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1 have spent many years thinking about the subject

2 of this hearing.

3 Just as to a hammer, everything looks

4 like a nail. To me, I look at these things and I

5 see legal and public policy issues, and it's from

6 that perspective that I want to speak to you

7 today. While most of my clients likely agree with

8 what I'm going to say, I do want to emphasize that

9 my remarks are my own, and if I offend anyone,

10 please be angry at me and not my clients.

11 I asked for time to speak today, because

12 to steal a phrase, I was present at the creation

13 of the current Compliance Policy Guide, because I

14 represented the industry group that initiated the

15 discussions with the Agency and I was involved

16 with every discussion with the Agency that took

17 place with outside parties.

18 Prior to the issuance of the CPG in

19 1988, FDA followed a very different CPG, one which

20 asserted that all homeopathic drugs were in fact

21 prescription only, based on the particularization

22 that you've heard physicians describe. That



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1 position was substantially tempered by the fact

2 that the Agency didn't actually enforce it very

3 often and never actually against domestic

4 manufacturers of homeopathic products.

5 It did, however, episodically enforce

6 the Rx rule against imported products. An

7 industry coalition met with the Agency and noted,

8 among other issues, that the Agency's enforcement

9 against imported products only, probably violated

10 U.S. trade treaty obligations. At the same time,

11 the Agency, in language that is remarkably similar

12 to that used in the Federal Register notice

13 announcing this hearing, said that homeopathy was

14 growing and that it was to re-examine how it was

15 regulated.

16 That initial meeting led to a series of

17 discussions, which resulted in the issuance of the

18 current Compliance Policy Guide in 1988. One

19 immediate impact of the issuance of the CPG was

20 the establishment, as described by others, of a

21 very cooperative working relationship between the

22 Agency and the industry.



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1 When the CPG was adopted, it was seen as

2 very much a win-win situation for both sides, as

3 well as for consumers. When the Agency had

4 questions about the propriety of certain claims or

5 certain delivery systems, it could and did pick up

6 a phone and ask. And industry took advantage of

7 that relationship to file trade complaints against

8 companies that did not follow the requirements of

9 the CPG, with some hope of Agency action in

10 response.

11 That cooperative approach lasted about

12 15 years, but is sadly no longer the case. I hope

13 that this hearing is the start of a reinvigoration

14 of that cooperative relationship, which I believe

15 was helpful to the Agency, to the consumers, and

16 to the industry as well.

17 FDA's stated reasons for this hearing

18 involved what it called the explosive growth in

19 the market for homeopathic drugs and some

20 purported safety concerns. I believe that the

21 claimed safety issues are not real and have been

22 adequately addressed by others.



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1 Similarly, the explosive growth that

2 seems to trouble the Agency, is based upon numbers

3 that the homeopathic manufacturers can only dream

4 about. In fact, the market seems to be about one-

5 third of what FDA sets it at. If you'd care to

6 let us know where the other $2 billion are, we'd

7 be happy to note that down.

8 So if -- I ask if things haven't really

9 changed that much, and I don't think they have,

10 why are spending the time and energy to consider

11 any substantial revision to the Compliance Policy

12 Guide? That FDA calls homeopathic drugs,

13 unapproved new drugs, sounds scary. But actually

14 puts homeopathic drugs into excellent company.

15 According to the Agency, there are several

16 thousand unapproved prescription drugs still in

17 the market today and many, many OTC drugs,

18 allopathic OTC drugs, are not subject to final

19 monographs, and so therefore are also technically

20 unapproved new drugs.

21 The real issue is not whether

22 homeopathic drugs are unapproved new drugs, which



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1 is the statutory term of art, but rather the

2 process that the Agency must engage in for a

3 binding determination of their legal status. That

4 issue goes back to 1962 when Congress adopted the

5 drug amendments of '62, which for the first time

6 added the efficacy requirement to the new drug

7 approval process.

8 Faced with examining thousands of pre-

9 1962 drugs, FDA first reviewed prescription drugs

10 through a contract with National Academy of

11 Sciences National Research Council. Over 50 years

12 later, that review is still ongoing if not

13 moribund with those several thousand drugs that I

14 mentioned, never fully upgraded as safe and

15 effective nor removed from the market.

16 When FDA turned to examining OTC drugs

17 for efficacy under the '62 amendments, it decided

18 to take a different approach. Rather than review

19 drugs individually as it had done in the DESI

20 review, it decided to review them by therapeutic

21 category. In announcing the OTC review in the

22 Federal Register in '72, FDA said that it was



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1 taking this therapeutic category approach for

2 several reasons.

3 One, the Agency's limited resources

4 would be overwhelmed trying to review each OTC

5 drug individually. Two, litigation to remove

6 violative drugs would have to be on a case-by-case

7 basis, another enormously research intensive

8 approach.

9 And finally, litigation concerning the

10 scope of the 1938 and 1962 grandfather clauses

11 would more than exhaust all present resources of

12 the Agency, the latter being quote (sic).

13 As noted by the Agency in the Federal

14 Register notice announcing this hearing and as

15 remarked on many times today, OTC drugs were

16 excluded from the OTC review and were supposed to

17 have been the subject of a separate review to

18 follow the completion of the OTC review.

19 The OTC review is far from over and we

20 have little reason to expect that an OTC review of

21 homeopathic drugs is anywhere on the horizon. In

22 the absence of a homeopathic OTC review, it is



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1 fair to ask what changes, if any, to the current

2 Compliance Policy Guide would both advance the

3 public health while not taking a disproportionate

4 investment of Agency resources.

5 I believe that the data that have been

6 and will be presented at this hearing, show that

7 homeopathic drugs are extremely safe, just as they

8 were found to be in 1988. Given the low levels of

9 active ingredients present in these products, that

10 is not surprising.

11 So the real question, seems to me, is

12 how time and energy the Agency is willing to

13 commit to reviewing homeopathic drugs. As the

14 Agency recognized in 1972 in adopting the OTC

15 review procedures, the Food and Drug Act does not

16 empower you wave a magic wand and remove drugs

17 from market, although I'm sure you would be happy

18 to have such a wand.

19 In view of the very low incidence of

20 serious adverse events associated with homeopathic

21 drugs, it is difficult to see how the public

22 health would benefit from a significant investment



137

1 of Agency resources in the creation and

2 implementation of a new regulatory approach.

3 I believe that the risk benefit calculus

4 that the Agency adopted in 1988 is essentially

5 unchanged today. The Federal Register notice for

6 this hearing raised the issue of OTC homeopathic

7 drugs carrying what the Agency considers to be Rx

8 claims, and asked about an appropriate review

9 process.

10 The supposed Rx claims I believe fall

11 into three different categories. The first

12 category consists of claims which FDA and almost

13 everyone in industry would actually agree are Rx.

14 Most of these claims are made by companies which I

15 believe to be outliers to the homeopathic

16 industry.

17 Most of these companies do their

18 marketing on the Internet and they have very

19 little history in the homeopathic community. And

20 most of these products seem to disappear when the

21 manufacturers receive warning letters from the

22 Agency.



138

1 The second category consists of what I

2 believe to be a very small number of claims which

3 the Agency considers Rx, but which are claims upon

4 which reasonable people could differ. Warning

5 letters citing these claims usually prompt a

6 detailed and documented response from the

7 manufacturer. Again, this is, to my mind, a very

8 small universe.

9 The third category of claims the Agency

10 considers Rx, are based more upon the differences

11 between allopathic and homeopathic drugs, than

12 upon the need for any actual physician

13 intervention. Since homeopathy is traditionally a

14 symptom-based approach, it uses words which are

15 not generally used on allopathic labels.

16 Those terms sometimes show up in the

17 purposes section of the drug facts panel, as well

18 as on the indications for single ingredient

19 products. These allegedly Rx claims, and I'm

20 citing Agency warning letters now, include words

21 such as bleeding, inflammation, burning runny

22 nose, and gum disease.



139

1 In addition to objecting to these, to my

2 mind, fairly ordinary English words, some FDA

3 compliance personnel have taken the position that

4 no indication which does not appear in the OTC

5 review can be used on a homeopathic product label.

6 I suggest that is simply not the law.

7 The Agency asked whether there is

8 information regarding the regulation of

9 homeopathic drugs in other countries that can

10 inform FDA's consideration. You've heard from

11 Health Canada. I understand the trade association

12 is going to submit written comments.

13 The one thing I would like to point out

14 is that to the best of my knowledge, regardless of

15 the system used in any other country, even those

16 which require a form of premarket approval, the

17 efficacy of homeopathic drugs is inevitably based

18 upon the literature. If that is the case, one may

19 ask how that any of those systems are an advance

20 over the current CPG approach.

21 Finally, the Agency asked about areas

22 where the current CPG could benefit from



140

1 additional clarity. There has been a lot of

2 discussion about products containing homeopathic

3 actives and diet supplements. I believe that that

4 clearly needs to be clarified. When the CPG was

5 adopted in 1988, the prohibition against drug

6 products containing homeopathic ingredients in

7 combination with non-homeopathic active

8 ingredients was clearly understood to cover the

9 combination of homeopathic and allopathic active

10 ingredients.

11 I don't believe that anybody in the

12 mainstream industry has any objection to that

13 interpretation. In fact, the only non-homeopathic

14 active ingredient that could be covered by that

15 sentence is an allopathic drug, because the

16 discussion about combining homeopathics with diet

17 supplements is actually a discussion about

18 combining homeopathic active ingredients with a

19 food.

20 So I don't believe that it was intended

21 in '88 to bar the combination of homeopathic

22 actives and diet supplements. There is clearly a



141

1 lot of discussion about the appropriateness of

2 that. My suggestion is that the Agency clarify

3 the language on that point in the CPG, so that

4 industry knows exactly what is and is not

5 permitted.

6 Another issue that has been raised in

7 questions a lot is how does the Agency know

8 whether something is appropriately homeopathic,

9 when it is a new active, and therefore not in the

10 homeopathic pharmacopoeia. That actually was the

11 subject of a lot of discussion at the time of the

12 drafting of the Compliance Policy Guide.

13 I confess that it's probably not the

14 most artfully worded part of the Compliance Policy

15 Guide, but in fact, the thought at the time was

16 that in fact, when a product is not in the

17 homeopathic pharmacopoeia, the burden of proof

18 shifts to the manufacturer to essentially

19 demonstrate to the Agency that the product is

20 generally recognized as homeopathic.

21 Now how do you initiate that process?

22 The Agency does that it seems to me in warning



142

1 letters. It could, if it chose not to issue a

2 warning letter, simply ask a manufacturer. No one

3 has ever debated that that is the burden of the

4 manufacturer to demonstrate that the product is

5 appropriately homeopathic, if you ask. So the

6 real question is how do you go about asking?

7 Finally, there is another change that I

8 suggest and that is yesterday you heard the

9 American Association of Homeopathic Pharmacists

10 explain that it had adopted a disclaimer for

11 advertising and labeling, so that consumers are

12 aware that these products are somehow different,

13 modelled on diet supplements. It's that these

14 statements have not been reviewed by the Food and

15 Drug Administration.

16 I believe that's important information

17 for consumers to have and I believe that it would

18 be appropriate for the Compliance Policy Guide to

19 require all parties making homeopathic drugs to

20 include that statement. Thank you very much for

21 the opportunity to speak to you today.

22 DR. WHYTE: Thank you, Mr. Lorman.



143

1 We'll have five minutes of questions and we'll

2 start with Richard.

3 DR. LOSTRITTO: Thank you for addressing

4 some of the previous comments. Appreciate that.

5 You said something that sparked a thought in my

6 mind in that some of your discussion implies that

7 maybe the template for the drug facts

8 representation isn't ideally suited to homeopathic

9 products. Could you address that, what your

10 feelings are about that? Do they need to be

11 updated, changed --

12 MR. LORMAN: You've asked me whether the

13 drug facts panel is ideally suited. I actually

14 don't think it's ideally suited, and in fact the

15 Agency has in guidance exempted homeopathic drugs

16 from using the drug facts panel. Much of the

17 industry in the interest of providing consumers

18 with additional information have voluntarily

19 adopted the drug facts panel.

20 The problem is that in the drug facts

21 panel, the section that deals with active

22 ingredients, there's a purposes section.



144

1 Homeopathic drugs don't have the same kind of

2 purposes as allopathic drugs, such as

3 antihistamine or anticholinergic or whatever, so

4 they had to come up with something to say, and

5 frankly the industry, many members of the

6 industry, have tried to use the purposes section

7 as an educational tool to tell consumers what that

8 particular ingredient does. Do I personally think

9 it's the perfect setup for a homeopathic drug

10 label? I don't.

11 DR. LOSTRITTO: Thank you.


13 MR. LORMAN: Thank you.

14 DR. WHYTE: Our final speaker before

15 lunch will be Terry Cotter from Terra Medica Inc.

16 MR. COTTER: Terra Medica.

17 DR. WHYTE: Terra Medica.

18 MR. COTTER: Small but --

19 DR. WHYTE: Powerful. Terry Cotter

20 MR. COTTER: Oh yeah, absolutely. Good

21 afternoon, panel. Thank you very much for the

22 invitation to speak today. It's a short



145

1 presentation of course and I have more

2 supplemental notes you probably have received.

3 I'm representative of Terra Medica. We're a

4 professional product manufacturer. Actually, not

5 manufacturer; we distribute on behalf of

6 manufacturers in Germany and Switzerland.

7 My background personally does include

8 public policy development and I respect the

9 process that we're undertaking here today. I want

10 to talk about consultation within the working

11 culture of regulation and how it deploys in the

12 field and how manufacturers like us deal with

13 these issues.

14 Terra Medica represents the Pleo Sanum

15 homeopathic products from Germany. They've been

16 sold worldwide for about 40 years and in North

17 America for about 25, entirely without incident

18 globally. The manufacturer has been compliant

19 with their local GMP oversight by the German Trade

20 Supervisory Board or TSB there, since the new

21 programs were implemented in

22 2004.



146

1 We import about $1.5 million of product

2 from that manufacturer to the United States.

3 We're a pretty small player, but in all that time

4 we haven't had any difficulties with incidents.

5 In March 2013, the FDA sent a two-person GMP audit

6 team to the manufacturing facilities in Germany.

7 The auditors spent seven intensive days

8 on that site. And I, among many others, I guess

9 we look at the -- try to understand the deployment

10 of public resources to remote inspections and

11 reviews like this, as we give consideration to

12 public investment in resolving public safety risks

13 and I think we've seen a pretty low bar in that

14 risk threshold established here in these hearings.

15 In this particular case, the FDA didn't

16 notify the local German TSB authority that they

17 were going to perform an audit, and they didn't

18 provide any post audit results to that authority.

19 A year after the audit, the FDA issued an

20 unexpected and surprising announcement of a new

21 theoretical risk of antibiotic contamination.

22 Neither the GMP authority or the



147

1 manufacturer were consulted about the intellectual

2 property processes that actually prevent this

3 theoretical risk. FDA rejected an appeal from the

4 manufacturer to present a science dossier to

5 explain the details of why this theoretical risk

6 really didn't exist.

7 And we, at Terra Medica, were then

8 immediately encouraged to conduct a voluntary

9 recall in 2014. And all of these despite zero

10 incidents worldwide of any contamination. FDA

11 also issued a press release about the theoretical

12 risk to global health authorities and provoked

13 international confusion for the German

14 authorities.

15 Most important to this proceeding I

16 think, is that the press release really encouraged

17 corporate media to start printing flippant,

18 generalized headlines about contaminated

19 homeopathic products generally and we've endured -

20 - I've seen these for the last year.

21 Many of those articles are still on the

22 web. It seems corporate writers have taken this as



148

1 license to write general complaints about

2 homeopathics and being contaminated, et cetera.

3 This international incident motivated the German

4 regulator to conduct a new site inspection, and in

5 December, they reported to the FDA the products

6 continue to be safe and contamination is not, in

7 fact, a risk.

8 The German GMP authority continues to

9 wait for any response from FDA, and you can

10 imagine that we are waiting as well. The medical

11 community here in North America has been in shock

12 and Terra Medica products which have, again been

13 available for some 25 years here, I'm getting

14 calls daily from doctors and patients desperate to

15 resume their treatment programs.

16 I have another example about

17 consultation and this one is related to Swiss

18 RhuMed(ph) products. This product line is locally

19 produced in Switzerland under GMP inspection.

20 Again they're a homeopathic, complex homeopathic

21 products, and they've been distributing them

22 globally since 1993, and in North America since



149

1 about 2002, again without any incidence globally.

2 In 2008, the FDA required Terra Medica

3 to consult with the USDA, because one of

4 ingredients in the products is actually a sterile

5 diluted product of animal origin. I read the

6 guidance documents myself and I became convinced

7 that our products were actually exempt from USDA

8 oversight.

9 Six years later while we engage in an

10 annual permitting process, six years later in

11 2014, a shipment was stopped and I had to contact

12 a more senior official for amendment to the papers

13 that they had. The senior official asked me, Is

14 all the product in finished packages? And I said,

15 Yes. Well, your products are exactly exempt from

16 our oversight anyway.

17 In both stories, what I'm trying to

18 relate to you is what I believe is the importance

19 about consultation. I'm hoping that this process

20 is proactive. It's been rather passive, I would

21 say so far, in that the invitation was extended to

22 community, but certainly we have here many



150

1 professionals with significant experiences in

2 these areas to give you more direct responses to

3 specific questions and I encourage that to unfold.

4 That's the reason for me bringing this

5 story here today. It's not about complaints about

6 service at all. It's about concern for the

7 regulatory oversight, but also the industry

8 stewardship aspect. If the bars are set too high

9 and well beyond a reasonable expectation of public

10 safety, then what you're jeopardizing is the

11 opportunity for industry to continue to be

12 innovative.

13 And I think it's very instructive as I

14 listened to the previous presenters speaking about

15 nine monographs added to the US, HPUS, in the past

16 10 years. Most of the innovation connected to

17 this improving and expanding, I mean I go to

18 events around the world, there are tremendous

19 things happening in the integrated medicine field.

20 Homeopathy isn't an island and unto itself, it

21 works with many other tools in conventional

22 medicines, but other therapeutic interventions as



151

1 well.

2 So all I'm saying is try for the good of

3 the North American industrial community, try and

4 keep the bar relative to the actual safety risk

5 and allow the industry to continue to innovate.

6 Thank you very much.

7 DR. WHYTE: Thank you, Mr. Cotter. Do

8 we have any questions? Okay. Well thank you.

9 MR. COTTER: Thank you. Lunch time.

10 DR. WHYTE: That's for me to say, Mr.

11 Cotter. Well, it is now -- let's check all of our

12 watches. It is basically 12:05, right on time.

13 We will take an hour lunch and we will resume here

14 promptly at 1:05. Thank you.

15 (A lunch recess was taken.)

16 DR. WHYTE: Is Dr. Chung still here from

17 Northwestern? Okay. We're going to get started

18 in another minute. A couple folks have asked for

19 us to give the email address, as well as the post

20 office address of where to send comments, so I'm

21 going to leave that on for another minute or so,

22 so folks can jot that down. Remember you have



152

1 until June 22nd to send any additional comments

2 that you would like us to consider.

3 I do want to acknowledge that during the

4 last session we actually had some audio difficulty

5 on the webcast. I don't know if any of you heard

6 it. Or if, let me see who it was -- was it -- Mr.

7 Mittman's mother might not have heard the happy

8 birthday. I don't know. So we have to find out.

9 But we did have some audio difficulty only for a

10 few minutes. So I apologize to any of those

11 speakers who we may not have gotten your audio

12 comments.

13 But we do have a transcription, as I

14 noted at the beginning, which will be posted to

15 the site. So I assure you that your comments will

16 still be considered as part of the process, even

17 though as part of the webcast that it was not

18 captured. I do recognize that there are some

19 other people filming. I'll let all of you decide

20 how you want to manage that.

21 So we're back on time and we'll start

22 the afternoon session with Mr. Edgar Pergament



153

1 from Materia Medica Holding. Edgar D. Pergament

2 MR. PERGAMENT: Good afternoon. My name

3 is Edgar Pergament. I am a partner with the firm

4 of Pergament Gilman & Cepeda. I represent Materia

5 Medica Holdings and with me is Dr. Oleg Epstein,

6 Chairman and CEO of Materia Medica, a Russian

7 biopharmaceutical company. It's basically his

8 presentation, which I translated into English.

9 Materia Medica started its history by

10 producing ordinary homeopathic medicine. However,

11 we change our course. Twenty years ago we started

12 a series of experimental studies would change our

13 understanding of homeopathy and led to the

14 creation of completely new course of medicine.

15 We demonstrated that the potentiated

16 preparation always modifies the properties and

17 activity of the substance from which it is

18 prepared. When using such drug as Aspirin,

19 prednisone, haloperidol, morphine, and

20 cyclophosphan, we observed enhanced

21 pharmacological activity with combined use of

22 standard doses of the drug in homeopathic forms of



154

1 the drug, and in certain cases a decrease in

2 toxicity.

3 For instance, the combined use of

4 diclofenac sodium salt at a standard dose and in

5 potentiated form exhibit a profound anti-

6 inflammatory activity in the in vivo model of

7 Carrageenan-induced edema. And this activity is

8 attributed to a more pronounced inhibitory effect

9 of diclofenac sodium salt in combination on COX.

10 This phenomenon demonstrated to us that

11 a potentiated preparation behaves not as a low

12 dose of the initial substance, as some people

13 think, but as a completely new substance which

14 possesses new properties which the initial

15 substance does not possess.

16 That's we made the first assumption that

17 multiple consecutive reduction in concentration,

18 which is used in homeopathy, leads not to the

19 absolute disappearance of any substance, but to a

20 transition of the initial substance to new super

21 molecular condition, the physical nature of which

22 is yet unknown.



155

1 This modifying effect demonstrated

2 potentiated preparation always has physiological

3 effect on the molecular level even when such

4 effect is difficult to detect. Taking into

5 account the entire homeopathic experience, we then

6 made the second assumption. Namely that for

7 patients who have individual sensitivity to

8 potentiated preparations, the molecular effect,

9 this molecular effect that we observe, is

10 transformed into a clinically significant

11 hyperergic reaction which is used in homeopathy.

12 It is well known that the drug at the

13 standard dose is capable of inducing individual

14 responses of standard type; for example,

15 angioedema, acute anaphylaxis, and non-specific

16 allergic reactions. Apparently, the biological

17 purpose of such reactions is to inhibit

18 interaction between the organism and the molecules

19 for which individual sensitivity is observed.

20 From our point of view, this high

21 dilution contain a super molecular factor, as we

22 said, of yet unknown nature, which is less



156

1 dangerous to the organism, and the organism

2 produces specific response to such factor. A

3 clinical presentation of hyperergic reaction to

4 potentiated dilution is similar to intoxication

5 induced by the same initial substance.

6 In the case of a homeopathic drug, a

7 therapeutic effect could be achieved only when it

8 causes hyperergic reaction. This is an

9 explanation why many placebo-controlled studies of

10 homeopathic medicines don't show efficacy. You

11 need to select patients which are suitable for the

12 study. Therefore, individual homeopathic therapy

13 is impossible without proving, namely clinical

14 investigation of potentiated drug on healthy

15 volunteers.

16 Such an investigation allows the

17 detection of individual responses in some of the

18 volunteers, which are subjected to description and

19 (inaudible) targets for symptomatic use of

20 homeopathic drugs. More importantly, proving can

21 reveal the science of individual hypersensitivity

22 of the respondent to the individual homeopathic



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1 potentiated drugs, phenotypic, constitutional, and

2 (inaudible).

3 Therefore, in our view, it is the use of

4 proving rather than the use of potentiated

5 technology as such is the hallmark of homeopathy.

6 There is an alternative to homeopathic proving in

7 the use of drugs produced using homeopotentiation

8 technology. It is possible to define the

9 therapeutic potential of such drugs by studying

10 the physiological properties using methods of

11 modern pharmacology. In other words, the study is

12 to be conducted on sick patients, rather than the

13 healthy volunteers in classical homeopathy.

14 For ourselves who have chosen this

15 classical pharmacological way, during the

16 experimental study of various biological

17 substances in the form of high dilutions, we

18 establish high efficiency of potentiated

19 polyclonal antibodies and gradually develop a

20 single technological platform for creating

21 potentiated drugs based on antibodies to various

22 molecular antigens: TNF-alpha, interferon, insulin



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1 receptor, cannabinoid receptor, CD4 receptor, NO

2 synthase, and others.

3 We were the first to find that the basis

4 of the molecular effect of any potentiated

5 biological substances is in (inaudible) of

6 sensitizing of the target in the body. The

7 sensitizing effect is consequence of direct

8 influence of the potentiated preparation on the

9 confirmational characteristics of the target,

10 which result in turn in changing the nature of

11 endogenous ligand binding to the target, and in

12 the activation of respective biological pathway.

13 This slide shows our work in NMR

14 spectroscopy. NMR spectroscopy show in the

15 potential, for example, NMR spectroscopy has shown

16 the potentiated dilution of antibodies to

17 interferon gamma induce conformational changes in

18 the molecule in the interferon gamma and

19 interferon gamma receptor, resulting in

20 sensitization of biological targets, alteration of

21 the ligand receptor interaction and activation of

22 interferon pathway.



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1 Potentiated dilution of antibodies to

2 interferon gamma enhance the expression of

3 interferon gamma, as well as interferon alpha beta

4 and interlinking (ph) associated with such

5 interferons, improved ligand interaction between

6 interferon gamma and the specific receptor, and

7 normalized level and function of natural (ph)

8 antibodies to interferon gamma.

9 Does the drug activate the interferon

10 pathway? In effect, the viral (ph) defects of the

11 mechanisms, viral defence mechanism of the

12 organism. We have shown high efficacy and safety

13 of drugs based on potentiated antibodies in

14 hundreds of experiments that have been carried out

15 in the laboratories of 17 countries and in dozens

16 of clinical studies, including double-blind,

17 placebo-controlled studies on sick patients, not

18 on healthy volunteers.

19 A line of our products based on

20 potentiated antibodies have been marketed in

21 Russia and a number of other countries over the

22 last 15 years. Now we want to come to the United



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1 States. Our drugs require a commonly accepted

2 classification and regulatory pathway

3 determination.

4 We consider our drug to be biologics, as

5 they are prepared from biological substances and

6 their pharmacological action is based on the

7 influence on biological targets. With the use

8 spectro and immune assay, we are capable of

9 determining the drug's activity and formulation,

10 express them in unit, including the detection of

11 their specific ability to modify a particular

12 target.

13 We cannot study the pharmacokinetics in

14 the nature that is -- because of the nature of our

15 drugs, we cannot study the pharmacokinetic

16 properties of our products, because the substrate

17 that has the modifying activity is yet physically

18 unknown. This fact should be taken into account

19 in the development regulatory requirement for the

20 new class of drugs we have created.

21 Historically, drugs have been obtained

22 as there is drugs which have been obtained as a



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1 result of multiple concentration degrees defined

2 as potentiated or dynamized drugs. However, in

3 our opinion, such terms are not sufficient to show

4 the genesis of these products.

5 Therefore, we propose the term release

6 active drug that emphasizes that new activity

7 appears as a result of the technological

8 processing of the initial substance.

9 In conclusion, release-active

10 antibodies, which our company have developed, is a

11 novel class of medicinal drugs that needs a

12 regulatory pathway, which would be adequate for

13 their biological and physical features. Thank you

14 very much and Dr. Epstein will answer the question

15 and I will translate.

16 DR. WHYTE: Terrific. Thank you. Let's

17 start with Dr. Nelson.

18 DR. NELSON: Thank you for a complex

19 presentation. I'm not sure I understood all of

20 it, but you did say one thing that I thought was

21 interesting and I'd like to ask more about it. It

22 sounded like you implied that one of the problems



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1 in proving efficacy for your products was that it

2 was being tested on a range of patients, some of

3 whom would not respond, and you suggested that

4 using proving would be some sort of an enrichment

5 strategy.

6 I mean if I understood that correctly,

7 it was the slide where you had the two pictures of

8 the red X and the green one with the proving under

9 it. FDA has guidance on enrichment studies. We

10 talk about that a lot, about how one enriches a

11 population to where it's population that would

12 respond. And so my question is how do you see a

13 connection between a proving and an enrichment

14 strategy in a clinical trial? That connection is

15 not clear to me.

16 DR. PERGAMENT: Okay. I will answer,

17 not Dr. Epstein. I understand your question so I

18 can answer that -- shortly. Our company uses

19 standard pharmacological studies on sick patients

20 to determine the efficacy and safety of our drugs,

21 okay? Proving is the hallmark of homeopathy. We

22 don't consider ourselves homeopathic medicine,



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1 even though we use homeopathic technology in

2 development of our drugs.

3 So there is no room for proving in

4 developing homeopathic antibodies, because they

5 work across the board just like a standard

6 allopathic medicine.

7 DR. WHYTE: All right. Let's go with

8 Dr. Michele.

9 DR. MICHELE: Thank you. That was

10 certainly a very interesting presentation. I,

11 like my colleague, fear that I may not have

12 completely understood everything, but I'll start

13 with the summary where you're taking about

14 release-active antibodies and describing a novel

15 class of drugs that are neither homeopathic, nor

16 allopathic drug products, and I was wondering what

17 your suggestions are to FDA on a pathway by which

18 you think it would be appropriate to regulate

19 these products.

20 MR. PERGAMENT: (translating for Dr.

21 Epstein) Modern pharmacological methods gave us

22 ability to understand what other people couldn't



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1 understand before. The technology that is used in

2 homeopathy, it doesn't dilute the concentration;

3 it changes the substance into a new form of

4 substance. We use biological models which are

5 useful for determining the activity.

6 It was simple for us than homeopathic

7 people, to show that there is always a molecular

8 effect. For this reason, we gave a new system of

9 coordinates for the products. The product that we

10 have, we don't know its nature, but it does have a

11 molecular effect.

12 And we found the substrate antibodies,

13 the molecular effect of which is sufficient to

14 compete with modern biologics if you potentiate

15 the antibodies. In using minerals and herbs, it

16 is difficult to detect the molecular effect, but

17 with antibodies it's -- it matches (inaudible) to

18 detect (inaudible). But the most important thing

19 is not the difficulty of detection, but the

20 practical sense.

21 DR. WHYTE: I'm not going to be able to

22 translate that.



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1 MR. PERGAMENT: Okay.

2 DR. WHYTE: You know what, since we did

3 have the issue with translation time, why don't we

4 go ahead and allow another question if that's okay

5 with you?

6 MR. PERGAMENT: I'd like to answer what

7 he said. The question -- Dr. Epstein went into a

8 little bit different issue. The regulatory

9 pathway for our product is biologics. That's the

10 regulatory pathway we believe should be used for

11 our product.

12 DR. MICHELE: So just to clarify that,

13 you believe that you could run our standard safety

14 and efficacy trials for your products --

15 MR. PERGAMENT: Yes.

16 DR. MICHELE: -- and you would

17 demonstrate safety and efficacy.

18 MR. PERGAMENT: The only thing we don't

19 have is pharmacokinetics. Everything else we can

20 do, just like a standard allopathic biologics.

21 DR. MICHELE: Thank you.

22 MR. PERGAMENT: And we are able to



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1 determine the activity in the tablet, just like an

2 allopathic medicine.

3 DR. WHYTE: Okay, let's -- if you want

4 one more -- okay. Mr. Pergament, did you want to

5 answer one more question?

6 MR. PERGAMENT: Sure.

7 DR. WHYTE: I know there was a little

8 bit of a disadvantage of time. I did not know

9 that it was going to be like the UN General

10 Assembly meeting. And I'm hearing English on one

11 side, Russian on other, I'm getting a headache.

12 Let's go with -- Richard still has his up,

13 although Theresa -- or Judith you had yours up as

14 well. I'll let you guys decide who wants to

15 answer (sic) the question.

16 DR. LOSTRITTO: Very interesting

17 presentation. Many, many questions. I'm just

18 going to ask you -- since you have sort of a hook

19 here that maybe some homeopathic products don't,

20 in that you have the exquisitely specific role of

21 antibodies --

22 MR. PERGAMENT: Yes.



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1 DR. LOSTRITTO: -- interaction with the

2 receptor. I'm going to ask you if you have --

3 what's your next step in terms of showing a

4 mechanism using the hyperergic mechanism you

5 propose here, and things like your two-dimensional

6 NMR and so forth, to try and further elucidate a

7 mechanism to this potentiation effect, which you

8 so far indicate you don't know what it is.

9 MR. PERGAMENT: Okay. I can answer that

10 as well. We have done obviously 15 minutes of the

11 presentation. It is not enough to explain

12 everything we have done. We have done studies

13 with a number of models and a number of analytical

14 methodologies. We have determined that the

15 material that comes out, we have determined

16 experimentally, the materials that comes out at

17 the end of potentiation has biological activity

18 and in some cases has physical activity, okay?

19 Now we're not able to characterize that

20 substance and say what that supramolecular factor

21 is that requires physics and we are not

22 physicists. It's difficult to say. So we don't



168

1 have the next step on that front, because we

2 simply are not -- don't have the -- but we are

3 able, using analytical methodology to detect it,

4 by detecting its effects. I hope I answered your

5 question.

6 DR. LOSTRITTO: Yes, thank you.

7 DR. WHYTE: Yes, these are your notes.

8 MR. PERGAMENT: -- give you my notes.

9 DR. WHYTE: They're in English, so I can

10 read them. All right. Next we will move -- it's

11 a quartet. Ronald Whitmont, Bernardo Merizalde,

12 David Riley, and Michelle Dossett from the

13 American Institute of Homeopathy. Ronald D.

14 Whitmont

15 DR. WHITMONT: Good afternoon. It is my

16 pleasure to speak to you today and I want to

17 mention that I have no conflicts of interest in my

18 presentation or in my being here today. My name

19 is Ron Whitmont and I'm the current president of

20 the American Institute of Homeopathy.

21 I'm a founding diplomat of the American

22 Board of Integrative Holistic Medicine, a clinical



169

1 assistant professor of family and community

2 medicine, at New York Medical College, and a

3 board-certified internist. I'm also a second

4 generation homeopathic physician.

5 Today I'm speaking to you as president

6 of the American Institute of Homeopathy. Commonly

7 known as the AIH, we were established in 1844.

8 We're the oldest extant national professional

9 medical society in the United States. For the

10 past 171 years, the AIH has been the voice of the

11 professional homeopathic medical community.

12 Our members are licensed physicians -

13 medical, osteopathic, and naturopathic, dentists,

14 nurse practitioners, physician assistants, all of

15 us are trained in homeopathic medicine in addition

16 to the medical and dental training that we

17 maintain for our respective licenses.

18 With regard to homeopathic over the

19 counter products, many of our patients use over

20 the counter homeopathic products as adjuncts to

21 their healthcare. These over the counter medicines

22 fill an important niche for consumers who wish to



170

1 include an extremely safe therapeutic option for

2 their many common and self-limited complaints and

3 to augment their conventional care.

4 These products are exceptionally safe

5 when used in accordance with product guidelines

6 and they do not appear to interact with any

7 conventional medications. In our experience,

8 patients who choose to use homeopathic medicines

9 as part of their treatment regimen, tend to be

10 much more compliant with their medical care,

11 highly motivated, well-educated, and conscientious

12 about their lifestyle choices.

13 As the use of homeopathic medicines

14 becomes increasingly popular, we share the FDA's

15 concerns with regard to the regulation of

16 homeopathic drug products for the protection of

17 public safety. Our concerns about the importance

18 of regulations first became evident in 1938, when

19 three-term Senator Royal S. Copeland, a

20 homeopathic physician from New York and a former

21 president of the AIH sponsored the Food Drug and

22 Cosmetic Act which recognized the Homeopathic



171

1 Pharmacopoeia of the United States.

2 We're here today to continue this work

3 to help safeguard our patients. The AIH believes

4 that the regulatory policies already in place have

5 been very successful in protecting the public from

6 harm; that the vast majority of homeopathic over

7 the counter drug products on the market today are

8 manufactured and labeled in accordance with these

9 guidelines and that only a few manufacturers have

10 marketed products in violation of these guidelines

11 and that the FDA has acted appropriately in

12 removing these products from the market.

13 We believe that the current regulatory

14 structures already in place meet the needs of

15 consumers and provide access to high quality, safe

16 homeopathic products. I'd like to thank the FDA

17 for taking the time to conduct this review of over

18 the counter homeopathic products. We share your

19 concerns about protecting the public from harm and

20 ensuring continued access to these important and

21 clinically relevant medicines.

22 I hope that the AIH can work together



172

1 with the FDA over this issue during my tenure as

2 president. We look forward to integrating our

3 expertise and broad experience with the field of

4 homeopathic medicine with the FDA to help ensure

5 the continued provision of safe and clearly

6 identified homeopathic drugs for the American

7 public.

8 I will now turn this conversation over

9 to my colleagues, beginning with Dr. Bernardo

10 Merizalde, who will speak directly to the question

11 of consumer awareness and the ability to make

12 informed decisions about homeopathy; Dr. David

13 Riley who will discuss how the current regulatory

14 framework is working to enhance safety and

15 availability of homeopathic therapies; and Dr.

16 Michelle Dossett who will present data drawn from

17 current literature on homeopathic safety. Thank

18 you. Bernardo Merizalde

19 DR. MERIZALDE: Thank you, Dr. Whitmont.

20 Thank you for giving us the opportunity to present

21 to you today. My name is Bernado Merizalde and I

22 am a diplomat of the American Board of



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1 Homeotherapeutics and the American Board of

2 Integrative and Holistic Medicine.

3 I'm assistant clinical professor of

4 psychiatry and neurology at Thomas Jefferson

5 University Hospital in Philadelphia. I have been

6 studying homeopathy for about 35 years and I have

7 been in the practice of general medicine and

8 psychiatry and complementary alternative medicine,

9 homeopathy for 25 years.

10 People come to us, homeopaths, by

11 referral from other patients or from colleagues

12 familiar with our work. We are not necessarily

13 any more gifted at treating patients than any

14 other medical colleague. However, our patients

15 believe homeopathy is very effective and an

16 important part of their healthcare. My colleagues

17 and I have been able to treat many patients

18 effectively and less expensively with homeopathy.

19 Our experiences as homeopaths in the

20 U.S. is not unique. It is shared by colleagues

21 around the world. We have similar independent

22 experiences with regard to provider and consumer



174

1 experience and information about homeopathic

2 drugs. The great majority of patients know what

3 they want and are familiar with homeopathic

4 treatment.

5 Many seek homeopathy after years of

6 unsuccessful efforts with conventional medicine

7 from very learned, skilled, and well-intended

8 colleagues. Very often my patients purchase and

9 use OTC products and for urgent non-serious

10 conditions. I may recommend one of them to take,

11 until I can see them in my office at the earliest

12 available appointment.

13 Our patients have enough information

14 from the labeling of homeopathic products to

15 decide when and how to use these medicines in

16 self-limiting conditions. That doesn't mean

17 current labeling could not be improved and

18 educational education can help public and

19 practitioners learn about homeopathy and OTC

20 products more effectively.

21 A number of organizations in companies

22 provide free information about homeopathy through



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1 printed and digital publications, lectures, and

2 websites. These sites are easily accessible

3 through our web search. About one-third of U.S.

4 adults may go online to self-diagnose a medical

5 condition; 46 percent of them decide to get

6 professional medical care based on their findings;

7 while 38 percent believe they can treat their

8 conditions at home.

9 There is no reason to believe this is

10 any different regarding homeopathic medicine. The

11 FDA can help to provide unbiased, factual

12 information about homeopathy. A reference within

13 the FDA website to dependable resources such as

14 the HPCUS and the AIH could help inform consumers,

15 providers, and the media.

16 Hopefully, the National Center for

17 Complementary and Integrative Health of the NIH

18 will also provide more detailed and balanced

19 information about homeopathy; both reliability and

20 quality of this information needs to be assessed.

21 Another way the public gets information about

22 homeopathy is through consumer healthcare support



176

1 groups around the country.

2 Many AIH members are visiting speakers

3 through these groups to teach other MDs,

4 consumers, and patients who want to learn more

5 about homeopathic medicines and their application.

6 Many conventional colleagues show genuine interest

7 and curiosity about homeopathic medicine, despite

8 being challenged by fundamental differences in

9 these medical models.

10 We believe a true scientist does not

11 discard available data only because the theory

12 doesn't correspond to their prevailing world view.

13 Such attitude has, historically, hindered

14 innovation and scientific progress. There are

15 significant possibilities for improvement though.

16 Agencies such as the FDA and the AIH

17 could help to educate the public and providers

18 about homeopathic medicines. Specific attention

19 should be paid to distinguishing homeopathic drugs

20 from dietary supplements, herbal, and nutritional

21 products. The FDA can support funding from

22 reliable research such as encouraging the AIH to



177

1 fund such research which could help better clarify

2 the role of homeopathic medicine in the consumer

3 marketplace.

4 NGOs affiliated to homeopathy like the

5 AHP and the AIH will continue to play an important

6 role in delivering accurate information about

7 homeopathy. Medical schools could better educate

8 future doctors about the different types of OTC

9 drugs including homeopathics, which their future

10 patients will be using.

11 Conclusions. Consumers get educated to

12 make informed decisions about homeopathy just as

13 they do with other OTC products. Patients want

14 the option and the freedom to use homeopathic

15 medicines as a viable resource in their

16 healthcare, to be used not instead of, but in

17 conjunction with standard medical diagnoses and

18 treatment when necessary.

19 Conventional healthcare providers want

20 scientific unbiased information about homeopathic

21 drugs and are willing to examine other medical

22 models, including homeopathic medicine, despite



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1 the fundamental paradigm differences. NGO and

2 government agencies provide basic information

3 about homeopathic medicine, which is often

4 incomplete and at times inaccurate.

5 Collaboration between agencies using

6 available expertise with the most complete and

7 accurate information about homeopathic medicines

8 can solve this problem. AIH members, as licensed

9 providers, represent a potential asset to the FDA

10 with our unique qualification and experience in

11 both conventional and homeopathic medicine.

12 Collaboration with our members could

13 enhance an agency's oversight of the current use

14 of these medicines in the United States. Thank

15 you. Dr. Dossett? Oh, sorry. Dr. Riley. David

16 Riley

17 DR. RILEY: Good afternoon. My name is

18 David Riley. I'm a board certified internist. I

19 live in Portland, Oregon. I've also been a

20 medical editor of four medical journals and

21 currently I'm an editor for the Permanente Journal

22 from Kaiser Permanente and somewhat importantly



179

1 and I'll segue into my presentation here, I've

2 also been responsible for the development of

3 health research reporting guidelines beginning

4 with the CONSORT guidelines in '95 and ending with

5 Case Report Guidelines, the CARE guidelines in

6 2013, which are kind of bookends for how one can

7 begin to assemble evidence.

8 So what about the current regulatory

9 framework that's available today? I think lots of

10 people here today have reiterated something which

11 I'm going to reiterate, that the current

12 regulatory framework is more or less functioning

13 and probably could use tweaking at best.

14 So how are homeopathic drugs regulated

15 today? They're regulated, as people have said

16 before, by the Compliance Policy Guide, which is

17 section 400.400, and the Homeopathic Pharmacopoeia

18 Convention of the United States which publishes

19 the Homeopathic Pharmacopoeia of the U.S., and

20 then of course all homeopathic pharmaceutical

21 companies are registered under 21 CFR.

22 Most of the homeopathic drugs that are



180

1 used in commerce today or virtually all of them

2 are listing in the Homeopathic Pharmacopoeia of

3 the United States, an addendum to it, or its

4 supplements and this has been the law since 1938.

5 The potencies of homeopathic drugs are

6 specified on the label and they also contain

7 diluents that are commonly used in the homeopathic

8 pharmaceutical industry. Drug products containing

9 homeopathic ingredients in combination with non-

10 homeopathic active ingredients are clearly

11 outlined in the CPG as not homeopathic drug

12 products.

13 So I think that in terms of that

14 confusion, there are some products that are both

15 herbal products and are also official homeopathic

16 products but they should be labeled clearly as

17 such. So they're homeopathic drug products can be

18 categorized as prescription only and those may

19 only be dispensed pursuant to a prescription order

20 by a person qualified to prescribe according to

21 their scope of practice in the state in which

22 they're licensed.



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1 So as a member of the American Institute

2 of Homeopathy, all of its members are aware of the

3 benefits and limitations of both homeopathic

4 medicine and conventional medicine. Most of the

5 people, all of the members of this organization

6 have conventional training as well as homeopathic

7 training. And many people in this group also have

8 expertise in other areas of medicine too,

9 including regulatory and research, and Michelle

10 will be the one to talk about some of the research

11 activities.

12 So a guide to the use of homeopathic

13 drugs may be found by referring to the Materia

14 Medica Text. John Henry Clarke is the most

15 substantial one, but there is about 30 or texts

16 that are used today. These are some of the

17 labeling regulations that are in existence here,

18 which have already been talked about by other

19 people.

20 These are some of the labeling

21 guidelines that are in place for both prescription

22 and over the counter medications and I think



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1 they're largely working for practitioners,

2 patients, and since all of us are consumers,

3 whether we're practitioners or patients, I think

4 it's working for us too.

5 I think it's generally recognized that

6 homeopathic medicines are safe. As I review the

7 various documents from things like the Poison

8 Control, I don't see many adverse events or toxic

9 events that can be linked to homeopathy.

10 What are the 10-year review (ph) of the

11 warning letters? There's 48 warning letters that

12 have been just given out for homeopathic products.

13 They include HCG, which is biologic. There's

14 seven letters there. Unauthorized H1N1 flu

15 products. There's six letters there. And there's

16 misbranding -- the misbranding has tended to fall

17 into two categories: Rx only products marketed for

18 OTC use, and what's Rx and what's not is a grey

19 area as other people have discussed; and then

20 combining homeopathic and non-homeopathic or

21 allopathic active ingredients, and of course a

22 question was raised earlier about some of this;



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1 and then violations of GMP for which there were 10

2 letters.

3 I think that the current regulatory

4 process is by and large adequate. It's defined by

5 the HPCUS and the HPUS and the CPG. Informed

6 consumers use homeopathic drugs and for the most

7 part, in my experience, they understand what

8 they're doing. I'll now turn it over to Michelle

9 to review some of the research literature.

10 Michelle Dossett

11 DR. DOSSETT: Thank you, David. Good

12 afternoon and thank you for the opportunity to

13 speak today. My name's Michelle Dossett. I am an

14 internist and clinical researcher at Massachusetts

15 General Hospital in Boston and instructor at

16 Harvard Medical School. I have a Ph.D. in

17 Immunology and a Master's in Public Health and

18 Clinical Effectiveness.

19 I became curious about homeopathy on

20 seeing some of its clinical effects and reviewing

21 the research literature. I'll be speaking today

22 on behalf of the AIH on the safety of homeopathic



184

1 medicines and on public perceptions. My only

2 financial disclosure is two hours of consulting

3 that I did for the homeopathic pharmaceutical

4 company last year.

5 First, I'll address the FDA's question

6 regarding safety or risks of products labeled as

7 homeopathic. I will not be discussing efficacy

8 today due to time limitations. Dr. Jonas did an

9 excellent job yesterday of discussing some of the

10 challenges in interpreting research in this field,

11 and the importance of critically analyzing the

12 methodology used.

13 Physicians within the AIH report that

14 while adverse events do occur with homeopathic

15 treatment, such occurrences are magnitudes less in

16 frequency than their experiences with conventional

17 medicines, and these events tend to be mild and

18 transient in nature. Many relate that the safety

19 of homeopathic medicines is helpful in prescribing

20 for complex patients, such as older patients who

21 are on multiple conventional medications for

22 chronic medical conditions.



185

1 We know that as the number of

2 medications increases, the risks for interactions

3 and adverse drug interactions increases as well.

4 Our members find that homeopathic medicines

5 represent a much safer alternative for self-

6 limited conditions in these patients. Rather than

7 using an OTC drug like an NSAID which might be

8 contraindicated, short-term use of a homeopathic

9 medicine can help alleviate symptoms while

10 reducing concerns for adverse drug reactions.

11 And while such anecdotal information is

12 helpful, let's now review some of the research on

13 the safety of homeopathic medicines. In 2000,

14 Dantes and Rampes published a systematic review of

15 the literature from 1970 to 1995. They found 19

16 clinical trials with detailed information on

17 adverse events and found a mean incidence of

18 adverse events of 9.4 in the homeopathic groups

19 and 6.17 in the placebo groups. The adverse events

20 were mild and transient.

21 They also looked at case reports and

22 found that the majority of those described



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1 aggravations of pre-existing symptoms, rather than

2 new symptoms, and that the overall level of causal

3 association was low. Some reports describe

4 products that were mislabelled as homeopathic.

5 For homeopathic pathogenetic trials they examined,

6 there was great heterogeneity. The mean incidence

7 of effects was 54 percent and overall they were

8 similar to nocebo effects found in Phase I RCTs.

9 The Health Technology Assessment

10 Commission by the Swiss government examined the

11 safety of homeopathy and concluded that the use of

12 medium and high potencies is free from toxic and

13 unexpected organ effects. I'll now review some of

14 the data that's been published since.

15 In 2012, Jong and colleagues examined

16 pharmacovigilance data from Germany on the use of

17 homeopathic and anthroposophic solutions sold for

18 injection; the practice of injecting homeopathic

19 medicines is far, far more common in Germany than

20 in the U.S.

21 Of 303 million ampules sold for

22 injection, there were only 486 case reports,



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1 encompassing a total of 1,180 adverse drug

2 reactions. Only 46 of the reports were classified

3 as serious, and in nearly half of those cases, the

4 homeopathic injection was deemed unlikely to be

5 the cause of the event.

6 Serious adverse drug reactions occurred

7 significantly more frequently in those who

8 received complex products and products diluted

9 less than one in ten thousand. The overall

10 reporting rate of adverse drug reactions was less

11 than four per one million ampules sold.

12 Let's examine another report now, a

13 highly publicized paper by Posadzki and

14 colleagues. The senior author on this paper,

15 Professor Ernst, is a well-known critic of

16 homeopathy. In this systematic review of the

17 literature from 1978 to 2010, the authors found a

18 total of 1,159 case reports of adverse events from

19 homeopathy published from 17 different countries.

20 The adverse events ranged from mild to

21 severe and included four fatalities. The most

22 common adverse events were allergic reactions and



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1 intoxications. Upon examining the paper in

2 further detail, one finds that 1,070 of these

3 reports are of "unspecified remedies" reported to

4 a German poison control center, much like the

5 reports from our own national poison data system.

6 There is no validation that all of these

7 1,070 reports are of actual homeopathic products

8 and the vast majority of these cases represent

9 accidental ingestions by young children with

10 limited or no side effects. Again, very similar

11 to the situation here in the United States.

12 On reviewing the remaining 89 cases many

13 are again of unspecified compounds. In other

14 words, we don't really know if they're homeopathic

15 medicines, and if they are, whether they're single

16 or complex products or have other non-homeopathic

17 ingredients added to them. Some of the compounds

18 ingested are reported by name and are clearly not

19 traditional homeopathic medicines and may contain

20 non-homeopathic ingredients.

21 Nearly all of reports lack documentation

22 of concomitant conventional medical treatment.



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1 Several did use traditional homeopathic medicines,

2 but in very low dilutions. Mother tinctures of 1X

3 potencies that is 10-to-the-minus-one dilution,

4 which would generally not be prescribed by

5 homeopathic providers in this country.

6 Finally, several of the adverse events

7 are clearly misattributed. For example, the

8 authors attributed a case of bladder cancer that

9 developed seven years following homeopathic

10 treatment to the homeopathic medicine that was

11 given. In summary, it's rather remarkable that a

12 review of 32 years' worth of literature across 17

13 countries, many in which homeopathy is used quite

14 widely by the general population, found little

15 evidence for serious toxicity from homeopathic

16 treatment.

17 In the interest of time, I'm going to

18 skip through the next several slides on data from

19 the national poison data system. That was well-

20 explained by Dr. Krenzelok yesterday. I'll only

21 reiterate two points and that is that it's unclear

22 what proportion of these exposures were truly



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1 homeopathic medicines, versus other products

2 claiming to be homeopathic on the label, but also

3 containing pharmaceutically active amounts of

4 herbs, dietary supplements, or pharmaceuticals.

5 And second, that the homeopathic products appear

6 to have a better safety profile than other

7 pharmaceuticals in the database examined.

8 I now want to briefly share some

9 information on perceptions of homeopathy users in

10 the United States. According to the most recently

11 published data from the National Center for Health

12 Statistics and the NIH published in February of

13 this year, as of 2012, over five million American

14 adults, or 2.2 percent of the U.S. population had

15 used homeopathy within the past year. This number

16 represents an increase from 1.8 percent in 2007.

17 In collaboration with my colleagues at

18 Harvard Medical School, I've analyzed data from

19 the 2012 National Health Interview Survey on the

20 use of homeopathic medicines among U.S. adults.

21 This data has not yet been published which is why

22 I don't have the figures to show for you today,



191

1 but I'll walk you through the data that we found.

2 Homeopathy was most commonly used for

3 respiratory and ear, nose, and throat complaints,

4 things like head and chest colds, sore throats,

5 allergic rhinitis. This represented 19 percent of

6 American adult use of homeopathy.

7 Another 12 percent used homeopathic

8 medicines for musculoskeletal complaints such as

9 sprains, muscle, and joint pain. We found that 81

10 percent of users did not see a practitioner and

11 presumably self-prescribed or prescribed based on

12 the recommendations of friends or family.

13 The survey also asks about, for each of

14 the complementary or integrative modalities that

15 are surveyed, how much this helped your health-

16 related condition. And among those who used

17 homeopathy or dietary supplements as one of their

18 top three complementary therapies to address a

19 health-related condition, 32 percent of those who

20 used dietary supplements felt that it helped their

21 health-related condition a great deal.

22 In contrast, 42 percent of those using



192

1 homeopathy who did not see a practitioner and 64

2 percent of those using homeopathy who did see a

3 practitioner found that it helped their health-

4 related condition a great deal.

5 In summary, in reviewing the research

6 data, homeopathic medicines are safe, especially

7 compared to other OTC products. While adverse

8 events are reported with homeopathic medicines,

9 the vast majority are mild and transient. Use of

10 homeopathic medicines in the United States is

11 increasing and users frequently find them to be

12 helpful. Thank you very much for your time and

13 attention.

14 DR. WHYTE: Thank you. Thank you all

15 for your presentations. Before we start the

16 questions I do have a request for everyone. If

17 everyone could just reach for your phone, if you

18 could reach for your phone and the reason why I

19 ask is because someone out there doesn't have

20 their phone, because I have their phone.

21 So somebody's missing a phone, and if

22 you can tell me what's the screensaver, I'll give



193

1 it back to you. And I'll stand in the back while

2 I allow the questions to start and we'll start

3 with Charles on the very end and we'll come

4 forward. And I didn't see who had their hand up,

5 because I looked as well away, but I'll be in the

6 back with your purple phone.

7 DR. WU: There's a mention a couple of

8 times about the homeopathy, the medicine in the

9 low potency and the high potency. So I just

10 wonder what kind of analytical method you use to

11 assess high potency and low potency. And related

12 to that question, and also clinically do you have

13 any clinical data to establish the relationship

14 with high potency and low potency?

15 DR. RILEY: I'll just say one thing,

16 it's an area of controversy within homeopathy and

17 it varies culturally. Generally, the X potencies

18 which are decimal dilutions tend to be lower, 6,

19 12, 30s. The C potencies which are centesimal

20 dilutions tend to be higher, and it's culturally

21 driven to some extent. There is clinical data, but

22 there's not systematic clinical data comparing



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1 potency used for certain conditions.

2 DR. MERIZALDE: From as manufacturing

3 standpoint, I have to qualify that I am not a

4 manufacturer and I'm not certainly a pharmacist,

5 but from my understanding, it is easier to test

6 the lower potencies, and what we're looking at is

7 the reliability of the original substances from

8 which the medicines are used.

9 So we're really following the guidelines

10 of HPCUS and looking for those quality standards.

11 So once we start reaching that Avogardo's number,

12 which will be like a 12C potency, from then on we

13 are relying on the original substances, and that

14 the procedures, the processes of the production of

15 those higher potencies is going to be equally high

16 quality.

17 DR. WU: Thank you.

18 DR. NELSON: Sorry, I was thinking about

19 my question. A question for Dr. Riley and Dr.

20 Dossett and I'm interested in drawing you out a

21 bit on thoughts you might have towards

22 establishing the effectiveness of these products



195

1 and while you're thinking about that, let me just

2 make a couple of comments.

3 I mean the FDA thinks about feel,

4 function, and survive; that's what we think about.

5 Now, we seem to be in domain here of feeling and

6 not functioning and surviving, which is fine. And

7 in that context, even allopathic products

8 sometimes have difficulty showing changes in

9 feeling and you get into such issues as patient-

10 reported outcome measures or observer-reported

11 outcome measures and there's even discussion as to

12 whether or not, given the variability in response,

13 that we heard I think in a comment earlier today

14 or perhaps yesterday, that you may have five

15 people with one disease, all of whom have five

16 different symptoms.

17 There's that discussion going on in the

18 allopathic world about whether or not you need

19 patient specific measures. And so you know given

20 your comment about CONSORT and the like, which I'm

21 very familiar with, is there any thought about

22 trying to establish standards for what would be



196

1 considered not provings, but FDA would have the

2 proving, efficacy trials for these products?

3 DR. RILEY: I'll just say one thing and

4 then turn it over to her. I certainly think

5 PROMIS, using things like the PROMIS instruments,

6 plus protocol- driven N of one guidelines are a

7 way to begin to get at individual effects and this

8 is taking place in conventional medicine. There's

9 now case report guidelines out there for

10 systematically collecting and reporting data which

11 can begin to create evidence out of patient

12 collected outcomes.

13 DR. DOSSETT: I would echo that and add

14 looking at longitudinal analysis of how patients

15 do over time and comparative effectiveness

16 studies. And I think once of the major challenges

17 right now to doing research in this field is the

18 lack of funding. It's not a funding priority and

19 for investigators who want to do research in this

20 field, it's very challenging for that reason.

21 DR. NELSON: And just a quick follow-up.

22 I agree the funding is a problem, but among the



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1 homeopathic practitioners and those who are

2 sympathetic to homeopathy, one could try to

3 develop some standards around how to conduct these

4 kinds of clinical trials. I mean that could be

5 done with --

6 DR. RILEY: Actually, that's being done

7 right now.

8 DR. NELSON: Okay.

9 DR. RILEY: People are beginning to

10 develop -- for example, the CARE guidelines for

11 case reports were written as an architecture for

12 how to collect case reports. So each specialty

13 needs to develop their own specific guidelines and

14 homeopathy is in the process of doing that right

15 now. There's -- some publications have come out

16 and some more are in press right now.

17 DR. WHYTE: Richard?

18 DR. LOSTRITTO: Yes, briefly. My

19 question is to Dr. Dossett. In terms of the

20 adverse reactions with injections, were any of

21 those attributable to sterility problems? And as

22 an add on to that, are any homeopathic products



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1 that are injections, multiple dose? And if so, do

2 you know if they're preserved?

3 DR. DOSSETT: Great questions. I'm not

4 that familiar with homeopathic medicines for

5 injection, because in this country it's almost all

6 oral, some topical. So I don't know what's going

7 on with the injections in this country. In the

8 German pharmacovigilance study about a quarter of

9 the reactions were simply injection site

10 reactions.

11 I haven't had a chance -- in that actual

12 paper that I cited, they didn't say anything about

13 sterility issues or systemic infections from the

14 injections, but I haven't actually seen the

15 original data myself.

16 MS. LIPPMANN: I have a question about

17 the role of federal agencies including FDA. You

18 have a slide that encourages research funding to

19 help document the safety profile of homeopathic

20 medicines and help ensure availability of current

21 research on homeopathic products, and that's under

22 the heading of -- role of agencies including FDA.



199

1 It seems as though you're advocating

2 more FDA involvement then in demonstrating or

3 establishing safety and efficacy, and I'm

4 wondering how does this reconcile with the current

5 system under the CPG, in which FDA essentially

6 stays out of the question of particularly efficacy

7 of homeopathic products.

8 DR. MERIZALDE: I don't think that we're

9 necessarily asking the FDA to fund the research.

10 If you can that'll be wonderful. We would love to

11 validate efficacy. And one of the problems that

12 happens in the current research is that many

13 people that are not even familiar with homeopathy

14 decide to start doing a trial on a particular

15 disease, choosing one particular substance and

16 then at the end say, Oh, homeopathy doesn't work.

17 Well, they didn't follow the protocol,

18 which is individualizing the medicine. As has

19 been said before, a particular disease may come up

20 with five different medicines for different

21 people, depending on their unique symptomatology.

22 So it's going to take a lot of resources



200

1 to be able to do such work. It can be done, but

2 we need the funding. So if the FDA can encourage

3 NIH to have a fair and balanced grant setting that

4 has experts in homeopathy be part of those

5 protocols, that would be wonderful.

6 MS. LIPPMANN: Thanks.

7 DR. IZEM: Hello. I have a question for

8 Dr. Dossett. I think, I hope it's just a simple

9 question. So from the literature that you

10 presented, did they separate at all between OTC

11 and prescription or one single ingredient versus

12 multiple ingredients? And then a follow-up

13 question is, are those databases available in the

14 U.S.? Could we conduct such a study in the U.S.?

15 DR. DOSSETT: OTC versus pharmacologic,

16 I don't recall. The German database was just

17 ampules sold, so I'm assuming it could include

18 both. I'm not as familiar with the German

19 regulatory framework in terms of how they define

20 OTC versus prescription. I do not know what the -

21 - I'm assuming that the manufacturers here in the

22 United States do have databases where they keep



201

1 track of reports that they get back, but I would

2 take that back to my colleagues at the American

3 Association of Homeopathic Pharmacists for their

4 feedback on that.

5 DR. MERIZALDE: In addition to that, one

6 of the things, for example, is a company has a

7 cough syrup. They are two different kinds, and

8 one of them may have one particular set of

9 combination remedies and the other one has a

10 different set. If you prescribe to a particular

11 patient that needs product A or that has an

12 ingredient there that would respond to product A,

13 what was talked about earlier, about the

14 hyperergic condition of the patient, they will

15 respond to product A.

16 If you give product B, they will not

17 respond. So in a trial like that, it would need

18 to be seen that these patients that are receiving

19 product A or product B, actually would correspond

20 to one of the components that are in those

21 particular OTC products, which is why doing an OTC

22 combination remedy trial is going to be even more



202

1 complex than a single remedy approach.

2 DR. WHYTE: Thank you. Okay. At this

3 time, I'd like to introduce David Chipkin from

4 Parmesh Banerji Life Sciences, LLC. David Chipkin

5 MR. CHIPKIN: Good afternoon, everybody.

6 Break is after me, so I'll try and go fast. I

7 would like to thank the panel members for allowing

8 us to speak today. My name is David Chipkin. I'm

9 the vice president of U.S. projects representing

10 the Parmesh Banerji Life Science Group.

11 I'm not a medical doctor, I'm not a

12 pharmacist, I am not a scientist, but I am working

13 with Dr. Banerji with my expertise in business

14 management and in operations. I have been working

15 in pharmaceutical manufacturing and Dr. Banerji

16 had a vision with his team to come to the U.S. and

17 set up a proper manufacturing facility under the

18 FDA guidelines and that's what I'm doing, and I'm

19 enjoying it, because we're bringing jobs back to

20 the country, which is awesome.

21 I'd like to state, for the record, that

22 we have no financial relationships with any other



203

1 company or group that may be affected by the

2 outcomes of these meetings.

3 We at Parmesh Banerji Life Sciences

4 Group bring a unique and most and deep

5 understanding of the aspects of homeopathy. This

6 is based on our 97 years of interrupted

7 experience, having the world's largest body of

8 evidence and global perspective of homeopathy.

9 I'd like to start by giving a short

10 background of our organization and we will address

11 the questions as well, but it's important to know

12 that we will be submitting an in-depth paper by

13 the June 22nd deadline, which will have a lot of

14 information, that I know you'd like to see and I

15 know that Dr. Banerji knows you'd like to see it

16 and we feel strongly that we have a lot to offer

17 in the paper.

18 So the 97 years of uninterrupted

19 experience in homeopathic healthcare service

20 delivery, medicine manufacturing, clinical

21 research, and practitioner training. Dr. Parmesh

22 Banerji's grandfather started the first clinic in



204

1 1918 for the sole purpose of supplying free

2 medicines and healthcare services for all those

3 that could not afford them.

4 The practice was maintained until 1974,

5 56 years since opening. Dr. Parmesh Banerji

6 himself has been involved with all four of these

7 phases for the past 22 years. And we believe we

8 have a wealth of knowledge and learning which is

9 almost a hundred years. Having the world's

10 largest body of evidence from the most well-

11 documented cases, with medical records like blood

12 works, scans, we have millions of prescriptions

13 that have been served, and having the widest range

14 of diseases treated using homeopathy.

15 See I say it both ways, because I have

16 to go by what the U.K. says and what the U.S.

17 says. Our global presence in homeopathy from our

18 point of presence in India, the U.K., and the USA;

19 our patients come from 87 countries, all manner of

20 backgrounds from deep rural communities in third

21 world countries to European and North American

22 metropolises.



205

1 We are speaking here today to register

2 the point that we are going to present a very

3 detailed written submission covering our views on

4 every aspect of the homeopathic regulatory

5 framework within the 22nd of June, 2015 deadline.

6 Again, European way to say a date. Our written

7 detailed submission by June 22nd will cover all

8 the aspects mentioned in the FDA's notice, a

9 summary of which is given in this presentation.

10 So question number one which deals with

11 consumer and healthcare provider attitudes. From

12 the consumer perspective, they are the safest

13 medicinal substances known to man. In case they

14 don't help, they will never harm. From the

15 healthcare service provider, many conventional

16 medicine practitioners either refer some of their

17 patients to homeopaths or they themselves

18 prescribe homeopathic medicines to help patients

19 where conventional medicines fail to deliver, or

20 as I've learned and heard over the last couple of

21 days, they use them to complement the medications

22 that they have at their disposal.



206

1 The percentage varies widely between

2 countries who do this and we have a lot of data on

3 that as well. There are other conventional

4 medicine practitioners that think that homeopathic

5 medicines don't have any medicinal property and

6 therefore, by extensions, confirm that they cannot

7 harm the patient, even if they cannot help.

8 Question two on data sources. One of

9 the only data sources that can be of meaningful

10 benefit to the FDA are from homeopathic healthcare

11 service providers, wherever they are in the world,

12 that have statistically significant number of

13 prescriptions served, at least 10,000 plus a year.

14 Now again, I've heard over the course of the last

15 couple of days that there are a lot of

16 organizations within the industry that also have

17 information that could be used.

18 We will be very willing to support the

19 FDA significantly in this matter, with the

20 assumption that appropriate resources for

21 evaluation of the information evidence data are

22 made available. We agree and believe that it has



207

1 to be statistically significant. And again, we

2 have a lot of information to offer.

3 Question three and four on enforcement

4 under the CPG. In summary, the enforcement

5 policies we feel are adequate and in principle, we

6 are one with the AAHP in this matter and also some

7 other presenters that were up yesterday and today.

8 I feel that we all stand united on this.

9 The only area of improvement can come

10 from FDA's better understanding of the

11 circumstances under which homeopathic products are

12 used, prescribed, and resorted by patients. This

13 public hearing is a great starting point in

14 learning for everybody. And again, other

15 presenters have recommended the possibility of

16 having a subject matter expert be part of the FDA

17 discussion and we encourage that as well.

18 Also, a better understanding of what the

19 term homeopathic products represent in the current

20 context in terms of the substance, process of

21 manufacturing, and also the categories that they

22 may be classified for better regulation.



208

1 Again, we're going to be submitting a

2 detailed documentation that will be part of the

3 June 22nd submission. Question five, information

4 regarding regulations in other countries -- we do

5 not feel the FDA should look at regulatory

6 guidelines from other countries, except now I'm

7 rethinking that; Canada can be included, because

8 Canada was here yesterday and I heard a lot of

9 good stuff. Is she here today? Yeah, are you

10 here? Then you're still included.

11 No seriously, we know that when the FDA

12 speaks, other countries listen, except for Canada.

13 They probably do their own thing. The FDA should

14 use this public consultation as a platform to

15 create the new perspective for regulatory

16 framework of homeopathy in the USA, which other

17 countries can look up to, and again, we'll be

18 submitting information on this.

19 Question six on indications. We really

20 don't have enough time to respond on this, because

21 this is a big subject as we've heard from

22 everybody. We will respond appropriately in the



209

1 paper that we will be doing. We'll give some key

2 pointers though.

3 The current practices related to

4 labeling borrow the shortcomings from the

5 anomalies surrounding the policies about who can

6 prescribe. So there is some confusion on Rx

7 versus OTC, and that's something that -- can just

8 a medical doctor do it, or can someone that has a

9 license, but not from a Board, but they do know

10 homeopathic remedies. I'm running out of time.

11 The overarching conclusion about the

12 validity of homeopathic products being put in the

13 category of OTC is supported by the scientific

14 fact that being diluted naturally substances, they

15 are safe and can pose no threat. I'll skip

16 through number seven, because I think we all are

17 on the same page with labeling.

18 And again, we're going to submit a

19 detailed report, we call it 360, because we were

20 involved in every aspect of it, from having our

21 own clinics, having patients come in, get

22 diagnosed. We have the manufacturing capabilities



210

1 and we have diagnostics after that, and we've done

2 a lot of clinical research, which again we're

3 willing to share. Thank you for your time.

4 Please be kind to me. I'm not a scientist and I

5 probably won't understand what you're saying, so

6 I'm just going to say right now, I'm going to

7 refer to Dr. Banerji.

8 And by the way, seriously, Dr. Banerji

9 really did want to be here today. He was in

10 transit from the U.K. back to India, and it was

11 just physically impossible to do, but he did want

12 to offer that he will adjust his schedule if you

13 would like him to come to the FDA complex, he'd be

14 more than happy to spend a day to go over

15 everything that you might have questions for. So

16 I just want to throw that out there to you. Okay,

17 no questions, because the other two --

18 DR. WHYTE: Wait now, there are some 10

19 cards up. That was -- you'll be fine. All right.

20 Okay. Well maybe we better start with Judith

21 then. Let's -- and then we'll move to Dr. Nelson.

22 DR. MCMEEKIN: What would be an adequate



211

1 measure of quality for homeopathic products in

2 your opinion?

3 MR. CHIPKIN: Well, it's really not my

4 opinion. It's following the guidelines that are

5 set out for homeopathic manufacturers by using the

6 HPUS and by using the USP and also following the

7 guidelines that are set out by the FDA.

8 DR. NELSON: You had mentioned that you

9 had data that you would hope could be brought to

10 bear on some of these questions, provided there

11 were adequate resources.

12 MR. CHIPKIN: Yes.

13 DR. NELSON: Now I'm not suggesting we

14 have them and you may not have them, but I'm

15 interested in just asking, could you describe the

16 nature of the data that you would have?

17 MR. CHIPKIN: Yes, I can. There's 97

18 years' worth of data that's been collected.

19 Mostly all of it from the 1930s on, have been --

20 and this is the clinical data from people coming

21 in -- have been archived. Now with the

22 technologies, everything has been scanned in



212

1 before and afters. There's literally tens of

2 thousands, and breaking down into the different

3 categories, which I think is something which

4 questions have been coming up over the last couple

5 of days. So there is a lot of data, and yes, we

6 do say there's a resource issue of going through

7 everything, and obviously that would have to be

8 looked at, but we're very willing to share it.

9 DR. WHYTE: Wasn't so bad.

10 MR. CHIPKIN: No, it was great.

11 DR. WHYTE: Well, now we will start our

12 break. We're just a couple minutes behind

13 schedule. So we will resume at 2:30 promptly.

14 Thank you.

15 (A recess was taken.)

16 DR. WHYTE: All right. We're going to

17 go ahead and get started. I know there are some

18 members of the media who have questions, and as

19 you know our policy at the agency is to refer you

20 to our press officer. We have Lindsay Meyer here

21 today. Yesterday, we had someone different. So if

22 you were looking for Chris Kelly, he's not here



213

1 today, but we are in Lindsay Meyer's very capable

2 hands.

3 So for members of the press, if you have

4 any questions and I know some of you have been

5 trying to approach the panel members directly, but

6 our general policy is that you direct your

7 questions to the press officer, Lindsay, and she

8 will get your question to the right person at the

9 agency. So that's our desire to get you the right

10 person to ask; not to prevent you from asking

11 questions.

12 All right. With that we are in the home

13 stretch and we now hear from Yale Martin. Yale

14 Martin

15 MR. MARTIN: All right. Thank you.

16 Appreciate the opportunity to this afternoon to

17 speak to the crowd and to the panel as well. My

18 intent is really to provide some perspective from

19 a retailer standpoint, as well as from a consumer

20 standpoint.

21 I spent the last 25 years of my career

22 in retail. Eighteen of those years, were at



214

1 Walmart stores; they're the largest retailer in

2 the world. I was a buyer there for a number of

3 years. In my last position, I ran the over the

4 counter merchandising area, responsible for about

5 4,000 items that sat in front of the pharmacy for

6 Walmart's nearly 5,000 stores.

7 That included homeopathic products as

8 well as all OTC and just basically anything that's

9 non-prescription. While I'm basing my comments

10 from this experience, I understand -- I did retire

11 in November, so all the comments that I have are

12 mine personally and don't reflect any retailer in

13 particular.

14 First thing I want to mention is,

15 consumers today are far more educated about

16 medications than when I began working in OTC about

17 10 years ago. They're using the Internet, they're

18 using other resources to educate themselves in an

19 effort to better care for themselves and treat

20 their minor conditions.

21 Consumers are short on time and money

22 and for minor inconveniences and less serious



215

1 ailments today's consumers often do not first go

2 to a physician, so continued access to a wide

3 variety of affordable healthcare solutions is

4 critical to their well-being.

5 This is even more important, because

6 about 10,000 Americans turn 65 each and every day.

7 This ageing population will continue to have

8 health issues and their health issues typically

9 increase. The need for access to efficacious

10 self-treatment options will only continue to

11 increase as that population ages into their golden

12 years.

13 The homeopathic products sold today in

14 typical mass retailers are successfully used by

15 tens of thousands of consumers every day. The

16 free market system has a tendency to quickly

17 eliminate items which do not meet consumer

18 expectations, since they are not repurchased.

19 Items that fail to meet a retailer's

20 minimum threshold for movement are quickly

21 replaced by other items. Shelf space is the most

22 valuable commodity that any retailer has, and



216

1 items that disappoint consumers or do not meet

2 their expectations do not last long in any

3 retailer.

4 Many, if not most, of the manufacturers

5 of homeopathic products are conservative long-

6 established companies. Some of these companies

7 are nearing a hundred years old. These companies

8 have a history of producing quality products that

9 address health issues of importance to consumers.

10 Any additional restrictions, restrictive

11 regulations on the homeopathic drug products would

12 hinder the public's access to these products and

13 would significantly limit consumer choices.

14 In my previous position, I had

15 relationships with almost 300 different

16 manufacturers. The homeopathic product

17 manufacturers were never a particular concern from

18 the standpoint of their ethics and just the way

19 they conducted themselves in business.

20 I'm not an expert on homeopathic

21 regulations that are the heart of this meeting.

22 You probably know that; I'm just an old buying



217

1 retailer. But I do know that products that fail

2 to meet consumer expectations in term of the

3 quality, efficacy, and safety do not last long in

4 a retail environment.

5 And when they don't grow in sales

6 volume, they're delisted by the buyer. The buyers

7 are held accountable for their numbers and if the

8 products don't sell because consumers don't find

9 them efficacious, they are eliminated quickly.

10 And that's all I really have to say. I certainly

11 welcome any questions from the panel.

12 DR. WHYTE: Thank you, Mr. Martin for

13 that perspective and we'll start with Dr. Nelson.

14 DR. NELSON: So I realize you're here on

15 your own and not as a representative of Walmart,

16 but I'm just wondering based on your experience,

17 we've had a lot of questions on our part about how

18 people make choices when they approach a shelf

19 that has a mix of OTC products, both allopathic

20 and homeopathic, and I'm wondering based on your

21 understanding of consumer behavior, whether you

22 could provide some insight from your perspective



218

1 about the nature of those choices, how much it's

2 based on price sensitivity, packaging, location,

3 and so on so forth. I mean just a sort of broad

4 sense of your perception of consumer behavior. As

5 I understand on it, based on -- when you scan our

6 credit cards you probably know my consumer

7 behavior, but you probably can't look that up at

8 the moment, so -- interested in what you have.

9 MR. MARTIN: Certainly, and I've have to

10 paint this with kind of a broad brush too, because

11 not every consumer is the same. You mentioned

12 price sensitivity, there are consumers that shop

13 based on that shelf strip and they're looking for

14 the lowest priced on the shelf. People do shop

15 that way just because they're looking for the

16 lowest priced item. Not every customer, but some.

17 I think, first of all, I think consumers

18 are fairly well-educated. They're going to the

19 shelf. They're trying to find something to relieve

20 some kind of a symptom. They're reading the

21 packages. I think when it comes to understanding

22 homeopathic products versus just regular OTC



219

1 products, I'm not sure any of them do. To be

2 honest with you, I couldn't tell you how a inter-

3 nasal steroid works versus a tableted allergy

4 product like a Claritin or an Allegra. So I don't

5 really know how they work. But if I buy it and it

6 works, I come and I repurchase it because it took

7 care of a need that I had.

8 I think the consumer today is reading

9 labels. They're identifying different products

10 and I think certainly the homeopathic products

11 that were carried and that I supervised, were all

12 carried the FDA, you know, this product not

13 evaluated by the FDA. You know the saying. So I

14 think that goes a long way towards identifying

15 homeopathic products versus other products.

16 I mean at the end of the day, I think

17 they're reading labels, they're comparing prices.

18 They're looking at generics. If it's related to a

19 regular OTC drug, they're looking at generics as

20 an option to a brand name. They're looking at

21 homeopathic products. They're researching

22 products on the Internet. I think more and more



220

1 they're also looking at reviews of those products.

2 So products that get great reviews from

3 consumers that had a good experience will continue

4 to sell well, and those that don't will end up

5 being delisted at some point. I think to the

6 point of what happens to items that don't work,

7 every item that goes -- every time you buy

8 something in a store and whether it's a Walmart

9 store or any other store, every time it scans over

10 the register that's kind of a vote for that item.

11 It's a vote for that item to stay in.

12 And if it doesn't get enough swipes over

13 the register, then typically after about six

14 months it's gone, because that shelf space is

15 super valuable and it's not paying its rent. So

16 hopefully I answered your question.

17 DR. LOSTRITTO: Thank you. I'd like to

18 follow-up on that. You had in a position to see a

19 lot of the over the counter products in your

20 career, and I'd like to know if you observe or

21 have any opinion as to whether homeopathic

22 products have any more or any less quality issues?



221

1 And by quality issues I know they have to be

2 loosely defined here for the sake of the consumer,

3 such as defects in packaging, discoloration, or

4 appearance problems, off color, or taste, things

5 like that, if you've had any experience with that

6 in homeopathic products.

7 MR. MARTIN: You know, my personal

8 experience -- and again, I had exposure to just

9 under 4,000 items so it's hard to think back.

10 It's such a wide base of products. But overall --

11 and I would get consumer complaints; on occasion

12 consumer complaints would find their way to me,

13 usually by way of the president and then the

14 senior vice president, you know how that goes.

15 But my perception is that overall the

16 homeopathic products and the suppliers that are

17 engaged in that business have far less, far less

18 issues than did the majority of other items that

19 were on the shelf. And you know, most of them

20 have been in business for years and years. So

21 very conservative companies, never really on the

22 list of problem children that I had.



222

1 MS. LIPPMANN: You said that you think

2 consumers are reading labels, doing their

3 homework, doing their research about products. Do

4 you think that holds true in cases where the

5 homeopathic products on the shelves are in

6 packaging that's made to be very similar to

7 allopathic counterparts?

8 MR. MARTIN: I think a lot of that

9 research gets done, gets done at home before they

10 ever get to the store, particularly for that

11 consumer that's looking for something very

12 specific. You know it's hard to say. Whether

13 packaging that mimics an OTC drug is any more or

14 less viewed by a consumer in any particular

15 framework. I don't know. I really don't.

16 MS. LIPPMANN: Thanks.

17 DR. NELSON: Just a follow-up for my

18 particular interest. A number of years ago there

19 was a fair amount of discussion of the use of

20 the counter allopathic cough and cold products for

21 children less than four years of age, which I was

22 involved in from an FDA perspective. I'm just



223

1 wondering, did you see any shifting within that

2 age group to homeopathic products? Could you

3 tell, could see that shift? I'm just curious. It

4 would probably been about three or four years ago,

5 maybe even continuing.

6 MR. MARTIN: A shift from OTC to

7 homeopathic?

8 DR. NELSON: Well, from OTC allopathic,

9 you know the Benadryls and --

10 MR. MARTIN: Right, right.

11 DR. NELSON: -- to homeopathic -- did

12 you see a shift at all?

13 MR. MARTIN: Yes, yes, there was a

14 definite shift over to the homeopathic products,

15 specifically for the kids, in the kid's arena,

16 around the cough/cold. Yes, correct.

17 MR. PACE: Yeah, this is a quick

18 question. Is there any data to show that the

19 specific location on the shelf, including

20 proximity to a non-homeopathic drug product

21 affects consumer behavior?

22 MR. MARTIN: You know, I think when the



224

1 consumer goes to the shelf -- and there, I mean

2 there are industries that don't do anything but

3 try to figure out what consumer behavior looks

4 like. At the end of the day though, most of those

5 consumers are looking -- they're looking to solve

6 for some kind of symptom, and virtually every

7 retailer is going to merchandise their products

8 based upon solving for some kind of minor

9 inconvenience.

10 So I think if you're talking about an

11 antacid, you're going to have all the antacid

12 products together. If you're talking about some

13 kind of eye itch relief or whatever, you're going

14 to put them all together. The items in the over

15 the counter arena are so small, that if you try of

16 the merchandise separately or someplace else,

17 chances are a consumer is not going to find them,

18 or just be confused about your presentation of

19 product.

20 DR. WHYTE: Mr. Martin can we still send

21 our Walmart complaints to you or do we have to

22 send them to somebody else, because I want to know



225

1 how to get them to the president. I have some

2 issues.

3 All right. So now we're going to hear

4 from Patrick Gibbons from Emerson Healthcare

5 Group. Patrick Gibbons

6 MR. GIBBONS: Good afternoon. My name

7 is Patrick Gibbons. I'm vice president and

8 founding partner of Emerson Healthcare. I am here

9 representing my own company and not any other

10 company. A little bit about my company. We were

11 founded in 1994. We built this company to help

12 midsize brands compete with multinational

13 companies in the health, nutrition, and OTC space.

14 Our goal was to give these companies a

15 tool that allows them to interact with the

16 nation's brick and mortar retailers with the same

17 sophistication and professionalism as the large

18 multinationals. Some of the examples of the types

19 of retailers that we call on are retailers like

20 Walmart, Target, Kroeger, Walgreen's, CVS, and

21 Rite-Aid. There are many others, but this is a

22 fair representation of who our sales force is



226

1 built to respond to.

2 Along with sales representation

3 services, through the years our company has added

4 on divisions. One of those divisions is marketing.

5 The other is the one that I lead, distribution and

6 logistics. Through our 20 years in business, we

7 discovered early on that any company that wishes

8 to compete in our space needs to represent not

9 only traditional OTCs, but also should have a

10 presence in the segments of homeopathic care, as

11 well as vitamins and supplements.

12 Homeopathic drugs have grown to become a

13 significant segment of the self-medication brands

14 we represent. One of the most important things

15 for our continued success is our ability to

16 maintain a flawless reputation with the retailers

17 that we call on. Because of this, we are

18 extremely selective with the brands that we allow

19 our company and our sales people to represent.

20 Our promise to the consumer and

21 retailers is access to safe and cost effective

22 self-medications. Because our reputation is so



227

1 important to us, we research the brands we

2 represent. A key part of that is our company's

3 study of the drug product ingredients, indications

4 for use, and published consumer studies.

5 Along with that, we rely on the

6 regulatory processes that already are in place

7 with our potential partners. The research does

8 not end at that stage. Once we have a brand in our

9 portfolio, we continue assessing it. One of the

10 ways we can do this is through analyzing

11 repurchase behavior.

12 This is important because repurchase

13 behavior is the only measurement we have at our

14 disposal to understand if the consumer actually

15 values the product they're purchasing. Our

16 homeopathic medicine portfolio, roughly 8.7

17 percent share of our total business, compares very

18 favorably with some of the major national OTC

19 brands, like Tylenol Cold, Mucinex, Alka-Seltzer,

20 and Visine, just to name a few.

21 For our company, this metric is a

22 validation of the product's importance to the



228

1 consumer. So not surprisingly as we saw with

2 repurchase rates, homeopathic medicine plays an

3 important role and have a significant market share

4 in some of the biggest OTC categories like

5 cough/cold and pain relief, as well as the

6 children's categories within those and other OTC

7 segments.

8 Fueled by the repurchase rate and the

9 retailer's belief in the importance of this

10 medicinal choice, homeopathic drugs continue to

11 grow at retailer's shelves and just as

12 importantly, within the medicine chest of the

13 consumers, due to high satisfaction and increased

14 demand.

15 The homeopathic drug brands that we

16 represent respond favorably to consumer and

17 retailer expectation. More importantly, they

18 provide consumers access to safe, cost effective,

19 high quality choices. They are an integral part of

20 our business model for those reasons. Thank you

21 for your time and attention. Now may be a good

22 time for questions.



229

1 DR. NELSON: Where's John? He

2 disappeared.

3 MR. GIBBONS: I'm flying solo up here.

4 I was flying solo.

5 DR. NELSON: So I have a question about

6 the data on your repurchase rates.

7 MR. GIBBONS: Can you start over? I

8 didn't hear the beginning part.

9 DR. NELSON: On the slide that you

10 presented about the portfolio with the repurchase

11 rates. So I have two questions. One is how you

12 know -- and I'll give you both questions -- how do

13 you know that it's a repurchase. So in other

14 words I came in today and then three months from

15 now I buy it again. I'm assuming that if you can

16 answer that, I assume you know it because you've

17 got (inaudible).

18 And if you have the answer to that, then

19 you could answer the next question which is it

20 would be interesting -- at least I would be

21 interested to know how many of these purchases of

22 say homeopathic products are in conjunction with



230

1 other products? Because I've heard a lot of

2 practitioners say that they do combine various

3 modalities.

4 MR. GIBBONS: They do.

5 DR. NELSON: And so I'm wondering if

6 consumer behavior also combines various modalities

7 or are these unique purchases of homeopathic

8 products?

9 MR. GIBBONS: No. So I'll answer the

10 second question first, and I do have an answer to

11 the first question. So the vast majority of them

12 are in conjunction with other self-medication

13 products. So I don't have the exact amount, but

14 it's above 80 percent.

15 Where we get this data; we can get it

16 from two different sources. One source is A.C.

17 Nielsen, and they have a subscriber list of

18 125,000 panelists who, whatever they buy, be it

19 from Home Depot, be it from Target, Walmart, they

20 scan it when they get home. So we really know who

21 that consumer is and exactly what they're

22 purchasing and they actually have some secondary



231

1 and primary analysis built into that. So it's

2 really rich data.

3 The other way that we can get that is

4 through direct through the retailers. They have

5 these loyalty cards now. So you really get an

6 understanding for who's buying what. But this

7 specific chart came from A.C. Nielsen.

8 DR. MCMEEKIN: Thank you for your

9 presentation. I have one question in regards to

10 your first promise to consumers and retailers that

11 states access to safe, cost effective, self-

12 medication to consumer choice. What information

13 do you rely on to actually fulfill this promise?

14 MR. GIBBONS: So what we're doing is

15 we're going out and we have a network of

16 relationships with manufacturers. A lot of times

17 companies are working in concert with

18 manufacturers. So we have the relationship with

19 the actual manufacturers who are manufacturing the

20 products. And we have a 20-year relationship with

21 the buyers, and our place in the industry is we

22 are sitting at every retailer in the nation, brick



232

1 and mortar, in the three categories that we

2 represent for represent for retailers: food

3 stores, drug stores, and mass merchants, and we're

4 in each one of those at least once a week.

5 So there's a lot of sitting in lobbies,

6 talking to people and understanding what's going

7 out there in the marketplace and we use that

8 experience to see which manufacturers that we want

9 to partner with and it's a very strict filter,

10 because again, our reputation is everything, and

11 once we are satisfied that we've researched as

12 much as we could, we build a relationship. It

13 doesn't end there. We keep an eye on the business

14 as we're representing it as well.


16 MR. GIBBONS: You're welcome.

17 DR. WHYTE: I apologize for not being

18 here, but you're going to do well without me. I

19 was managing the lost phone issue. It turns out

20 it was from someone at another meeting. How it

21 got in this room, I do not know. Maybe they just

22 thought there was so much fun and activity going



233

1 on here, they had to come by and in all their

2 excitement they dropped their phone and -- but we

3 used forensics here at FDA to figure out who's it

4 was and it's been successfully returned to its

5 owner.

6 So at this time we'll turn to Gary

7 Kracoff from Johnson Compounding and Wellness

8 Center. Gary Kracoff

9 DR. KRACOFF: Hello. My name is Gary

10 Kracoff and I thank you for giving me time to

11 speak today about homeopathic product regulation.

12 You've heard from a number of medical doctors so

13 far. I may be the first retail pharmacist to

14 offer testimony today.

15 I'm a registered pharmacist with a

16 doctorate in naturopathic medicine. I'm a past

17 president of the Boston Association of Retail

18 Druggists and a Board member of both the Mass

19 Independent Pharmacists Association, and the

20 Massachusetts Pharmacists Association. I am a

21 member of Boiron USA Pharmacists Advisory Counsel.

22 Additionally, I am a faculty member of



234

1 the Center of Education and Development of

2 Clinical Homeopathy and the Academy of Integrative

3 Medicine. My travel here is being reimbursed by

4 the AAHP, but the perspective I'm sharing is mine

5 and my customers.

6 Community pharmacy and helping people

7 has been part of my life since I was born. My

8 dad's a pharmacist and my parents bought a

9 community pharmacy three months before my birth.

10 It has been a big part of my entire life. It was

11 my first job. It's my career and it has been my

12 passion.

13 Since I got involved in the more

14 holistic side about 30 years ago, I have never

15 been more professionally and personally satisfied.

16 My philosophy is to the treat the person as a

17 whole, not to chase symptoms. I focus on finding

18 the why to what's happening physically and

19 mentally and to work with individuals to restore

20 balance in their body.

21 I first became familiar with homeopathy

22 in high school at my parent's pharmacy. It



235

1 carried homeopathic medicines in the health and

2 beauty aids department. It was in the 70s and

3 customers were using homeopathic products for

4 upset stomach, PMS, mild diarrhea, teething,

5 colic, and headaches.

6 While in pharmacy school, I learned the

7 history of homeopathy and it was at that point I

8 started my formal study of homeopathy and

9 naturopathic therapies. A milestone in my

10 discovery of the value of homeopathy came shortly

11 after the birth of my daughter.

12 The pediatrician had recommended

13 ibuprofen for a fever she had of viral origin.

14 Ibuprofen for infants had just been approved and

15 with my knowledge from pharmacy school of how

16 ibuprofen may affect the liver and my daughter

17 only being a few months old, I hesitated giving it

18 to her. I discussed my concerns with the

19 pediatrician and we agreed to try a homeopathic

20 blend for the fever.

21 We agreed that if the fever didn't break

22 within a few hours, I would start the ibuprofen.



236

1 The homeopathic medicine worked and the ibuprofen

2 was not needed and I was a very satisfied

3 consumer. I find my customers and patients have

4 equally favorable opinions about homeopathic

5 products.

6 Many have relied on them for years,

7 often being used by their families for

8 generations. Most practitioners I come in contact

9 with either embrace homeopathy or feel it will do

10 no harm, so they're open to its use on acute,

11 self-medicating issues.

12 Currently in my practice, I find that my

13 clients from parents with young children through

14 senior citizens are coming into the pharmacy

15 looking for a medicine that will be supportive,

16 that will not interact with medication they are

17 on, and it will have minimal side effects.

18 Mothers are asking for homeopathic

19 suggestions for teething, minor coughs, bumps and

20 bruises, colic, allergies, and stuffy noses. They

21 find homeopathic medicines are easy to dose, taste

22 good, do not cause side effects, such as



237

1 drowsiness or make the children hyper and they

2 feel these products work very well when the proper

3 medicine is selected.

4 Having homeopathic medicines available

5 is also helpful for many different groups of

6 clients that frequent my pharmacy. The more

7 mature person, people with high blood pressure,

8 glaucoma, prostate issues, that have a cold or

9 allergies are frequently coming in looking for

10 assistance on what medicine they can take for

11 their symptoms that of the runny nose and the

12 sneezing.

13 Most OTC products are contraindicated

14 for these conditions, so people are left

15 suffering. Homeopathy offers medicines that can be

16 taken for colds, sinus congestion, and allergies,

17 and does not interfere with other medications or

18 conditions mentioned above.

19 I'd like to take a moment to address

20 your question on data sources. The ones I use

21 more frequently and recommend to my clients are

22 the Materia Medica, Pharmacology and Homeopathic



238

1 Materia Medica from the CEDH, the Family Guide to

2 Homeopathy, the website from the National Center

3 of Homeopathy who is present at this hearing, and

4 Boiron's Medicine Finder, which coming into the

5 21st century is available as an app. It's also on

6 the computer and it's very good for acute care to

7 help put together the right remedy for what is

8 going on, and also recommend when you should see,

9 not self-treat, and move forward to your

10 physician.

11 I plan to submit written comments that

12 will include more details on each of these.

13 Information obviously is what it takes for

14 consumers and healthcare providers to make

15 informed decisions about medicines labeled as

16 homeopathic. I feel they do have adequate access

17 for information on homeopathy and how to determine

18 the proper medicine.

19 Anecdotally, I find there's more

20 confusion with pharmaceutical products,

21 specifically many consumers assume the shift of an

22 Rx to an OTC product means the product is safe and



239

1 doesn't have side effects. Most customers I have

2 found do not read the caution or dosage

3 information on these products. They feel since

4 they're a lower dose than the prescription form,

5 they can even increase the dose higher than

6 labeled and there won't be any problems; they can

7 disregard the cautions.

8 A comment I hear often is that if there

9 were serious side effects, these medications

10 wouldn't have been transferred to the OTC status.

11 I've found that by having homeopathic products

12 available, I'm able to help clients integrate

13 supportive therapies such as diet, lifestyle,

14 stress reduction, which are all necessary for

15 better health.

16 Homeopathy is one of the reasons people

17 come into the pharmacy to ask questions about

18 their health. This opens up the door for a good

19 open discussion about what is going on and what

20 medicines they're taking, what their diet is,

21 their exercise routine, and then help them

22 understand they need to be part of their own



240

1 healthcare.

2 They don't just come in, buy a

3 homeopathic product and take it. This is changing

4 the paradigm, leading to excellent results for my

5 patients for a few simple reasons. They're

6 informed. They're often researching before

7 purchasing. They're coming into the pharmacy to

8 ask questions about a homeopathic medicine, which

9 medicine and dosage and potency they should take.

10 They're getting more than a medicine.

11 They're getting help with their lifestyle, diet,

12 drug interactions, due to the fact that they came

13 in and opened up a dialogue, rather than picking

14 up a product they heard about on TV and walking

15 out with it without talking to anyone.

16 An area I feel the FDA needs to enforce

17 is the improper use of the word homeopathy, mostly

18 by -- I'm seeing my direct marketers and Internet

19 marketers. There are some companies that are

20 labeling natural products as homeopathic products.

21 These companies are using homeopathy to mean non-

22 pharmaceutical and this is really misinforming the



241

1 public.

2 I feel strongly in integrating many

3 modalities in healthcare: pharmaceutical,

4 homeopathy, herbal, nutritional, exercise,

5 lifestyle, acupuncture, chiropractic, and

6 mind/body to be used alone or in combination.

7 This leads to an increase in a person's health, an

8 increase in the quality of their daily living, and

9 lowering healthcare costs down the road.

10 By doing this, the medical profession

11 will be following the thoughts of the Hippocratic

12 Oath. "I will prescribe a regime for the good of

13 my patients according to my ability and judgment

14 and never do harm to anyone."

15 By having homeopathic medicines

16 available at the pharmacy for consumers and

17 doctors, and I can help clients with acute

18 problems to help them get healthier and do no

19 harm. Thank you very much for your time and I

20 welcome your questions.

21 DR. WHYTE: Thank you very much, Gary,

22 for that perspective. Let's start with Richard.



242

1 DR. LOSTRITTO: Thank you. Interesting

2 presentation. I'd like -- in terms of homeopathic

3 products, one of the things that's very important

4 as has been coming out, is the actual dilution and

5 some products are available in different diluted

6 forms. I'd like to ask you as a pharmacist and in

7 understanding compounding, because it's part of

8 your logo -- understanding compounding and

9 manufacturing as you do, are you completely

10 confident that the methods of manufacture

11 consistently and accurately give the dilution

12 that's stated in the labeling?

13 DR. KRACOFF: I am. And the reason

14 being, one, I've been to a few of the companies.

15 I went down, one I asked them, one invited me, to

16 see the manufacturing process and I was really

17 amazed at the bar is here, what's required and

18 they're going over and above.

19 I can only speak for the major

20 manufacturers. I know there's a bunch of -- I'm

21 not sure if there's a bunch -- there's probably

22 companies that I don't carry in the store and that



243

1 I don't recommend. I only recommend products that

2 I feel are made and follow all the regulations.

3 We do things above board at the pharmacy

4 and there's a lot of products we won't carry in

5 the store, allopathic and on the holistic side,

6 because the science isn't there and the quality

7 doesn't seem to be there. So yes, whether -- if

8 it's a 6X or labeled a 30C, I do believe that they

9 are made properly.

10 DR. NELSON: Just based on your name, I

11 was wondering, are you doing any formulation or

12 compounding of homeopathic products at the request

13 of homeopathic practitioners, or are all your

14 products commercially available that you stock?

15 DR. KRACOFF: All the products that we

16 sell or dispense are commercially available. And

17 the main reason is to do the dilution -- if you go

18 round to one of the companies and look at how to

19 make a 30C dilution, it's a very intense process

20 that takes a lot of time. And so, one, quality

21 control wise, you have to be set up to do that,

22 and we're a compounding pharmacy also, but we're



244

1 not set up for that, so we don't do that.

2 Secondly, on a cost basis, if you're not

3 a homeopathic manufacturer it would be cost

4 prohibitive to start making an odd dilution here

5 and there. So it's a lot easier to go to one of

6 the top companies and have -- the product is

7 already available. Why reinvent the wheel?

8 DR. LOSTRITTO: I'd like to follow up,

9 if I may. You mentioned 30C. How many ways are

10 there to make a 30C preparation that you could

11 think of? Because when I think about that, there

12 are probably 30C ways to do it. And I'm wondering

13 if there are standard protocols, but it would

14 require a great deal of sophistication to do that

15 consistently and accurately. Depends how many

16 steps you take and I'm just wondering what you can

17 tell me about that?

18 DR. KRACOFF: Not being a manufacturer,

19 I can only talk from my personal knowledge, but

20 from my education and seeing them actually made,

21 there are I believe two major ways to make them,

22 the Korsikovian and the Hahnemanium (ph) method.



245

1 The main difference is that do you reuse

2 the vial that you're diluting it in, or do you --

3 a 30C would use 30 different vials and take one

4 part of it and keep diluting it down. But it is a

5 -- it's set up in the HPUS how this is done, and

6 the major manufacturers do follow that. Just keep

7 doing it over and over and over it again, diluting

8 it down.

9 DR. LOSTRITTO: Since we still have some

10 -- I still see a green light. So when you compare

11 those two methods, as a pharmacist you know that

12 if the material surface active or absorbs to

13 glass, these two methods can give you different

14 and predictable carryover errors. So I'm

15 wondering if that's done as part of any

16 validation, that intermediate steps. Granted at

17 30C you're not going to be able to detect

18 anything. But at the initial dilutions to check

19 for that, I wonder if that is done on a routine

20 basis, as far as you know?

21 DR. KRACOFF: My personal opinion on

22 this is up to a 30C either method -- and what I've



246

1 seen from the retail and the pharmacy setting,

2 that the activity seems to be the same on the

3 dilutions -- the Xs right up to 30C. There's been

4 a little bit of discussion going above 30C.

5 Usually the next dilution is 200C, that there

6 could be a difference between the CK and the CH.

7 They're both active and effective, but depending

8 upon how you look at it, some practitioners find

9 that there is a little bit of a difference of

10 activity between the C and the K, but both are

11 effective. Thank you.

12 DR. WHYTE: Okay. At this point in

13 time, I recognize Dr. Peter Fisher from the Royal

14 London Hospital for Integrated Medicine. Peter

15 Fisher

16 DR. FISHER: Well, thank you very much

17 for inviting me. It's a pleasure and honor to be

18 here. Before I go any further, I should tell you

19 that my travel and my time is compensated by the

20 AAHP. So I'm clinical director and director of

21 research at the Royal London Hospital for

22 Integrated Medicine in London, England, so I just



247

1 -- not Ontario, Canada, which is the largest

2 public sector hospital for integrated medicine in

3 the European Union.

4 It's part of University College London

5 Hospitals NHS Foundation Trust, which is one of

6 our leading academic medical centers, has eight

7 hospitals, specialist hospitals, with various

8 academic institutes.

9 I'm a fellow of the Royal College of

10 Physicians. I'm also a fellow of the faculty of

11 homeopathy. I'm an accredited specialist in both

12 rheumatology and in homeopathy. I'm also a member

13 of NIHCE. NIHCE is the National Institute for

14 Health and Clinical Excellence. It's an official

15 body in the U.K. which makes recommendations on

16 healthcare; has no official power, but actually a

17 great deal of informal power.

18 I'm also a member of the World Health

19 Organization's Traditional and Complementary

20 Medicine Expert Panel, which has recently

21 published a strategy. There is now a T&CM,

22 Traditional and Complementary Medicine Strategy



248

1 for 2014 to 2023, which I commend to you. A most

2 interesting document. If you only read one thing,

3 read the Director General's forward. Very

4 strongly positive, very strongly indicating the

5 potential of this whole field for healthcare.

6 I'm also editor of the International

7 Journal of Homeopathy, which is the -- well for a

8 long time was, I believe it's no longer the case,

9 for a long time was the only Medline listed

10 journal of homeopathy. However, the only part of

11 my background that you Americans are really

12 interested in is that I'm also a physician to Her

13 Majesty the Queen. I'm afraid it's the only one

14 that seems to impress anybody on this side of the

15 ditch.

16 Anyway, I've practiced homeopathy for a

17 long time, since 1977 and I practice in a fully

18 integrated manner. I am, as I said, a specialist

19 in rheumatology and in homeopathy, so I take a

20 full case history, I conduct physical examination.

21 I'm in a very big medical center; I can order MRI,

22 scans, any kind of scan I like. I have all these



249

1 things at my disposal. So I make a diagnosis and

2 recommend appropriate treatment which may be joint

3 replacement.

4 However, actually I spend a great deal

5 of my time advising patients on their conventional

6 medication, but how to reduce it. As the panel,

7 I'm sure is aware, polypharmacy is a huge threat

8 to public health, particularly in terms of

9 antimicrobials, and homeopathy has something to

10 offer that. There is good evidence of reduction

11 of the use of antimicrobials associated with the

12 use of homeopathy.

13 And in my personal practice, that's what

14 I spend my, what I use my conventional

15 pharmaceutical knowledge, is getting people off

16 drugs, which is much more difficult than starting

17 them. So my personal experience over many years

18 is that the use of homeopathy in a fully

19 integrated manner is safe and effective and the

20 patients very frequently report benefit,

21 particularly in terms of general well-being.

22 That it's useful to treat what we call



250

1 effectiveness gap treatment conditions. These are

2 the conditions for which there a lack of effective

3 treatments, and patients with complex, multimorbid

4 conditions and adverse drug effects. Those are

5 the areas we specialize in.

6 And our patient outcome surveys show

7 that most patients who attend a hospital report an

8 improvement sufficient to make a difference to

9 their daily lives. And one of the other

10 interesting things, the independent surveys show -

11 - although we're a very small hospital, we are

12 just about the best in terms of patient feedback

13 in the entire 5,000 hospitals in the National

14 Health Service. We are number one or number two,

15 depending on who you believe.

16 So just to take some of the specific

17 questions that were raised in the Federal

18 Register. So the first thing about consumer and

19 healthcare provider attitudes. Throughout the

20 European Union they are generally favorable.

21 Indeed, probably more favorable in France and

22 Germany say than in the U.K., but in the U.K. OTC



251

1 sales of homeopathy are growing at somewhere

2 between 10 and 12 percent annually. It's 98

3 percent of French pharmacies, essentially all

4 French pharmacies stock homeopathy.

5 Lifetime use in the French population is

6 around 50 percent. In Germany, Netherlands,

7 Belgium, several other Western European countries,

8 you have numbers around 30 to 40 percent.

9 Yesterday the question was raised, is there any

10 country that bans homeopathy?

11 Well, Honduras was mentioned, but there

12 was one country in Europe, in the heart of Europe

13 that did ban homeopathy, and that was the GDR, the

14 German Democratic Republic; that's East Germany to

15 you, which ironically is the country of origin of

16 homeopathy. It was banned. It was banned in East

17 Germany. Of course, that changed very quickly

18 when the two Germanys reunited.

19 But throughout Eastern Europe,

20 homeopathy, while it may not have been officially

21 legal, was strongly discouraged and they had

22 strong extra legal methods of discouraging things



252

1 in those countries, and it has bounced back

2 dramatically. A 40-year hiatus when it was

3 virtually absent, because it was non-materialistic

4 as the Communists didn't like it.

5 It has bounced -- in Poland now. I was

6 in Poland quite recently, they have 30 percent

7 use. Throughout Eastern Europe it has -- when

8 people have the option to use it, they do use it.

9 So that's the attitude of consumers.

10 Healthcare providers generally like

11 homeopathy and particularly insurers. And one

12 reason is, as I'll mention in a moment, actually

13 the cost effect -- comparative effectiveness data

14 shows that integrating homeopathy with

15 conventional treatment gives you better outcomes,

16 safer outcomes, for the same cost.

17 But there is also a slight hidden agenda

18 here. The insurers also like homeopathy, because

19 it is associated with healthier lifestyles.

20 Consistently, in France and Germany, a number of

21 surveys have shown that people who use homeopathy

22 are less likely to smoke, less likely to be



253

1 overweight, higher educational levels

2 interestingly. This is pretty consistent finding.

3 And of course -- and also more positive attitudes

4 to self-care, and of course those are all positive

5 characteristics as far as insurers are concerned.

6 They are associated with lower risk, so the

7 insurers like it and I will come to that in just a

8 moment.

9 So the second question concerns data

10 sources. Well there is quite recently a very,

11 very valuable data source called CORE-HOM. That's

12 C-O-R-E- hyphen-H-O-M. Put that in Google, you'll

13 find it straightaway. This is a comprehensive

14 database of clinical research in homeopathy

15 maintained by the Carstens-Stiftung -- the

16 Carstens Foundation.

17 Carstens was the president of West

18 Germany in the 1970s and endowed this foundation.

19 I checked this morning. It currently has 1,117

20 clinical trials of homeopathy -- the records of

21 1,117 clinical trials of homeopathy of which I

22 believe 298 are full reports of randomized



254

1 clinical trials. So it is simply not true that

2 there is no evidence.

3 Just to cherry pick the research that's

4 in there, some of the most interesting areas for

5 me are the comparative effectiveness research.

6 There's a couple of studies done by David Riley

7 who was speaking a couple of hours ago. I think

8 he's gone now. Just as well too -- I hate -- you

9 know he might tell me I'm getting it wrong.

10 But David Riley led a couple of very

11 interesting comparative effectiveness studies.

12 One was in six clinical sites in four countries

13 with 30 doctors, 456 patients, in acute

14 respiratory infections showing improvement at two

15 weeks was 83 percent for homeopathy and 68 percent

16 for conventional treatment, and a much lower,

17 dramatically lower rate of adverse effects, 22

18 versus 7.

19 And they then repeated it with 1,500

20 patients with very congruent results.

21 Essentially, you had quicker recovery, with fewer

22 adverse effects. But this is, of course, doctors



255

1 who were using antibiotics as required, but not

2 just chucking antibiotics willy-nilly at

3 everybody.

4 A rather similar study done in France.

5 In France, it's feasible to do these studies,

6 because you have significant numbers of family

7 physicians who are accredited. The French love to

8 accredit people. They're very -- you can look it

9 up in the yellow pages who's accredited in

10 homeopathy.

11 So you can be -- but you can be sure

12 that these guys are trained in homeopathy. They

13 looked at homeopathic strategy versus antibiotic

14 strategy in children; in children with a recurrent

15 upper respiratory tract infections, big problem,

16 and again showed big, big improvements in favor of

17 homeopathy.

18 Perhaps the most striking one was the

19 very large reduction in the number of antibiotic

20 prescriptions and also improvement in quality of

21 life. This is quality of life of the parents

22 actually, not of the children, and anybody who has



256

1 had a child with acute otitis media knows it

2 doesn't do much good for your sleep.

3 And then the biggest single comparative

4 effectiveness study is still -- the papers are

5 still being published, it's called EPI3. Again,

6 in France, nationwide study done in France led by

7 the Department of Pharmacoepidemiology at the

8 University of Bordeaux, over 6,000 patients, 800

9 medical practices, and a number of cohorts

10 including musculoskeletal, upper respiratory tract

11 infections, and minor psychiatric things, anxiety,

12 depression and sleep.

13 Only two have been published so far,

14 which is the musculoskeletal cohort, showed again

15 this interesting finding that the patients who

16 sought -- and they did seek, this is not

17 randomized, they did seek homeopathy, they went to

18 homeopathy, they were less likely to smoke, they

19 were less likely to obese, and they had a higher

20 educational level than other people who went to

21 standard family physicians, but they had more

22 chronic disease. They were actually worse



257

1 affected.

2 And the results in terms of both acute

3 and chronic musculoskeletal problems were very

4 similar, except that the group who got homeopathy

5 got about half the NSAIDs, half the non-steroidal

6 anti-inflammatory drugs. This is a very dangerous

7 group of drugs, as you know, major cause --

8 everybody knows about the gastric bleeding, but

9 the renal side effects are much less recognized

10 and many renal physicians will tell you that most

11 of the people they see with renal failure, it's

12 due to non-steroidals.

13 And a very congruent result with the

14 upper respiratory tract infections; and again,

15 this interesting and I think valuable finding that

16 it reduces antibiotic use because as everybody in

17 the know knows, antimicrobial resistance is a

18 really, really major threat to global public

19 health.

20 So finally, just a question about

21 whether consumers and healthcare providers need

22 more information and the answer I think is a



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1 resounding yes. The study that Michelle

2 mentioned, Michelle Dossett mentioned earlier on

3 this adverse effects of homeopathic medicines, one

4 of the interesting sub-findings of that was that

5 actually 20 percent of the so-called results, so-

6 called homeopathic medicines weren't homeopathic

7 at all. They were herbal. And these were

8 professors; these were academics who should have

9 known better and who were misreporting them.

10 So if the academics can do that, you

11 know, what hope is there for the poor consumers?

12 So there do need to be, we need clear distinction

13 about what is herbal, what is homeopathic, the

14 applicability, and the limitations. And I think,

15 above all, what are the danger signs? When your

16 child is developing meningitis, do not mess about,

17 get straight down to the emergency room.

18 And that information I think, while I'm

19 not the expert on that, but it can be provided I

20 think in the form of labeling, in-pack leaflets,

21 in-store information, online, toll-free numbers,

22 obviously there are a number of possibilities and



259

1 I don't think I'm the right person to say exactly

2 how it should be delivered, but certainly it would

3 be valuable to have more information. And I thank

4 you for your attention.

5 DR. WHYTE: Thank you, Dr. Fisher. Dr.

6 Fisher was referring to me. I asked him, just to

7 clarify, because we have a lot of Canadians here,

8 or at least a few, whether it said London,

9 Ontario, Canada, or London, England. So that was

10 probably comparing like Paris, Texas, and Paris,

11 France, but perhaps I can redeem myself with

12 knowledge that today is a special day? Why? In

13 London?

14 It is Her Majesty's birthday. Correct.

15 It's today at 89 years young, so just like Mr.

16 Mittman's mother; I think you said she was 85 or

17 86, she celebrates her birthday with the Queen,

18 which as you know today is her actual birthday,

19 but she does her official birthday in June, so

20 hopefully I've redeemed myself with a little bit

21 of London, U.K. knowledge trivia.

22 All right. Well, I better let the



260

1 panelists ask their questions and I'll start with

2 Richard. Thank you for saving me, Richard.

3 DR. LOSTRITTO: You were digging

4 yourself in deep. Thank you very much for your

5 presentation. I'd like to ask you, in terms of

6 how things are done in the U.K. with respect to

7 homeopathic products, how are they distinguished

8 from non-homeopathic products that might be vital

9 (ph) medicinals and so forth. Are they

10 distinguished by labeling, by product placement or

11 other means, if you could --

12 DR. FISHER: By labeling. Essentially

13 it's a two-stage process. There are, in fact, two

14 European directives. What they call, in Europe we

15 call them HMPs, homeopathic medicinal products.

16 There's one for human use and one for animal use.

17 So that sets the framework and within that you

18 have national rules. But -- so yes, they are

19 labeled as -- they have various designations.

20 So the ones that are, as they say, in

21 the parking lot, that haven't been through the

22 full process, have what we call PLRs, product



261

1 licenses of right, which means that since they've

2 been on the market for a long time, and there is

3 no evidence of adverse effects, they're allowed to

4 stay on the market. Although, of course, the

5 Ministry doesn't like that and is trying to push

6 them through.

7 And then we have HRs, homeopathic

8 registrations, which is a simplified scheme and

9 that is clearly marked, homeopathic registrator

10 (ph) and the number on the bottom. And then we

11 have marketing authorizations for typically

12 combinations, labels, which have claims.

13 DR. WHYTE: Any other questions? Thank

14 you, Dr. Fisher.

15 DR. FISHER: My pleasure.

16 DR. WHYTE: All right. We are now at

17 our last speaker and the coveted spot goes to

18 Daniel Michels. Daniel L. Michels

19 MR. MICHELS: Thank you, John. I guess

20 we call this saving the least for last. I think

21 John has done a marvelous job of herding the cats

22 today as well as yesterday, I assume. Thank you.



262

1 My name is Daniel Michels. I represent me. I was

2 asked by folks at the HP Convention to speak to

3 this group and I decided to do so without

4 compensation and thereby preserving my status as

5 being fully retired.

6 I was a lifer at FDA in the previous

7 millennium. It is not true that I advised Dr.

8 Copeland on the legislation. I'm not quite that

9 old. I started as an investigator at FDA many

10 years ago. On point for today, I was director of

11 the Office of Compliance in CDER for 10 years,

12 during which the CPG came about, and finished my

13 career as director of the Office of Enforcement at

14 the Agency, and then spent about 14 years as a

15 consultant.

16 I'm sort of repackaging I think what

17 you've heard today, but maybe with the spin of the

18 person who was there when it happened. I think it

19 is important to understand why was a CPG needed in

20 the first place, and why does it have this

21 particular construct.

22 1980s, holistic healthcare, I don't know



263

1 what the proper PC term is, but there were a lot

2 of things that were happening and growing and

3 changing in our society, in healthcare, that we

4 had not experienced before and FDA was no

5 different from others in terms of trying to figure

6 this out, grapple with it, absorb it, and to the

7 extent that it needed some herding back into the

8 line doing that in the right ways.

9 Part of that clearly was a new growth in

10 homeopathy. We in the compliance area thought

11 that this was something we'd never have to worry

12 about. It was dying, forget it, it'll be gone by

13 the time we retire. Not true.

14 What first came to my mind in terms of

15 thinking about our regulatory problems were

16 homeopathic products in combination with others.

17 Fill in that blank. And what do we do with this

18 as regulators and working with our folks in the

19 general counsel's office, what are these things?

20 Easy defense, they're homeopathic.

21 Don't mess with them. Well, not quite an

22 acceptable way of dealing with it, but we didn't



264

1 know what homeopathic products were. No

2 expertise, nobody in-house that we could go to.

3 A number of homeopathic products were

4 being offered for clearly health fraud conditions,

5 cure your cancer, fix your broken leg, fill in all

6 of the blanks that are classic for the health

7 fraud that this country and maybe society has

8 experienced for the last 200 years. Some of those

9 things haven't changed.

10 At the same time, my staff was busy

11 dealing with the drug efficacy study

12 implementation, dealing with the downside or the

13 ending parts of the '62 amendments, but as you've

14 heard there's still some pieces left over, and

15 then really working hard on implementing the OTC

16 drug review. As the monographs rolled out, we had

17 to make sure that the marketplace conformed. Big,

18 big job.

19 Anybody remember what happened in 1982

20 from -- might have impacted on FDA? Tylenol

21 tamperings. 1986, product tamperings. Take

22 Tylenol and spin that over to IV needles in Pepsis



265

1 and you name it. We had a lot of work that needed

2 doing and homeopathy and regulating this class of

3 product didn't seem to be rising to that level.

4 But nevertheless, we still had problems

5 of folks doing the wrong things, at least on their

6 face, in that particular industry. So what do we

7 do? We had a knowledge gap as I characterize it.

8 We didn't know what homeopathic products were.

9 They were whatever the HPUS said they were and we

10 didn't -- where do we find one; does the library

11 have a copy? That's sort of at the level that we

12 were.

13 Where, how were they produced and by

14 whom? What were official homeopathic products and

15 how did they receive official designation? With

16 the USP, obviously we had a lot more experience

17 and a lot closer relationship, or a relationship I

18 guess is the way to put it, as opposed to with the

19 folks at the

20 HPUS.

21 As was touched on, how did OTC and Rx

22 designations apply to homeopathic products? Don't



266

1 know. We kept trying to apply what we thought

2 were the rubrics that didn't quite fit. And how

3 were they labeled? Didn't know. Didn't know any

4 of this. So we needed to close the gap. Somehow

5 figure this business out.

6 I think the first thing was recognizing

7 that we could not, in the 1980s, treat homeopathic

8 products with the same regulatory construct that

9 we applied to the other "traditional,

10 pharmaceutical products." We were dealing with a

11 different world.

12 We did, what I call, independent

13 research. I sent folks out. Go figure this thing

14 out. Do your library research. I remember a guy

15 named Joel Davis (ph) that we sent to a

16 homeopathic pharmacy in Bethesda. Go find out

17 what they're doing. And we slowly, but surely,

18 figured out that it was very, very different from

19 what we were used to dealing with.

20 Simultaneously with our concern from the

21 regulatory standpoint, we were approached by folks

22 in the industry and the Convention saying that



267

1 there's stuff going on here that we don't like,

2 going back to the health fraud issue with products

3 of specious origin, specious quality. And what

4 can we do about it? We being depending on how you

5 want to define it -- we the industry, we the

6 community, we FDA, or we altogether.

7 That was the construct, the environment

8 from which the CPG sprang. And my first

9 disclaimer about the CPG, some would say I wrote

10 it. I will confess to having my fingerprints on

11 it. I don't recall -- nothing is singly and

12 uniquely written in FDA. There are a lot of

13 editors; probably more editors than writers.

14 So to the extent that it is a good

15 document, my very good staff in the Office of

16 Compliance contributed that. If it is defective

17 with regard to Rx versus OTC or anything else you

18 don't like, I confess. It is a less than perfect

19 document, but it was the best that we could do at

20 that particular time, recognizing that we did not

21 have a magic wand to wave to solve all of the

22 problems that may have existed in this particular



268

1 class of product.

2 And interestingly enough, and I think

3 you're hearing it, there is some tension between

4 thinking about these products. Should they be

5 here? Under what conditions? That still is an

6 issue that's not fully solved. Maybe it never

7 will be. Thankfully, I'm retired. Good for you

8 folks.

9 There were good things, very good

10 things. We agreed and the industry agreed that

11 homeopathic products should conform to the good

12 manufacturing practices. They're drugs. The only

13 exception that still exists is the one that's not

14 been dealt with, as I understand it, that is final

15 product testing.

16 But all of the other issues, going back

17 to record keeping, from training, education,

18 equipment, all the stuff that is in 211s apply.

19 Labelling issues I think were a catch up

20 proposition. A number of the products had Latin

21 names that were certainly appropriate at the time

22 that they maybe were originally produced and



269

1 marketed, but certainly not up to mid or late 20th

2 century labeling requirements.

3 And the industry and the community took

4 on that challenge and say, Okay, give us time and

5 we'll work it out. As far as I know, that did get

6 worked out. Another part was where's our

7 reference? The HP, the pharmacopoeia itself was

8 not necessarily fully up-to-date. And as a

9 regulator, give me the standard. I can go out and

10 go find under P, that's where I can find the

11 specs, this is how the product is defined.

12 Well, that wasn't as reliable as we

13 would have like it. And consequently, I think you

14 -- if you look in the CPG, there are also other

15 reference materials which are cited there as

16 dispositive in terms of the regulatory status and

17 standards for these products, because there was

18 not a single up-to-date document.

19 But the community committed to making

20 improvements. I'm long gone. I don't know

21 whether those improvements were made, but I don't

22 know that there have been any regulatory problems



270

1 as a consequence of it not happening.

2 From my standpoint then, the consequence

3 of the CPG, it enhanced FDA's ability to take

4 regulatory action when necessary, against products

5 containing or alleged to contain homeopathic

6 ingredients. That is, now we had something that

7 made sense to everybody, at least to the extent

8 that we're able to deal with the outliers. If

9 they were making outrageous claims, if they were

10 mixtures, combination products, we had some

11 grounds that the world had been warned and this

12 was FDA's "line in the sand".

13 Obviously, it did not fully address

14 issues such as the bright line of Rx versus OTC.

15 I would argue that that line sometimes is a little

16 dim in non-homeopathic products when people can

17 get into some heated discussions. But

18 nevertheless, it did not seem to be a big problem

19 and I'm not sure today, whether it is that big

20 problem, if one looks at the universe and the

21 practices of the community. I leave it that to

22 your research as you think about this issue.



271

1 And obviously, it did not address the

2 conundrum, as I characterize it, of homeopathic

3 products not conforming to NDA/ANDA/OTC review

4 conditions. How you work that out, I don't know.

5 Maybe there is no solution. I don't know. I

6 wasn't bright enough to figure that out at that

7 time. I'm still not bright enough to figure it

8 out for you today.

9 But the reality is, to me, the bottom

10 line is what has changed in your regulatory

11 environment, what has changed in the community,

12 the public health arena, which causes us to be

13 concerned that the conditions and the policies by

14 which the Agency has been operating for low these

15 many years, need changing?

16 And I'm not smart enough to know,

17 because I've not been patched in, but I think to

18 the extent that there are changes appropriate,

19 then they become ones of, all right, let's be

20 careful, let's work together, and not have the

21 classic Washington unintended consequences as a

22 result of doing the obvious thing and having it



272

1 blow up in your face.

2 To me, what's not stated in the CPG that

3 was probably the most valuable was the

4 establishment of communication with the community.

5 We didn't have the expertise. We weren't going to

6 have the expertise about what homeopathic products

7 were and all the unique things about them, but we

8 had people to talk to.

9 And I had a compliance officer I could

10 go to and say, figure this out for me, and he'd

11 pick up the phone or call somebody and have a

12 meeting and we were able to work things out so

13 that we understood where the lines were, that this

14 was in fact homeopathic practice, or else, no, for

15 God's sake, please go get them. Whatever the

16 extremes were.

17 It may be useful for you all to be

18 thinking in terms of -- and I'm not endorsing any

19 one particular homeopathic organization, but the

20 Agency has longstanding relationships with -- and

21 I'm going through the alphabet soup of AMA,

22 Pharma, DIA, PDA, USP, fill in all of those



273

1 blanks. It seems to me that this particular

2 element in your regulatory environment needs the

3 same kind of circuitry to be able to talk to them

4 and work together to the extent that that's

5 possible. Thank you.

6 DR. WHYTE: Thank you, Mr. Michels.

7 We'll have five minutes of questions and we'll

8 start with Richard.

9 DR. LOSTRITTO: Thank you, Dan. Good to

10 see you again. You probably don't recognize me.

11 The last time you saw -- if you remember me, I had

12 a full head of hair.

13 MR. MICHELS: We probably both didn't

14 have this part due to Congress. Same source,

15 right?

16 DR. LOSTRITTO: So I was thinking about

17 what you said regarding the 80s and I was

18 professionally active in my second decade in the

19 80s and two things that I would say remarkably

20 different today from then, would be one, the

21 supply chain now is global.

22 It's a global manufacturing situation



274

1 for substances and products, intermediates, and

2 just you know imagine that. And the second is the

3 Internet, in terms of global information transfer

4 and also another source of product. And I'm

5 wondering if you could just give us a brief

6 opinion of how you think these things would impact

7 a revision to the guide today?

8 MR. MICHELS: My knee-jerk reaction is

9 that the Internet is a subset of the international

10 problem or issue, because you don't necessarily

11 know where that information came from or who's

12 maintaining that website. It sort of real -- to

13 me, it's -- I'll get to the international part,

14 but the Internet to me is like my health fraud

15 staff having to deal with people shifting post

16 offices and changing the names of their entities

17 within the United States. That was hard enough to

18 deal with back then.

19 But now with regard to people ordering

20 things off the Net and blithely assuming, because

21 it looks good and the price is good, then it's

22 okay. Then it -- clearly, it is a much different



275

1 game. I commend my successors in terms of their

2 attempts to wrestle with the Internet in that

3 regard in terms of strange products or products

4 that are not reliable.

5 The international part is absolutely

6 dead on and I think the strategies that the Agency

7 has already undertaken with regard to working with

8 other governmental entities, expanding and

9 intensifying, are the right things to do. The

10 ultimate problem, I think, will be leveraging the

11 regulatory resources.

12 Go back to the fundamentals. You

13 haven't got enough FDA investigators to cover what

14 you have domestically, stretch them around the

15 world. Then the question becomes one of how can

16 we deal with our counterparts, be they in the U.K.

17 or Germany or wherever, in order to help prevent

18 that -- or to enhance protection by reducing the

19 probability that bad stuff will get in.

20 So it's a long way around and I agree

21 with you. Those have changed, but I would

22 consider them to be technological changes, but not



276

1 regulatory. Same regulatory problem.

2 DR. WHYTE: That looks like the final

3 question. Thank you for coming back and sharing

4 your perspective and --

5 MR. MICHELS: If I might --

6 DR. WHYTE: Yes.

7 MR. MICHELS: -- make one other

8 observation. Dr. Fisher, where are you? When did

9 you become the Queen's physician?

10 DR. FISHER: 2001.

11 MR. MICHELS: I had the honor and

12 opportunity to talk to your predecessor back in

13 the 80s when we were grappling with homeopathy.

14 DR. WHYTE: Today has been a great

15 source of history of this topic. And Mr. Michels,

16 I am going to use your line later. I'm going to

17 keep it that there's more editors than writers

18 here. That'll come in handy. You know --

19 MR. MICHELS: (Off mic). Closing Remarks

20 DR. WHYTE: Oh yeah, that's true. You

21 know that concludes our meeting in terms of

22 everyone has had an opportunity to present. You



277

1 know I certainly want to thank my colleagues from

2 the FDA, the members of the panel, who I know have

3 spent a significant amount of time reviewing the

4 materials, participating in the past two days.

5 I certainly want to recognize Lesley

6 DeRenzo. Perhaps Lesley could stand. She has

7 done an enormous work with her team and colleagues

8 pulling the meeting together. And Dr. Woodcock

9 could not be here today, but on behalf of Dr.

10 Woodcock, she did want me to express her

11 appreciation and I want to express my appreciation

12 to everyone who came here today and particularly

13 the presenters.

14 We recognize, as I said yesterday,

15 there's lots of things that you could be doing

16 with your time, rather than preparing a

17 presentation, submitting a presentation,

18 requesting time, presenting your talk in a very

19 brief period, and then answering a barrage of

20 questions from very well-intentioned panel

21 members.

22 Our goal today and yesterday really was



278

1 to have a listening session, and I think we

2 successfully were able to do that. And we heard,

3 as all of you have heard from a wide range of

4 stakeholders, whether it was patients,

5 pharmacists, doctors, doctors of homeopathy, trade

6 associations, manufacturers, policy makers; we

7 heard from international perspectives.

8 And that really was our goal over the

9 past two days, to have a true listening session

10 and hear different perspectives as we think

11 through our regulatory framework and our

12 regulatory structure relating to homeopathic

13 medicines. So it's not often that meetings end

14 early. So I think we'll leave it at that and

15 adjourn the meeting. So thank you very much.

16 (Meeting adjourned at 3:49 p.m.)

17

18

19

20

21

22



279

1 CERTIFICATE OF NOTARY PUBLIC

2 I, NATALIA THOMAS, the officer before whom the

3 foregoing proceeding was taken, do hereby certify

4 that the proceedings were recorded by me and

5 thereafter reduced to typewriting under my

6 direction; that said proceedings are a true and

7 accurate record to the best of my knowledge,

8 skills, and ability; that I am neither counsel

9 for, related to, nor employed by any of the

10 parties to the action in which this was taken;

11 and, further, that I am not a relative or employee

12 of any counsel or attorney employed by the parties

13 hereto, nor financially or otherwise interested in

14 the outcome of this action.

15

16

17 __________________________ Natalia Thomas

18 Notary Public in and for the Commonwealth of Virginia

19

20

21

22


Page 1


$$1.5 146:1

$2 133:6

11 35:11 60:3

1,000 84:17

1,070 188:2,7

1,117 253:19,21

1,159 187:18

1,180 187:1

1,295 106:7

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19 185:15 191:5

1903 98:9

1906103:7,10,14,17

1912 103:13

1918 204:1

1930s 103:16211:19

1934 103:21

1938 104:3 105:16

135:10 170:18180:4

1962 134:4,9135:10

1970 185:15

1970s 253:18

1972 104:12 105:3136:14

1974 100:14 204:4

1977 248:17

1978 83:21 187:17

1980 100:12,15

1980s 83:21 86:289:6 113:17262:22 266:7

1982 58:18 100:21264:19

1985 43:20

1986 264:21

1988 37:22 105:8130:19 131:18136:8 137:4140:5

1992 101:5

1993 148:22

1994 225:11

1995 105:16185:15

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22,000 30:22

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200 40:11 87:12264:8

2000 185:13

2001 276:10

2002 149:1

2004 101:6,7145:22

2006 61:10

2007 190:16

2008 13:10 149:2

2009 59:19 102:7

200C 246:5

2010 187:17

2012 35:12 186:15190:13,19

2013 146:5 179:6

2014 107:16 147:9149:11 248:1

2015 1:11 205:5280:12

2017 107:19 117:5

202 5:9

2023 248:1

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20th 269:1

20-year 231:20

21 1:11 8:10 28:7114:7 179:21

211s 268:18

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Page 2


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300 216:15

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30s 193:19

31 60:3

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4,290-hour 45:10

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400,000 35:12

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40-year 252:2

42 191:22

43 4:7

45 11:5

456 254:13

46 175:5 187:2

48 182:11

486 186:22

497 107:4

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56 204:5

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80s 273:17,19276:13

81 191:9

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86 259:17

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AAP 20:5

ability 62:16 99:17160:11 163:22172:11 226:15241:13 270:3279:8

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Page 3


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abuse 34:16 35:1

academic 71:5247:6,8

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Academy 74:9134:10 234:2

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acceptable 48:3263:22

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accepting 17:2218:7,11

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accessed 101:9

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accurately 120:13242:11 244:15

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acetylsalicylic53:21

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acid 53:21

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acting 9:10

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actives 140:3,22

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actors 116:7

Act's 49:19

actual 53:13138:12 151:4188:7 198:11231:19 242:4259:18

actually 8:1710:19 17:3 18:1025:5 36:20 66:569:15 79:16 94:2123:17 131:2,3133:13 137:13140:17 141:10143:13 145:4147:2 149:4,7152:4 197:6198:14 201:19227:14 230:22231:13 244:20247:16 249:4252:12 255:22256:22 258:5

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adapted 113:8

add 54:11 70:673:2 81:4,6 87:1118:22 119:3196:13 197:22

added 102:6 124:4134:6 150:15188:17 226:3

addendum 180:3

addition 39:1250:3 51:1 72:1776:7 77:21100:13 106:18107:21 139:1169:15 201:5

additional 8:1838:8,16 95:1396:16 107:20112:4,11 140:1143:18 152:1216:10

Additionally233:22

address 22:246:11 52:6 62:2064:1 69:1,18143:9 151:19,20184:5 191:18203:10 216:9


Page 4


237:19 270:13271:1

addressed 132:22

addressing 143:3

adequacy 64:5

adequate 19:1021:3 33:9 63:1877:2 91:11 99:18161:12 183:4207:5 210:22211:11 238:16

adequately 26:634:11 98:3132:22

adherence 112:13

adjourn 278:15

adjourned 278:16

adjunct 18:2019:8

adjuncts 169:20

adjust 210:12

administering22:15

administration1:3 56:20 123:7142:15

Administration's1:8 6:7

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admission 61:19

admissions 35:13

adopted 132:1134:4 137:4140:5 142:10143:19

adopting 136:14

adult 191:6

adulterants 50:1

adulteration48:16 105:20

adults 175:4190:14,20

advance 136:2139:19

advantage 132:6

advantages 24:3

advent 33:20

adverse 48:6,2161:8,13,2162:5,14 63:766:14 136:20182:8 184:14185:3,10,17,18,19187:1,6,10,18,20,22 189:6 192:7197:20 250:4254:17,22 258:3261:3

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advice 47:16129:21

advised 103:2262:7

advising 249:5

Advisory 233:21

advocating 199:1

affairs 2:3,7,206:12 9:15 56:14

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affected 203:1257:1

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affiliated 177:4

afford 204:3

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African 83:12

afternoon 117:15144:21 152:22153:2 168:15178:17 183:12202:5 213:16225:6

afters 212:1

against 30:8 47:16123:20125:10,14 126:5131:3,6,9 132:7140:5 270:4

age 222:21 223:2

ageing 215:7

agencies 176:16178:2,5198:17,22

agency 18:1334:10 59:1161:7,9 62:167:22 68:1689:18 98:10104:20115:3,15,18116:4,9,15,17117:7 123:19125:17130:15,16131:2,7,11,22132:3,9,15133:2,15 134:2135:12,13136:4,12,14137:1,4,7,22138:3,9,20139:7,21

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agency's 58:560:10 68:8 131:8135:3 178:13

agenda 4:2 5:2252:17

agent 69:3

agents 24:6

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ago 21:1 28:860:21 117:19153:11 214:17222:18 223:4234:14 254:7262:10

agreed 235:19,21268:10

ahead 21:1597:13,18 165:4212:17

AHP 177:5

AHPA 58:2,3,8,1859:1,3 61:1563:13 64:765:2,9,12,1766:7 70:5

AHPA's 58:1064:14 66:22

aid 34:20

aided 113:4

aids 235:2

AIH 169:7,10170:21 171:3,22


Page 5


175:14176:2,16,22177:5 178:8183:22 184:13

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ailments 215:1

ails 34:2

Airways 86:7

Al 4:19 129:7,9,12

ala 127:5

Albert 88:19

alert 49:8

alike 92:7

Alka-Seltzer227:19

alleged 270:5

allegedly 138:19

Allegra 219:4

allergic 155:16187:22 191:5

allergies 236:20237:9,16

allergy 28:19219:3

alleviate73:3,12,18 185:9

allopathic 36:1144:12 48:2264:22 65:4 66:474:13 85:11128:20 133:18138:11,15140:9,15 144:2163:6,16 165:20166:2 182:21195:7,18 217:19222:7,20 223:8243:5

allow 7:3 8:559:10 61:9 91:15117:21 118:1151:5 165:4193:2 226:18

allowed 261:3

allowing 202:7

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alone 72:11 81:17102:14 241:6

alpha 159:3

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already 76:1984:16 101:1106:10 116:19124:1,14,15,21171:4,14 181:18227:6 244:7275:7

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alteration 158:20

alternative 13:1734:4 46:272:2,13,19 77:2289:12 157:6173:8 185:5

altogether 267:6

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am 11:14 33:1371:7,12 79:1898:4 115:16128:9 129:13153:3 172:22183:13 194:3202:12 225:8233:20,22242:13 248:18276:16 279:8,11280:4

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amazed 17:3242:17

amenable 48:1050:7

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America 28:4 47:8145:17148:11,22

American 4:10 5:812:22 13:418:21,22 28:829:21,22 35:1143:12,13 57:1958:1 74:9,1476:17 100:10116:7 129:19142:9 151:3168:13,20,21169:6 172:6,22173:1 181:1190:13 191:6201:2 204:21

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among 36:9129:17 131:8146:8 190:20191:16 196:22

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amount 24:1237:14 222:19230:13 277:3

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ampules 186:21187:11 200:17

analysis 26:20

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anaphylaxis155:15

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angioedema155:15

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anomalies 209:5

answer 46:1865:10 75:1385:16 86:18 92:6118:2 161:14162:16,18 165:6166:5,15 167:9229:16,18,19


Page 6


230:9,10 257:22

answered 168:4220:16

answering 277:19

answers 32:785:18

antacid 224:11

anthroposophic186:17

anti 35:6,19 154:5

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antibiotics 29:8255:1,2

antibodies157:19,21158:16159:1,8,13,20161:10 163:4,14164:12,15,17166:21

anticholinergic144:3

anticipated 21:15

antigens 157:22

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anti-inflammatory35:9,17 257:6

antimicrobial257:17

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anxiety 256:11

anybody 140:11248:14 255:22

264:19

anyone 37:19105:5 130:9240:15 241:14

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anything 198:12214:8 224:2245:18 267:17

anyway 95:19149:16 248:16

Anyways 16:18

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APIs 107:9

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app 238:5

Apparently155:16

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appeared 105:2106:14

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approach30:12,15 49:2071:21 81:2 82:284:11 125:6132:11 134:18135:1,8 137:2138:14 139:20202:1 213:5217:18

approached266:21

appropriate 21:1139:14,15 44:2247:4 60:6 61:575:11 88:22 95:5102:17 111:8114:9 124:7126:4 137:8142:18 163:18206:20 249:2268:21 271:18

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approval 40:20106:12 112:2134:7 139:16

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approximately13:11

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arboreal 67:5

architecture197:11

archived 211:21

area 13:14 24:2,1068:15 114:22128:12,15,16182:19 193:16207:9 214:4240:16 263:10

areas 22:13 47:5101:18 125:15139:21 150:2181:8 250:5254:4

arena 223:15224:15 271:12

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arsenal 87:2

art 134:1

artfully 141:14

arthritis 33:18

article 35:10

articles 74:6,8104:10 147:21

aspect 15:8 126:21


Page 7


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assay 160:8

assemble 179:7

Assembly 166:10

asserted 130:20

assess 18:14 76:1281:11,14 89:18193:11

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assessing 227:9

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asset 178:9

assistance 237:10

assistant 2:6 12:270:22 169:1173:3

assistants 169:14

associate 9:1012:5

associated 35:1661:8,13 62:1485:10 107:1124:15 136:20159:4 249:11252:19 253:6

association 4:1018:21 43:10,1345:6 57:1958:2,9 69:2083:12 116:8129:19,20

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attitudes 15:1232:1 75:15 85:2088:5 205:11250:19 253:3

attorney 279:12

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audio 152:4,9,11

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augment 63:9170:3

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author 27:21187:14

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187:17 189:8

availability 34:1835:4 172:15198:20

available 33:2136:1 37:14 39:2246:11 62:1164:11 68:694:18,19 116:18118:19 121:5127:3 148:13174:12 176:11178:6 179:9200:13 206:22237:4 238:5239:12 241:16242:5 243:14,16244:7

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average 68:20

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Avogardo's194:11

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background 12:1346:18 50:11 58:8


Page 8


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bad 67:13 116:7212:9 275:19

balance 102:7234:20

balanced 175:18200:3

ban 251:13

Banerji 5:10202:4,10,13,15203:3,15 204:5210:7,8

Banerji's 203:22

banned 251:16

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bar 140:21 146:13151:4 242:17

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Barton 104:15

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243:10

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basically 23:725:14 103:17126:7 151:12153:7 214:8

basing 214:9

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Becker 57:22

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begin 17:4,6 42:4179:7 196:7,11

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behavior 217:21218:4,7 223:21

224:3 227:11,13230:6

behind 47:9212:12

beings 41:4

Belgium 251:7

belief 228:9

believe 32:2055:5,8 76:20,2292:14 99:17128:10132:14,20 136:5137:3,10,15138:2140:3,11,20142:16,17149:18165:10,13171:13 173:15175:7,9 176:10204:7 206:22243:8 244:21248:8 250:15253:22

believes 171:3

Belladonna 28:16

belong 56:2

Benadryls 223:9

beneficial 51:2115:19

benefit 136:22137:3 139:22206:10 249:20

benefits 18:1434:17 35:4 65:2068:6 89:18 181:3

Benson's 12:15

Bent 2:5

Bernado 172:21

Bernardo 5:6168:11 172:9,18

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Bethesda 266:16

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beyond 72:11127:17 150:9

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biological 15:1333:3 85:20155:16 157:16158:5,12,20160:5,7 161:13164:4 167:17

biologics 160:4164:14 165:9,20

Biometrics 2:9


Page 9


biopharmaceutical 153:7

Biostatistics 2:99:3

birth 234:9 235:11

birthday52:10,16,19152:8259:14,17,18,19

bit 22:19 37:840:14 53:1,584:1,3 86:1687:8 165:8 166:8194:21 225:10246:4,9 259:20

bladder 189:8

Blakey 7:10

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blanks 264:6273:1

bleeding 35:14,16138:21 257:8

blend 235:20

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board-certified

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boarded 12:17,18

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Bockius 102:21

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271:9

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CD4 158:1

CDC 44:7

CDER 4:3 5:189:6,19 10:2117:2,5 262:11

CDH84:3,4,5,11,1485:12 86:1287:22 88:789:5,21 92:3

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6:13 12:10 13:619:2 27:6 43:2271:5,8 76:1682:16,22 83:1,4175:16 188:4190:11 233:8234:1 238:2248:21

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Central 45:5

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CEO 43:8 98:7153:6

Cepeda 153:4

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CERTIFICATE279:1 280:1

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cetera 121:5 148:2


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CH 246:6

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253:5

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Chris 212:22

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Chung 4:1170:10,14,15,1778:8,21 79:1580:22 82:7151:16

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clauses 135:10

clean 81:5

clear 44:14 81:2284:10 91:21 94:4113:21 115:8123:19127:4,10,19162:15 258:12

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197:4 203:20210:2 211:20234:2 246:20247:14253:14,20,21254:1,12

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collaboration.fda.gov/hprapril20157:15,17

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163:11 173:14

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Colleges 43:1145:6

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Commission 45:5113:8 186:10

Commissioner2:6,22 9:22104:14


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commit 136:13

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committee 102:12109:9,10,11,14,17110:3,4,8,11,16111:21 112:1118:17

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Communists252:4

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companies 58:13

69:21,22 70:195:1 119:3129:18 132:8137:14,17174:21 179:21216:6,7 221:21225:13,14231:17240:19,21242:14,22243:18 244:6

company 1:2198:8 108:16133:14 153:7161:10 162:18184:4 201:6203:1225:9,10,11226:3,7,19227:21

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Compendium100:13 101:2

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68:1 92:13,1794:13 99:13,16105:9,13 109:15110:22 113:16114:2 115:10117:9 130:13131:18 133:11136:2 139:3141:12,14142:18 179:16262:11 263:10267:16 272:9

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concern 22:1138:1 65:8 105:6


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150:6 216:17266:20

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Conclusions177:11

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condensing 37:16

condition 20:1722:7,9,10 32:1834:13 46:10 92:297:2,3,4 154:21175:5191:16,19,21192:4 201:14

conditions 22:8,2023:1 45:2048:5,10 50:5,663:17,22 64:1873:4,8 90:18,19105:10 114:13

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139:10 146:11

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consumer 20:825:22 27:731:11,22 32:634:5,12 37:1044:11,17 51:7,9


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61:11 64:965:13,17 68:2169:10 75:1577:17 85:1999:19 172:11173:22 175:22177:2 205:11,12213:19 215:17216:13 217:2,21218:4,6,11 219:8221:2,11,12222:11,14223:21224:1,3,17226:20 227:4,14228:1,16230:6,21 231:12236:3 250:18

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101:22

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112:20 150:21170:3,7 174:6176:6 177:19178:11 181:4,6184:16,21188:22 196:8205:15,19 206:3249:5,14 252:15254:16

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core 46:14 50:21

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CORE-HOM253:11

corporate147:17,22

correct 14:5 42:653:8 223:16259:14 280:9

correctly 37:565:12 69:8 70:14162:6

correspond176:12 201:19

Cosmetic 59:1599:14 170:22


Page 16


cost 226:21 228:18231:11 244:2,3252:13,16

costs 241:9

Cotter 4:21144:15,16,18,19,20 151:7,9,11

cough 73:13,14114:16,17 120:5201:7 222:20

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Council 45:7134:11

counsel 2:11 3:39:5 10:2 98:13102:20 103:1,2104:15 105:12123:16 233:21279:8,12

counsel's 263:19

counter 20:1344:22 47:348:4,9 51:14,2052:1 78:22 80:295:19 96:5,9,11107:9169:19,20,21171:7,18 181:22214:4 220:19222:20 224:15

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countries 13:1084:13 139:9159:15,21

187:19 189:13204:19,21 206:2208:4,6,12,17251:7 252:1254:12

country 90:7139:15 176:1189:5 198:5,7202:20251:10,12,15264:7

couple 52:9151:18 193:7195:2 205:20206:15 212:4,12254:6,7,10

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courses 51:14 88:2

Court 280:5,7

cover 122:14140:8 205:7275:13

covered 122:15124:10 140:14

covering 205:3

coveted 261:17

COX 154:9

CPG 49:11 51:1754:4 92:13,17102:16 107:21111:16114:3,8,22115:2,5,14 116:2128:3 130:18,19

131:19 132:1,9139:20,22 140:4141:3 180:11183:5 199:5207:4 262:12,19267:8,9 269:14270:3 272:2

create 91:9 102:17106:5 123:2126:9 196:11208:15

created 103:8123:12 160:20

creating 106:19125:12 157:20

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curve 49:4

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cut 93:11

CVS 225:20

cyclophosphan153:20

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cystic 12:10 20:571:4 74:15

D


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dad's 234:8

daily 32:8 39:584:8 89:11148:14 241:8250:9

dairy 25:10

Dan 273:9

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database 190:7

200:16 253:14

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date 205:6 280:13

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daughter235:11,16

Dave 10:8

David 5:7,9168:12 172:12178:15,18183:11 202:3,4,8254:6,10

Davis 266:15

day 6:5,10 25:1534:2 104:8123:18 210:14215:6,15 219:16224:4 259:12

days 11:5 20:1821:1 91:6 146:7205:21 206:15212:5 277:4278:9

DC 57:22

dead 275:6

deadline 203:13205:5

deal 112:8 145:12191:21 192:4244:14 247:17249:4 270:8274:15,18275:16

dealing 55:15263:22264:11,12266:10,19

deals 114:12143:21 205:10

dealt 55:21 268:14

debated 142:3

decade 101:3106:10 116:10127:2 273:18

decades 60:2164:11 71:6117:12

December 60:3148:5

decide 117:21118:1 152:19166:14 174:15175:5 199:14

decided 104:20134:17,20 262:3

decimal 193:18

decision 68:11,14

decisions 19:1133:10 79:1391:12 172:12177:12 238:15

decrease 73:6,20154:1

dedication 47:8

deemed 187:4

deep 203:4 204:20260:4

defective 267:16

defects 159:10221:3

defence 159:11

defense 263:20

define 78:15 157:8200:19 267:5

defined 161:1

183:4 221:2269:11

definite 20:9223:14

definition 49:7104:5

degree 43:18 44:145:3 125:16

degrees 30:2 83:15161:1

delisted 217:6220:5

deliver 205:19

delivered 259:2

delivering 177:6

delivery 132:5203:20

demand 228:14

Democratic251:14

demonstrate 42:8122:1 141:19142:4 165:17

demonstrated42:11 153:15154:10 155:1

demonstrating40:19 199:2

dental 169:16

dentists 169:13

department 1:445:9 73:21 81:12235:2 256:7

dependable175:13

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Depends 244:15

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Depot 230:19

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deputy 2:21 9:21

DeRenzo 277:6

derived 53:22

describe 54:13130:22 186:3211:15

described 56:16120:4,13,18121:18 131:20185:22

describes 59:22

describing 163:14

description109:18 156:18

descriptive 114:21124:18

descriptors114:14

DESI 134:19

design 110:20

designated 20:18

designation56:6,17 129:1265:15

designations260:19 265:22

designed 30:16

desire 213:9

desperate 148:14

despite 32:22147:9 176:7177:22

detail 59:22 188:2

detailed 138:6175:18 185:16205:3,7 208:2209:19

details 147:5238:12

detect 155:4164:16,18 168:3245:17

detecting 168:4

detection 156:17160:10 164:19

determinant 78:19

determination105:1 134:3160:3

determine69:14,17 78:1595:11 96:14118:20 127:15162:20 166:1238:17

determined167:14,15

determining 160:9164:5

detoxification49:3

develop 68:3157:19197:3,10,13

developed 127:1161:10 189:9

developing 163:4258:16

development 4:1413:7 18:19 19:271:9 76:16 82:1794:5 145:8160:19 163:2179:2 234:1

DIA 272:22

diagnose 36:845:19

diagnosed 209:22

diagnoses 33:17177:17

diagnosis 34:3120:9 249:1

diagnostic 119:22120:6,7

diagnostics 210:1

dialogue 115:20240:13

diarrhea 28:20235:4

diclofenac 154:4,9

dictionary 31:5

diet 14:2 51:3140:3,16,22142:13239:13,20240:11

dietary 49:2,13,1850:16 53:13,1854:2,5,14 55:761:10 176:20190:4 191:17,20

differ 138:4

difference 26:1866:3 245:1246:6,9 250:8

differences 65:490:8 138:10

176:8 178:1

different 37:1141:1,4 42:1843:1 54:16 55:657:8 69:4 82:1290:22 96:21119:13 130:19134:18 137:11142:12 165:8175:10 177:8187:19 195:16199:20 201:7,10212:2,21 216:15219:9 230:16237:5 242:5245:3,13 263:5266:11,18273:20 274:22278:10

differentiate 87:9

differently 38:2240:18

difficult 41:1542:14 114:18,19121:18 123:1124:2,3 129:5136:21 155:4164:16 167:22249:16

difficulties 146:4

difficulty 42:21152:4,9 164:19195:8

digging 260:3

digital 175:1

diluents 180:7

dilute 25:13 164:2

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dilution 39:14,1540:4,6,10 53:1557:7 155:21156:4 158:16159:1 189:3242:4,11243:17,19 244:4246:5

dilutions 24:1125:13 26:16 27:339:12 57:1290:17,22 95:18157:17 189:2193:18,20245:18 246:3

dim 270:16

diplomat 168:21172:22

direct 117:22150:2 158:7213:6 231:4240:18

direction 23:20279:6

directions63:18,22

directives 260:14

directly 172:10213:5

director2:3,6,13,16,19,21 4:3 5:18 6:119:8,10,13,17,2112:7,10 71:3105:4 108:9,15246:20 248:3262:10,13

Directors 98:14111:17

disadvantage166:8

disagree 128:14

disappear 137:20

disappearance154:19

disappeared 229:2

disappoint 216:1

discard 176:11

disclaimer 142:10267:9

disclose 44:3

disclosure 184:2

discoloration221:3

discouraged251:21

discouraging251:22

discovered 72:9226:7

discovery 235:10

discuss 104:17172:13

discussed 25:22182:19 235:18

discussing 184:7,9

discussion 130:16140:2,16,17141:1,11 143:6195:11,17207:17 222:19239:19 246:4

discussions 115:14130:15 131:17270:17

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diseases 71:22204:14

disorder 81:21

disorders 71:19

dispense 243:16

dispensed 180:19

display 115:7

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dispositive 269:16

disproportionate136:3

disregard 239:7

distinction 53:1457:5,10 258:12

distinguished260:7,10

distinguishing176:19

distorts 49:7

distribute 145:5

distributing148:21

distribution 226:5

distributors 59:2

ditch 248:15

diversity 106:1

division 2:9,13,169:8,17 70:2174:21

divisions 226:4

Docere 50:19,21

doctor 27:13,1932:13 43:18 44:145:2 50:19,2089:3 202:11209:8

doctoral 45:4

doctorate 83:13233:16

doctors 45:17 80:988:3,14 91:1892:15 148:14177:8 233:12241:17254:13,22 278:5

document123:11,18125:13 198:19248:2 267:15,19269:18

documentation83:5 188:21208:2

documented 138:6204:11

documents 149:6182:7

domain 195:5

domestic 131:3

domestically275:14

done 20:4 30:2141:14 42:13103:18 121:19134:19167:10,12197:5,6 200:1210:1 222:9245:5,15,19254:6 255:4256:6 260:6


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door 239:18

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Dossett 5:8 168:12172:16 178:15183:10,11,13194:20 196:13197:19 198:3200:8,15 258:2

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double-blind87:14 120:21159:16

downside 264:12

dozens 159:15

Dr 6:3,109:1,2,7,12,16,2010:4,7 11:1121:14,1922:5,12,2224:1,9,19,2025:3 26:9,2127:2,14,15,1834:7,22 36:18,2237:1,3,1338:5,11,12,13,15,1839:8,15,16,1940:3,5,6,8,16,2241:13,14 42:1043:2,3,5,652:13,15,16,18,1

9 53:4,8,1654:6,755:4,14,16,1856:1,7,1357:9,15 64:1266:12 67:6 68:1969:1270:8,10,15,16,1778:8,11,2179:10,1580:15,2282:4,7,13,1488:19 89:593:14,15,2094:15,17,1995:3,15 96:12,1897:6,7,8,9,10,12,18 98:1,13 106:4108:5,8113:11,14117:16 118:5,14119:15 120:4,18121:13,17122:6,9,19,21123:22 124:8,10125:1,7,8,18126:1,12,13,16,17 127:12,13,14128:1 129:6142:22 143:3144:11,12,14,17,19 151:7,10,16153:5161:14,16,17,18162:16,17163:7,8,9,20164:21165:2,7,12,16,21166:3,7,16 167:1168:6,7,9,15172:9,12,15,19178:15,17183:11 184:8189:20 192:14193:7,15

194:2,17,18,19196:3,13,21197:6,8,9,17,18,19 198:3 199:8200:7,8,15 201:5202:2,13,15203:15,21 204:5210:7,8,18,21,22211:8,13212:9,11,16217:12,13,14220:17 222:17223:8,11 224:20229:1,5,9 230:5231:8 232:15,17233:9 241:21242:1,13243:10,15244:8,18245:9,21246:12,13,16259:5 260:3,12261:13,14,15,16262:7 273:6,9,16276:2,6,8,10,14,20 277:8,9

drafting 141:12

dramatically252:2 254:17

draw 45:21

drawing 194:20

drawn 172:16

dream 133:3

drew 80:19

driven 193:21196:6

driving 119:21120:1

dropped 233:2

drowsiness 237:1

drug 1:3,82:3,10,12,14,16,17 3:3,6 6:7,137:4 9:18 15:1,1218:15 19:1125:19 33:1034:15,22 35:8,1746:22 48:15,2250:2 51:1453:19,20 54:555:7 56:1958:6,759:2,5,8,12,15,18,21,2260:2,13,2061:9,11,1462:15,2163:3,15,2064:6,16 77:285:20 89:1991:12 92:1298:1999:11,14,20101:18104:5,9,13,22106:6 107:7110:15 114:4116:21 120:1123:5 129:12,18134:5,6 135:5136:15 138:17140:5,15 142:15143:7,13,16,19,20 144:9153:18,22 154:1155:12 156:6,14159:9 160:4161:6 163:16170:16,21 171:7180:8,11,17185:3,7,10187:1,6,10216:11 219:19222:13 223:20227:3 228:15


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drug/drug 24:4,6

Druggists 233:18

drugs 35:7,9,10,2036:16 41:2 45:146:15 47:448:2,4,7,8,12,17,18 49:5,8,1450:4,9 51:15,2053:17 55:1159:16 60:9 63:1664:17 72:1173:1,6,9,10,1881:3 82:6 102:18103:4,6,9104:18,21105:7,10,18106:2 113:20114:9 130:20132:19133:12,13,14,16,17,18,20,22134:9,13,16,19135:6,15,21136:7,13,16,21137:7 138:11139:9,17 142:19143:15 144:1,2156:20157:1,7,9,21159:13160:1,15,20,21,22 161:2,11162:20 163:2,15172:6 174:2176:19 177:9,21179:14,22 180:5181:13 183:6226:12 228:10249:16 257:6,7268:12

drug's 110:11

160:9

Drugs 2:17 9:19

dry 114:16

due 7:13 25:9 63:573:15 112:4184:8 228:13240:12 257:12273:14

Dumont 4:411:9,10,11,1321:14 22:5,2224:9 25:326:9,21 27:2,14

during 6:18 62:1189:10 91:6104:19 152:3157:15 172:1262:12

dwell 32:3

dying 263:12

dynamized 161:2

dysfunction 73:1581:18

dyspnea 73:14

Eear 15:19 191:3

earlier 7:18 19:236:2 93:17120:18 121:17182:22 195:13201:13 258:2

earliest 174:11

early 103:16 105:5116:11 226:7278:14

easier 194:5 244:5

easily 59:11 60:12175:2

East 251:14,16

Eastern 251:19252:7

easy 92:19 236:21263:20

eating 23:18

echo 196:13

edema 154:7

Edgar 152:22153:1,3

editions 100:12

editor 43:15 102:4109:5 178:20,21248:6

editorial 43:16

editors 267:13276:17

educate 14:144:21 74:3 80:8176:17 177:7214:18

educated 177:11214:15

educating 51:1679:22

education 4:1413:6 19:2,2244:1,6,19 45:8,949:18 51:1 61:371:8 76:1680:4,14 82:1683:4 174:18234:1 244:20268:17

educational 76:1583:16 144:7174:18 253:1256:20

Edward 5:3

Edwards 104:14

effect 34:15 61:1781:17 87:5118:21 154:8155:1,3,4,8,9156:7 158:4,7159:10164:8,11,13,16167:7 252:13

effective 36:1773:8 75:20 77:2080:17 115:12,21116:12 134:15173:15 226:21228:18 231:11246:7,11 249:19250:2

effectively 34:564:2 123:21173:18 174:20

effectiveness115:10 120:22122:1 183:18194:22 196:15250:1 252:13254:5,11 256:4

effects 25:19 27:1232:12 39:3 73:1077:12 89:2 168:4183:20186:7,8,13188:10 196:7236:17,22239:1,9 250:4254:17,22 257:9258:3 261:3

efficacious 14:13215:9 217:9

efficacy 40:2042:9,11 116:3119:14 120:18121:9 134:6,17


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efficient 116:12

effort 7:5103:15,19105:13 214:19

efforts 103:16106:1 174:6

eggs 41:8

eight 19:9 77:188:1 91:10100:12 247:6

Eighteen 213:22

Eighty-five 52:13

either 10:15 11:117:14 30:8 39:1755:19 56:2,9,14122:15 124:19205:16 236:9245:22

El 28:5

elaborate 22:1924:21 37:8

Elaine 2:11 9:4

electronic 59:2160:7

electronically10:15 11:1

element 100:4273:2

eligibility 109:2

eliminate 69:9215:17

eliminated 217:9

else 23:10 32:1768:3 87:21 89:9165:19224:16,22267:17 272:14

elsewhere 124:14

elucidate 167:6

email 151:19

embarked 106:19

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emergency 73:2081:12 108:14258:17

emeritus 101:13

Emerson 5:12225:4,8

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emphasis 13:22101:12

emphasize 26:336:13 115:4130:8

emphasizes 161:6

employed279:9,12

employee 279:11

empower 136:16

empowering 51:1

encompassing187:1

encounter 16:7

encountered94:22

encourage 150:3200:2 207:17

encouraged147:8,16

encourages198:18

encouraging176:22

endlessly 39:2

endogenous158:11

endorsing 272:18

endowed 253:18

endured 147:19

energy 133:10136:12

enforce 93:3131:2,5 240:16

enforcement21:20 22:344:5,9,15 50:1451:22 56:9,1461:4 131:8207:3,4 262:13

engage 134:2149:9

engaged 221:17

engagement 2:36:12

engaging 51:1

England 43:17246:22 259:9

English 139:2153:8 166:10168:9

enhance 159:2172:14 178:13275:18

enhanced115:11,22153:20 270:3

enjoy 58:16

enjoying 202:19

enjoys 117:12

enormous 277:7

enormously 135:7

enriches 162:10

enrichment162:4,9,13

ensure 62:1 111:4112:12 172:4198:20

ensures 90:1492:18

ensuring 46:1658:15 65:1898:18 99:19112:17 171:20

entire 155:5234:10 250:13

entirely 145:17

entities 274:16275:8

environment64:20 217:4267:7 271:11273:2

EPA 127:5

EPI3 256:5

epidemiologists110:6

episodes 81:7

episodically 131:5

Epstein 153:5161:14 162:17163:21 165:7

equally 36:17194:15 236:4

equipment 268:18


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Ernst 187:15

errors 245:14

especially 17:2242:14 192:6

essential 75:9115:5

essentially 57:7137:4 141:18199:5 251:3254:21 260:12

establish111:3,6,7,10121:3 157:18193:13 195:22

established 14:161:12 92:21111:12 120:19146:14 169:7216:6

establishing 18:1847:22 121:9194:22 199:3

establishment59:21 131:20272:4

establishments62:13

et 121:5 148:2

ethical 51:9110:22

Ethicist 2:21

ethics 216:18

Europe 74:16106:11251:12,19 252:7260:14

European 90:8113:8 204:21

205:6 247:3250:20 251:7260:14

evaluate 62:2124:12

evaluated 219:13

evaluates109:14,17110:11,16

Evaluating 1:8 6:6

evaluation2:3,10,12,15,173:3,6 6:13 59:13101:19,20,22102:2 111:22113:7 119:11206:21

evaluations111:3,20

event 61:21 62:366:14 187:5

events 48:6,2161:8,13 62:5,1463:7 136:20150:18 182:8,9184:14,17185:17,18,19187:18,20,22189:6 192:8

everybody 98:2202:5 207:14208:22 255:3257:8,16 270:7

everyday 19:6

everyone 6:333:16 67:10 98:4137:13192:16,17276:22 277:12

everything 10:21

130:3 163:12165:19 167:12210:15 211:22212:7 232:10

evidence 8:1117:20 35:2180:19 110:9112:5118:7,11,13,14179:7 189:15196:11 203:8204:10 206:21249:10 254:2261:3

evident 170:18

exact 230:13

exactly 125:18141:4 149:15230:21 259:1

exam 47:7

examination 47:7248:20

examine 177:21187:12

examined186:5,10,15190:7

examining 110:12134:8,16 188:1

example 23:242:15 49:1253:19 57:2 73:1181:17 91:1495:21 114:16116:16 148:16155:14 158:15189:7 197:10201:6

examples 38:8,1673:22 88:5

225:18

Excellence 247:14

excellent 17:197:10 133:14184:9 240:4

except 208:6,12257:4

exception 268:13

exceptionally14:13,20 170:4

excitement 233:2

excluded 135:16

excluding 48:16

exclusively 94:15

exempt 149:7,15

exempted 143:15

exercise 46:8 51:3239:21 241:4

exhaust 135:11

exhibit 154:5

exist 44:10 48:14147:6

existed 267:22

existence 181:17

existing 47:1849:21 50:1460:22 61:22 63:264:5 99:6 113:15

exists 22:2 69:1876:12 268:13

expanding 150:17275:8

expect 47:14 91:19112:8 135:20

expectation 93:21150:9 228:17

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experienced 68:4263:4 264:8

experiences 150:1173:19,22184:16

experimental110:13 153:12157:16

experimentally167:16

experiments 118:9159:14

expert 36:16 56:13110:4 207:16216:20 247:20258:19

expertise 24:10172:3 178:6181:8 202:13264:2 272:5,6

experts 102:10109:12 116:18200:4

explain 16:16 20:726:4 142:10147:5 167:11

explained 16:1817:21 189:20

explaining 16:1099:8

explains 79:17

explanation 156:9

explicit 114:2

explosive 132:18133:1

exposes 49:22

exposure 221:8

exposures 189:22

expounded 29:17

express 160:10277:10,11

expression 159:2

exquisitely 166:20

extant 169:8

extended 48:12149:21

extends 93:8

extensions 206:6

extensive 31:1633:1

extent 31:17 66:6193:21 263:7267:14 270:7271:18 273:4

external 90:19126:8

extra 251:22

extremely 88:12136:7 170:1226:18

extremes 272:16

eye 224:13 232:13

Fface 8:21 265:6

272:1

Faced 134:8

facilities 59:18146:6

facility 202:17

fact 17:1 26:1132:4 77:1984:6,19,20 86:1387:4 89:1 90:796:20 105:6125:13 130:20131:1 133:4140:13141:15,16143:14 148:7160:18 209:14240:12 260:13272:14

factor 155:21156:2 167:20

factors 29:14

facts 138:17143:7,13,16,19,20

factual 175:11

faculty 233:22247:10

fail 205:19 215:19217:1

failure 257:11

fair 125:16 136:1200:3 222:19225:22

fairly 12:11 82:3

139:2 218:18

faithfully 33:1

fall 101:17 137:10182:16

familiar 12:2079:8 173:12174:3 195:21198:4 199:13200:18 234:21

familiarize 106:6

families 75:8236:7

family 35:11 80:888:20 89:14108:12 169:1191:12 238:1255:6 256:21

fascinated 29:8

fast 202:6

fatalities 187:21

favor 255:16

favorable 236:4250:20,21

favorably 227:18228:16

FDA 4:3 5:186:10,21 7:3 15:718:13 26:2031:12,15,22 33:834:8 35:20 37:2038:21 40:1847:19 49:1151:21 52:3 58:359:10,1960:12,20 61:1,1562:1,11,15,1963:8 64:1,767:7,9,11,1768:4 69:1,9,1389:17 92:21 93:3


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FDA's 7:4 11:559:4,9,19 60:1661:6 63:2,9 66:899:22 121:8129:16 132:17139:10 170:14184:5 205:8207:10 270:3,12

fear 163:11

feasible 255:5

feature 14:22

features 161:13

February 190:12

federal 8:4 59:1575:14 99:14103:8 106:14131:12 134:22135:13 137:5198:17 250:17

feedback 8:3201:4 250:12

feel 10:11 15:225:15,18 27:932:22 33:2 96:15122:3 195:3203:16 207:5,8208:5 236:9237:2 238:16239:3 240:16241:2 243:2

feeling 195:5,9

feelings 143:10

Feinberg 4:1170:11 71:1

fellow 247:9,10

felt 191:20

fever 28:20235:13,20,21

fevers 28:17

fewer 254:21

fibrosis 12:10 20:571:4 74:15

field 114:11145:12 150:19172:3 184:10196:17,20 248:5

fielding 74:480:11

figure 25:9 128:11129:4 224:3

233:3 263:5266:5,13 271:6,7272:10

figured 266:18

figures 83:22190:22

file 132:7

files 62:11

filing 76:21

fill 169:22 263:17264:5 272:22

filming 152:19

filter 232:9

final 94:7 104:13105:2 111:18133:18 144:14268:14 276:2

finally 50:8 52:383:17 135:9139:21 142:7189:6 257:20

financial 11:1644:2 184:2202:22

financially 279:13

Finder 238:4

finding 234:17253:2 256:15257:15

findings 175:6

finds 188:2

fine 195:6 210:19

fingerprints267:10

finished 62:7149:14 262:12

firm 57:22 153:3

firms 59:1660:1,4,6,11 62:9

first 6:10 11:815:11 31:2241:2,17,22 45:347:11 55:5,1659:9 72:7,2082:19 85:5 87:490:12 103:7109:4,11 110:1113:1 122:22123:2,10126:18,21134:5,9 137:11154:16 158:3170:18 184:5203:22 214:14215:1 218:17230:10,11231:10 233:13234:11,21250:18 262:20263:14 266:6267:8

Fisher 5:15246:13,15,16259:5,6 260:12261:14,15276:8,10

fit 26:7 121:22266:2

five 12:9 21:1742:15,18 44:752:21 93:18112:14 118:3143:1 190:13195:14,15199:20 208:3273:7

fix 264:5

flag 56:10

flawless 226:16


Page 26


flippant 147:17

flu 182:14

fluidly 123:3

flying 86:2 229:3,4

focus 234:17

focused 58:9108:19 112:16

focuses 45:10

folks 6:4 10:11151:18,22 262:2263:18 265:5,19266:13,21 268:8

follow-up 54:1055:2 56:8 62:1765:22 68:1996:12 196:21200:12 220:18222:17

food 1:3,8 6:653:19 54:1,655:7 56:19 59:1599:14 103:9129:12 136:15140:19 142:14170:21 232:2

foods 27:839:11,20 95:20

fool 33:15

force 225:22

foregoing 279:3

foregoing/attached 280:8

forensics 233:3

foresee 8:14

forget 263:12

Forgive 119:9

forgotten 85:3

form 27:6 139:16

154:5 157:17164:3 239:4258:20

formal 13:3 60:1867:7 235:8

format 59:21 60:7

former 49:15170:20

formerly 70:20

forms 153:22242:6

formula 25:10

Formulary 103:11104:7,11

formulation 160:9243:11

forth 33:19 39:755:20 66:15,2078:14 105:9167:6 218:3260:9

fortunately 78:1

Fortune 108:15

forum 61:1888:7,11

forward 99:7117:14 172:2193:4 238:9248:3

forwarded 109:6

foundation 125:22247:5 253:16,18

founded 36:2158:18 225:11

founder 29:16

founding 43:1583:9 168:21225:8

Fourth 63:13

framework 1:96:7 7:4 8:7 44:951:17 58:5 63:364:6 100:5102:17 106:5113:16 115:22172:14 179:9,12200:19 205:5208:16 222:15260:17 278:11

France 83:14250:21 252:20255:4,5 256:6259:11

France's 83:15

frankly 31:1038:21 128:16144:5

fraud 264:4,7267:2 274:14

free 33:5 174:22186:12 204:1215:16

freedom 33:6177:14

French 85:1793:10 251:3,4,5255:7

frequency 184:16

frequent 237:6

frequently 187:7192:11 237:9,21249:20

friends 7:14191:12

front 168:1 214:5

fruits 105:22

Fueled 228:8

fulfill 231:13

full 45:20 67:1,18106:19 248:20253:22 260:22273:12

full-time 70:18

fully 16:17 134:14248:17 249:18262:5 268:6269:8 270:13

fun 232:22

function 159:7195:4

functioning 100:4179:12 195:6

functions 113:17

fund 177:1 199:9

fundamental176:8 178:1

fundamentals275:12

funding 176:21196:18,22198:18 200:2

future 36:6 115:1177:8,9

Ggain 104:4

gained 14:10

Gallinger 103:14

game 275:1

gamed 54:16

gamma158:17,18,19159:2,3,6,8

gap 250:1 265:7266:4


Page 27


gardener 93:16

Gary 4:16 5:1397:20 98:12102:18,20 106:4233:6,8,9 241:21

gastric 257:8

gastrointestinal35:14,16

gateway 30:9

gather 60:19

GDR 251:13

general 28:1941:15 60:20 64:498:13 103:1104:15 119:8123:1 148:1166:9 173:7183:15 189:14213:6 249:21263:19

generalize 79:2

generalized 78:22147:18

generally 65:16,21118:17 120:19125:16 127:20129:1 138:15141:20 147:19182:5 189:4193:17 250:20252:10

General's 248:3

generation 101:20127:8 169:4

generations 236:8

generics 219:18,19

genesis 161:4

gentlemen 117:16129:6

genuine 176:6

German 145:19146:16 147:13148:3,8 188:4198:8 200:16,18251:14

Germany145:6,15 146:6186:16,19250:22251:6,14,17252:20 253:18275:17

Germanys 251:18

gets 175:21 222:9

getting 32:1140:12 67:18 84:186:19 88:15148:13 166:11240:10,11249:15 254:9

Gibbons 5:12225:4,5,6,7229:3,7 230:4,9231:14 232:16

gifted 173:13

Gilman 153:4

given 15:16,1817:15 69:20 76:3111:11 120:11122:1 136:8182:12 189:11195:12,19 205:9

gives 90:21 252:15

giving 172:20203:9 233:10235:17

glass 245:13

glaucoma 237:8

glaze 20:22

global 42:3 147:12203:8 204:17257:18273:21,22 274:3

globally 145:18148:22 149:1

GMP 109:15112:18 145:19146:5,22148:8,19 183:1

GMPs 55:20101:20

goal 14:4 73:589:20 90:1225:14 277:22278:8

God's 272:15

gold 121:9

golden 215:11

gone 56:3 107:17220:14 254:8263:12 269:20

goods 58:17

Google 253:12

gosh 95:21

gotten 152:11

govern 101:14

governing 100:5103:3

government 178:2186:10

governmental275:8

gradually 157:19

graduated 83:20

graduates 45:18

47:14

graduation 88:4

gram 119:2

grand 17:15 20:3

grandfather135:10 203:22

grant 200:3

Granted 245:16

grapple 263:6

grappling 276:13

grateful 98:9

great 1:14 16:1833:13 112:8117:17,18 174:2186:6 191:21192:4 198:3207:13 212:10220:2 244:14247:17 249:4276:14

greater 106:5113:6

green 162:8245:10

grey 182:18

grounds 270:11

group 5:12 6:1211:22 18:9 98:15109:10 120:14123:13 130:14181:7 202:10203:1,4 223:2225:5 257:4,7262:3

groups 109:8115:19 176:1,3185:18,19 237:5

grow 217:5 228:11


Page 28


growing 30:18131:14 251:1263:2

grown 226:12

growth 132:18133:1 263:9

Guatemala 28:5

guess 120:3127:19 146:8261:19 265:18

guessing 65:6

guidance 46:1747:19 59:19112:18,19 113:6114:2 143:15149:6 162:9

guide 37:19 47:2059:6 68:2 92:1399:13,16105:9,14 113:17114:2 115:11117:9 130:13131:18 133:12136:2 141:12,15142:18 179:16181:12 238:1274:7

guided 15:7

guidelines 44:1548:19 90:15 93:5107:13,14108:2,4 112:17117:3 125:21170:5 171:9,10179:3,4,5 181:21194:9 196:6,9197:10,13202:18 208:6211:4,7

gum 138:22

guy 266:14

guys 166:14255:12

HH1N1 182:14

habit 73:14

Hahnemanium244:22

Hahnemann29:16 30:21

hair 273:12

half 41:18 187:3257:5

half-time 102:4

hallmark 157:5162:21

haloperidol153:19

halt 30:3

hammer 130:3

Hampshire 1:16

hand 55:7 113:11193:4

handled 106:22

handout 16:12

hands 36:16 213:2

handy 276:18

happened 262:18264:19

happens 94:5199:12 220:6

happy 52:10,16,19133:7 136:17152:7 210:14

hard 128:11 129:4221:9 222:12

264:15 274:17

harm 33:7 85:1490:2 171:6,19205:14 206:7236:10241:14,19

harmful 35:2250:1

harmonized112:18

Harvard 12:15183:16 190:18

hash 7:19,22 8:2

hate 83:20 254:8

haven't 133:8146:4 198:11,14260:21 264:9275:13

having 26:2 32:1236:8 53:17 92:9203:7 204:9,13207:16209:20,21 237:4239:11 241:15267:10 271:22274:15

HCG 182:13

HCP 88:5 90:10

HCPs 86:17 92:7

head 23:2 191:4273:12

headache 28:2033:18 76:7,8166:11

headaches 235:5

heading 198:22

headlines 147:18

healing 28:16

health 1:4 4:8 7:634:14 42:2043:5,9 44:6,8,1949:18 51:10,1261:10 64:2 89:1099:22 136:3,22139:11 147:12175:17 179:3183:17 186:9190:11,19191:15 192:3215:8 216:9225:13 235:1239:15,18 241:7247:14,18 249:8250:14 257:19264:4,6 267:2271:12 274:14

healthcare 5:1215:1219:10,15,1720:15 32:1 33:963:8 64:3 75:1577:1 79:12 80:985:19 86:2291:11,15 92:19169:21 173:16175:22177:16,19203:19 204:2205:11,15206:10 215:3225:4,8 238:14240:1 241:3,9247:16 248:5250:19 252:10257:21 262:22263:3

healthier 241:18252:19

health-related58:15 191:19,21

healthy 41:4 93:9


Page 29


156:14 157:13159:18

hear 32:8 43:3117:18 213:13225:3 229:8239:8 278:10

heard 75:7 76:1991:6 93:17 96:697:1 105:5130:22 139:10142:8 152:5,7195:13 205:20206:14 208:8,21230:1 233:12240:14 262:17264:14 278:2,3,7

hearing 6:8,15 7:28:9,10 23:930:19 91:6116:13 130:2131:13132:13,17135:14 136:6137:6 166:10207:13 238:3268:3

hearings 146:14

heart 216:21251:12

heated 270:17

he'd 210:13272:10

held 8:9 57:16217:7

Hello 9:1 200:7233:9

help 8:7 10:932:12,16,2051:18 72:976:6,8 89:9 96:5171:3 172:4

174:18175:11,14176:17 177:1185:9 198:19,20205:14,18 206:7225:11 238:7239:12,21240:11241:17,18275:17

helped 75:8 113:2191:15,20 192:3

helpful 14:2075:12 80:5107:18 117:2132:15 184:19185:12 192:12237:5

helping 7:11 234:6

helps 61:22

Henry 181:14

hepatic 49:3

Hepatitis 42:16

HEPs 86:2287:9,21

herb 54:2

herbal 4:10 15:416:8 25:17 57:1958:2,9,11,14,20,21 77:9,11176:20 180:15241:4 258:7,13

herbals 77:15 79:1

Herbert 12:15

herbs 19:21 26:1177:12 80:13164:15 190:4

herding 261:21263:7

hereby 279:3280:4

here's 72:14,1793:9

hereto 279:13

he's 89:6 212:22254:8

hesitated 235:17

heterogeneity186:6

Hi 10:1 70:1778:11

hiatus 252:2

hidden 252:17

high 99:9 101:10122:18 125:5150:8 155:20157:17,18159:12 171:15186:12193:9,11,14194:15228:13,19234:22 237:7

higher 25:1226:16 40:1 45:5193:20 194:15239:5 253:1256:19

highlight 49:1455:1 122:13

highly 170:11187:13

high-quality 92:18

hinder 216:12

hindered 176:13

Hippocratic241:11

historical 111:14

117:17

historically 62:19160:21 176:13

history 33:2246:22 100:3102:16 103:5137:19 153:9216:8 235:7248:20 276:15

hits 119:7

HMPs 260:15

hog 122:7

hold 43:22

Holding 5:4 153:1

Holdings 153:5

holds 222:4

holistic 29:5 43:12168:22 173:2234:14 243:5262:22

home 16:11,15175:8 213:12222:9 230:19,20

homeopath 38:2042:16

homeopathic 1:74:18 6:5 7:5,915:3,13 16:2118:4,15,2219:6,12 22:1723:12,21 24:3,625:12 26:1327:1028:1,10,17,1829:5,11 31:7,1632:2,5 33:1134:19 35:2,18,2136:2,1437:7,11,15,2138:2,11 39:3,10


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41:12 42:3,12,1944:11,16 45:146:15,20,2247:3,10,2148:1,2,4,7,12,15,18,20,2249:7,9,14,1750:4,9,1551:6,14,2052:2,7 53:11,1754:14 55:9,10,1156:5,6,1757:4,6,10,11,12,13 58:6,759:2,5,8,1260:13 61:8,1462:15,2163:3,15,2064:6,16,21 65:566:3,5 68:13,2069:3,11,21 70:271:10 72:1673:2,7 74:15,2175:10,16,1876:12,13,1577:3,4,10,14,16,19 78:2 79:1380:1781:4,6,16,2282:683:7,10,12,14,16,19 84:12 85:2188:4 89:6,1990:2,691:1,13,1792:8,12,20,2293:6 94:295:1,9,11,1496:17 97:2198:5,8,17,19,2299:3,5,10,11,20100:6,8,15,19101:11102:18,22103:3,6,22

104:16,17,21105:6,10,17106:8107:8,10,14108:2,3109:12,16110:7,12,15,17111:8,11,13112:20113:6,10,18,20114:5115:6,9,15,17116:8 117:3120:8,15 121:12122:5,12 125:21127:21128:8,18,20129:18,20,21130:20 131:4132:19133:3,12,14,22135:21,22136:7,13,20137:6,15,19138:11139:5,9,17140:2,6,9,18,21141:8,10,17,20142:5,9,19143:8,15 144:1,9145:15 147:19148:20153:10,22 155:5156:6,10,12,20,22 157:6 162:22163:1,4,15 164:6166:19169:4,11,15,18,20170:8,13,16,20,22 171:6,16,18172:4,6,15,17174:1,3,14175:10176:5,7,18,19

177:2,14,20,22178:3,7,11179:14,17,19,20,22180:2,5,7,9,10,11,15,17181:3,6,12182:6,12,20183:6,22184:3,7,14,19185:4,8,13,18186:4,5,17,18187:4188:7,14,19189:1,5,9,10,15190:1,2,5,20191:7 192:6,8,10197:1,22198:4,19,21199:7 201:3203:19 205:4,18206:4,10207:11,19209:10,12211:1,5 214:7215:13216:5,11,16,20217:20 218:22219:10,15,21220:21 221:6,16222:5223:2,7,11,14226:10,12227:16228:2,10,15229:22 230:7233:11235:1,3,19236:1,4,18,21237:4,22 238:16239:11240:3,8,20241:15 242:2243:12,13 244:3255:13

258:3,6,13260:7,15 261:7,9263:16,20264:1,3265:8,14,22266:7,16 268:11270:5 271:2272:6,14,19278:12

homeopathically119:18

homeopathics77:20 79:1140:16 148:2177:9

homeopaths 30:1173:10,19205:17

homeopathy 4:145:813:3,5,7,18,2014:11,17,2216:2,8,11 17:1619:1,3,19 20:7,821:6 22:21 23:125:5 26:5,1527:4,20,2128:4,7,9,1329:2,9,16,20,2230:6,9,11,1832:12,16,20 33:436:11 40:2141:1643:17,21,22 44:746:6,13 47:5,1352:5 71:9,13,1772:14,15,20,2174:1,5,7,13,1875:2,7,17,2176:1,5,17,1877:8 79:1780:3,10,12 82:1783:5,18


Page 31


84:5,7,10,2285:8,986:5,8,13,2087:4,11,12,16,2088:10,16,2189:21 100:11108:18 113:9114:12 121:16127:18 131:13138:13 150:20153:13 154:18155:11 157:5,13162:21 164:2168:13,20 169:6172:12173:6,9,15,18174:5,19,22175:12,19,22177:4,7,12 181:2182:9 183:19186:11187:16,19189:13 190:9,15191:2,6,17192:1,2 193:8,16197:2,14199:13,16 200:4203:5,8204:14,17208:16 234:2,21235:7,8,10 236:9237:15238:2,3,17239:16240:17,21 241:4247:11,12248:7,10,16,19249:9,12,18251:1,4,10,13,16,20252:11,14,18,21253:14,20,21254:15255:10,12,17256:17,18 257:4

263:10 265:2276:13 278:5

homeopotentiation 157:7

Homeotherapeutics 100:14 101:2173:1

homework 222:3

Honduras 28:5251:11

honest 219:2

honor 246:17276:11

honorary 83:11

hook 166:18

Hoover 4:17 97:2198:13108:5,7,8,9113:14 119:15121:13,17 122:6124:10 125:1

hope 28:2 30:952:14 70:13 98:2116:12 132:9,12168:4 171:22200:8 211:9258:11

hopefully 20:142:4 123:18175:16 220:16259:20

hoping 30:13149:19

Hopkins 36:21

horizon 135:21

hospital 4:12 5:1512:4 18:5,1022:15 23:5 35:1336:21

70:13,19,21173:5 183:15246:14,21 247:2250:7,11

hospitals 20:1247:5,7 250:13

hour 41:18 151:13

hours 45:14102:13 108:17184:2 235:22254:7

housekeeping6:16

Houston 27:19

HP 262:2 269:7

HPCUS 15:818:1798:14,15,1799:8,21 100:3,18101:9,14102:5,7,16 103:2105:12 107:7,20108:9,19 109:1111:17 112:5113:15 114:22115:4116:6,14,16,20117:6 175:14183:5 194:10

HPUS 48:19 49:1150:10 51:18 54:456:390:13,15,16,2091:392:8,9,17,2293:5 95:6 96:798:13 100:11101:4,7 102:16103:14104:3,7,10 106:6109:3 112:14114:1 116:22

117:10127:1,19,22128:1 150:15183:5 211:6245:5 265:9,20

HRs 261:7

huge 31:5 249:7

human 1:4 15:1233:18,22 41:485:20 110:13112:19 260:16

humans 110:2111:7

hundred 102:13204:9 216:7

hundreds 71:18159:14

Hutt 104:15

hybrid 55:5

hyper 237:1

hyperergic 155:11156:3,8 167:4201:14

hyperlinked 123:2

hypersensitivity156:21

hyphen-H-O-M253:12

hypnosis 12:16,1714:9

Iibuprofen

235:13,14,16,22236:1

ICH 107:13109:15 112:18

I'd 27:9,16 74:1775:13 77:13


Page 32


82:20 85:3 100:2106:6 108:5161:21 165:6171:16 202:3,21203:9 220:17,20237:19 242:2,6244:8 260:5

idea 6:20 31:841:5 71:21127:20

ideally143:8,13,14

identification109:18 111:19

identified 18:1389:17 95:5 115:6172:6

identify 50:892:19 124:6

identifying 61:2219:9,14

identity 111:3120:12

ignoring 50:5

I'll 7:1 22:1432:18 69:6108:11 113:11117:21 118:3122:10 124:2152:19 163:12166:14 179:1183:8,21 184:5186:13 189:20191:1 192:22193:1,5,15 196:3202:6 209:15229:12 230:9252:12 260:1274:13

Illinois 74:10

illness 73:17

illnesses 20:10,1122:18 29:4

I'm 6:10,119:2,4,8,13,16,17,20 10:1 11:12,1912:11,17,1822:22 24:20,2225:3 27:18,2028:6,8 32:3,1133:18 42:11 43:853:4 54:10 56:1357:21 65:6,766:15 69:870:4,17,18,21,2271:6 78:14,1880:22 82:2283:3,6,9,17 84:185:16 87:8 88:2093:21 95:2298:4,6,9,12108:9,11 122:8125:18 126:3130:8 136:17138:19 145:3148:13149:17,19151:2,20 161:19164:21166:10,11,17167:2 168:19,21169:3,5 173:3178:18,21179:11 189:17194:4,20 195:20198:3 199:3200:17,18,21202:8,11,18208:6 209:10210:4,6211:13,14 214:9216:20,22217:16,20 219:1222:22 223:3

225:7 229:3,15230:5 233:15,16234:4 239:12240:18 242:20244:12,16245:14 246:20247:9,10,11,12,18 248:6,12,13,21249:7 254:9258:18 259:1262:8,16 268:7269:20 270:19271:7,16272:18,21 274:4276:16

imagine 148:10274:2

immediate 131:19

immediately 147:8

Immo 10:9

immune 160:8

Immunology183:17

impact 131:19274:6

impacted 264:20

implementation107:19 117:5123:17 137:2264:12

implemented116:2 127:11145:21

implementing264:15

implied 161:22

implies 143:6

import 59:17146:1

importance 47:9149:18 170:17184:11 216:9227:22 228:9

important 14:2115:8 51:11 54:878:3 85:2 100:4142:16 147:15164:18 169:22171:20 173:16177:5 203:11215:5 226:14227:1,12 228:3242:3 262:19

importantly 89:399:15 123:21156:20 178:22228:12,17

imported 131:6,9

impossible 37:18156:13 210:11

Impractical121:14

impress 248:14

impressed 79:18

improper 240:17

improve 113:2

improved 14:2159:5 174:17

improvement87:17,20 176:15207:9 250:8254:14 255:20

improvements102:1 255:16269:20,21

improving 58:12150:17

inaccurate 178:4


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inactive 49:1553:3,7 54:17

inadequate 63:22

inappropriately63:21

inaudible 12:1639:18 97:11156:19 157:2158:5 164:17,18229:17

Inc 4:22 144:15

incidence 136:19149:1 185:17186:6

incident 145:17148:3

incidents 146:4147:10

include 14:6 18:2146:3 51:13 59:166:9 70:6 103:14107:21 138:20142:20 145:7170:1 182:13200:17 238:12

included 104:2,6187:21 208:7,10214:7

includes 12:1458:10

including 7:645:14 46:1,2147:17 52:5 58:1762:21 63:7,1167:3,11 74:8,1491:14 101:20102:13 107:17159:16 160:10177:9,22 181:9198:17,22

223:19 256:10

inclusion 48:1,8121:19

incomplete 178:4

inconsistent 40:2149:4 121:11,14

inconvenience224:9

inconveniences214:22

incorporate 88:21

incorporated100:17

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Medline 248:9

MedWatch 61:17

meet 45:21 51:2199:18 101:15107:13 171:14215:17,19 216:1217:2

meeting 6:2211:3,5,6 76:20104:19 117:6131:16 166:10216:21 232:20272:12 276:21277:8 278:15,16

meetings 102:12112:11 203:2278:13

melange 36:7

member 28:883:7,10,11 98:14181:1233:18,21,22247:12,18

members 2:4 8:1743:7 59:1 67:489:14 101:14102:8,11 144:5169:12 176:2178:8,12 181:2,5185:4 202:7212:18 213:3,5277:2,21

Memorial 70:20

meningitis 258:16

mental 29:13

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mention 8:8 80:682:22 168:17193:7 214:14

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mentioned 14:719:1 21:20,2222:3 23:13 24:225:2 32:3 36:2237:13 38:6 41:1453:1,5 54:20,2255:20 78:1281:15 92:2 93:21121:2 128:6134:14 205:8211:8 218:11237:18 244:9251:11 258:2

merchandise224:7,16

merchandising214:4

merchants 232:3

merciless 36:4

Merizalde 5:6168:11172:10,18,19,21194:2 199:8201:5

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methodologies167:14

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methods 87:1189:4 101:20102:1 157:10163:21 242:10245:11,13251:22

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metropolises204:22

Meyer 212:20

Meyer's 213:1

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Michelle 5:8168:12 172:16181:9183:8,10,13258:1,2

Michels 5:16261:18,19 262:1273:6,13 274:8276:5,7,11,15,19

microphone 11:12

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mineral 57:10

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Ministry 261:5

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minuscule 24:13

minute 151:18,21

minutes 7:1 21:1752:10,21 93:18118:3 143:1152:10 167:10212:12 273:7

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misinforming240:22

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misleading 54:1777:16

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Mittman's 152:7259:16

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mixed 85:1

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mixtures 29:1030:7,12 31:1736:2 38:11270:10

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Moms 29:6

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Montpellier 83:13

Morgan 102:20

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morning 6:39:1,4,7,12,1610:4 23:15 57:2070:18 82:1998:2,4,11 102:19108:8 129:10253:19

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Mothers 236:18

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move 30:10 123:3


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multiple 29:1539:12 82:10112:10 154:17161:1 184:21198:1 200:12

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nation 231:22

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Net 274:20

Netherlands 251:6

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neurology 173:4

nevertheless 63:6265:4 270:18

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newsletter 74:10

NGO 100:18

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NGOs 177:4

NHS 247:5

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Nielsen 230:17231:7

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NIH 175:17190:12 200:3

NIHCE 247:13

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Northwestern4:5,11 11:1070:11 71:1151:17

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November 214:11

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NSAID 185:7

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nutrition 12:923:3,8 46:4 72:1225:13

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Oath 241:12

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objectives 111:2

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outline 109:2125:5

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pairing 23:11

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pamphlets 80:3

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pharmacist 194:4202:12233:13,15 234:8242:6 245:11

pharmacists 18:2219:5 44:13 51:16102:9 116:8129:20 142:9201:3233:19,20,21278:5

Pharmacoepidemiology 256:7

Pharmacognosy3:5

pharmacokinetic160:15

pharmacokinetics

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pharmacologic200:15

pharmacological30:5 153:21157:15 160:6162:19 163:21

pharmacology 3:546:3 157:11237:22

Pharmacopeia44:16 47:21

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pharmacy 51:1364:20 109:12123:1,16 214:5234:6,9,22235:6,15 236:14237:6 239:17240:7 241:16243:3,22 246:1266:16

Phase 186:8

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phrase 54:15130:12

physical 29:14154:21 161:13167:18 248:20

physically 160:17210:11 234:18

physician 12:2223:21 33:1446:18 70:18 84:688:20 103:22108:12,15138:12 169:4,14170:20 215:2238:10 248:12276:9

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physics 167:21

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poison 27:5 63:8182:7 188:4,5189:19

Poland 252:5,6

policies 2:13 44:550:14 103:3171:4 207:5209:5 271:13

policy2:6,11,14,199:6,9,14 27:159:6 68:1 92:1399:13,16 102:10105:9,13 113:16114:2 115:11117:9 130:5,13

131:18 133:11136:2 141:12,14142:18 145:8179:16 212:19213:6 278:6

polyclonal 157:19

polypharmacy249:7

poor 258:11

popular 89:6170:14

population 121:21162:11 189:14190:14 215:7,11251:5

portfolio 227:9,16229:10

Portland 178:19

Posadzki 187:13

pose 209:15

posed 75:13

position 66:7 70:4131:1 139:3214:3 216:14220:18

positive 88:13,16248:4 253:3,4

possess 154:15

possesses 154:14

possibilities176:15 258:22

possibility 84:796:8 207:15

possible 50:253:10 63:1068:20 122:4,6,11157:8 273:5

possibly 21:22

post 146:18151:19 274:15

posted 11:4 34:767:12 152:14

post-partum89:10

potencies 40:1107:8 123:10180:5 186:12189:3 193:17,19194:6,15

potency 107:22193:9,11,14194:1,12 240:9

potent 39:18

potential 34:1635:1,2 62:1669:10 110:12119:12,13,15157:9 158:15178:9 227:7248:5

potentially 50:153:13 77:12

potentiate 164:14

potentiated153:15 154:5,11155:2,8 156:4,14157:1,4,18,21158:4,8,16159:1,13,20161:2

potentiation167:7,17

power 247:16,17

Powerful 144:19

practical 164:20

practicality121:15

practice 11:2213:21 14:3,12,1916:2 19:5 26:427:19 30:246:13,14,21 52:662:7 72:17,2275:10 77:2179:15 80:8,2181:6 82:7,1184:8 87:10,1788:6,21 89:7,21106:2 173:7180:21 186:18204:4 236:12248:17 249:13272:14

practiced 43:20248:16

practices 68:1488:19 94:14106:3 108:4127:18 209:3256:9 268:12270:21

practicing11:14,20,22 74:287:16 90:4

practitioner 13:2234:14 191:10192:1,3 203:21

practitioners17:13 18:119:5,15,18 45:1847:10 80:9,1084:19 86:10 87:1169:14 174:19182:1,3 197:1205:16 206:4230:2 236:8243:13 246:8

pragmatic 84:11

pre 134:8


Page 50


preamble 105:2

precise 114:3,15

precision 114:18

preclinical 45:11

predecessor276:12

predictable245:14

prednisone 153:19

pre-existing106:16 186:1

prefer 16:3 29:9

pregnancy 89:10

premarket 27:1139:16

premature 18:5

premiere 83:15

premise 41:8

pre-order 6:20

preparation153:16 154:11155:2 158:8244:10

preparations155:8

prepared 48:1957:11,13 90:15153:18 160:5

preparing 104:12277:16

prescribe 73:1180:20 201:10205:18 209:6241:12

prescribed 18:432:10 33:2 189:4191:11 207:12

prescriber 36:16

prescribing 28:2129:1,19 42:22184:19

prescription 9:1847:3 48:17 49:551:5 52:1 60:961:11 63:1664:17 84:2195:9,12,14 96:17107:9 114:10130:21 133:16134:9 180:18,19181:21200:11,20 239:4

prescriptions204:12 206:13255:20

presence 83:2204:17,18226:10

present 16:1531:13 54:17 59:463:5 76:20 98:10108:11 111:5130:12 135:11136:9 147:4172:16,20 205:2238:3 276:22

presentation22:13 36:19 37:438:6 39:9 79:1180:15 95:4 118:6124:1 145:1153:8 156:3161:19 163:10166:17 167:11168:18 179:1205:9 224:18231:9 242:2260:5 277:17

presentations

15:16,17 74:13192:15

presented 136:6200:10 229:10

presenters 121:8150:14 207:7,15277:13

presenting 91:797:20 277:18

preserved 198:2

preserving 262:4

president 43:883:4 98:5 168:19169:5 170:21172:2 202:9221:13,14225:1,7 233:17253:17

presiding 2:2 4:36:2,14 8:16

press 74:12147:11,16197:16 212:20213:3,7

pressure 42:1237:7

presumably191:11

pretty 40:18 76:983:22 146:3,13253:2

prevailing 176:12

prevalence 107:1

prevent 66:1769:1 73:3 147:2213:10 275:17

prevention 73:19

previous 54:10,2155:19 57:2 143:4

150:14 216:14262:6

previously 12:216:3

price 218:2,12274:21

priced 218:14,16

prices 219:17

primarily 14:116:6 22:17 58:9

primary 14:418:16 45:1789:20 111:2119:11 231:1

principle 115:7207:5

principles 17:1924:16 46:2150:21 57:12

printed 175:1

printing 147:17

prior 71:3 110:18124:17,19130:18

priority 100:22196:18

pristine 95:2

private 11:21

privilege 90:4

privileged 98:7115:13

proactive 149:20

probability275:19

probably 19:1222:10 26:1133:12 36:3 38:2265:6 87:21


Page 51


105:15 126:17131:9 141:13145:2 179:13208:13 210:5216:22 218:6,7223:4 242:21244:12 250:21259:10 267:13272:3 273:10,13

probity 115:20

problem 8:1420:17,19 39:1377:11 79:2089:11 91:9 96:2143:20 178:8196:22 221:22255:15270:18,20274:10 275:10276:1

problematic114:11 129:2

problems 8:1314:14 17:1129:15 42:4 55:172:10 88:9161:22 197:21199:11 221:4239:6 241:18257:3 263:15265:4 267:22269:22

procedure 109:1127:4

procedures 2:14109:21127:1,5,7,10136:15 194:14

proceeding 147:15279:3 280:6,7,10

proceedings279:4,6

process 40:2049:17 54:356:3,10 60:1866:19 67:8 78:1679:8 107:6108:6,21109:20,21110:22 111:10112:6,15 113:1,4118:15121:9,18,19122:15 124:11125:2,3,5,11,12126:7,10,13134:2,7 137:9141:21 145:9149:10,19152:16 183:4197:14 207:20242:16 243:19260:13,22

processes 50:12126:22 127:5,7,9147:2 194:14227:6

processing 68:4161:8

produce 44:10

produced 47:17148:19 157:7265:13 268:22

produces 156:2

producing 153:10216:8

product 1:7 6:531:18 34:1547:20 48:1555:5,9 56:5,1559:8 60:5,19,2061:20 62:3 63:2066:3,13,18 67:1969:2,17 77:13

78:17 79:882:5,8 90:1492:7 94:7,1299:3 127:16139:5 141:16,19142:4 145:4146:1 148:18149:5,14 164:9165:9,11 170:5201:11,12,15,16,19 216:16219:4,12 223:20224:19 227:3,15233:11 238:22240:3,14 244:6260:10,22264:21 265:3268:1,15 269:11274:4

production 101:10194:14

products 7:4,99:14 15:13 18:1519:11 21:2 22:1726:1 30:5 32:1,533:4,7,1134:8,11,1935:2,21 39:10,1148:17 49:6,9,1350:14 52:6,753:9 54:2055:3,1858:6,7,10,12,14,15,17,20,2159:2,5,12,1960:12,1361:2,9,1462:15,2163:3,4,15,1864:7,9,10,16,2265:5,13,19,2066:5 68:9,16,2169:4,11 70:275:16 76:12

77:3,10 78:279:1,1382:9,10,12 85:2188:6 89:1991:2,12,16,2192:12,1593:2,4,694:2,6,1095:5,9,11,14,1696:17 98:19,2299:5,11,15 114:6122:13 131:4,6,9136:9 137:20138:19 140:2,6142:12 143:9145:15 147:19148:5,12,18,21149:4,7,15159:19 160:16161:4 162:1163:16,19 164:9165:14 166:19169:19,20170:4,16171:7,10,12,16,18 174:9,14,20176:21 177:13180:8,12,14,15,16,17182:12,15,17184:6 186:4187:8 188:7,16190:1,5 192:7194:22 195:7196:2 197:22198:21 199:7201:21207:11,19209:12 211:1214:7 215:13216:5,8,11,12217:1,8,19218:22219:1,9,10,15,21,22


Page 52


220:1,2,19,22221:6,10,16222:3,5,20223:2,14224:7,12 229:22230:1,8,13231:20 235:3236:5 237:2,13238:20 239:3,11240:20 242:3,5243:1,4,12,14,15260:7,8,15263:16 264:1,3265:8,14,22266:8,10 267:2268:4,11,20269:17270:4,10,16271:3 272:6274:1 275:3

product's 227:22

Products 2:17,194:10 9:18 57:1958:2 94:17,19

profession 45:351:12 241:10

professional 2:36:11 145:4169:8,11 175:6

professionalism225:17

professionally234:15 273:18

professionals20:16 63:9 64:384:17,20 150:1

professions 51:10

professor 12:3,570:22 169:1173:3 187:15

professors 258:8

profile 27:3 190:6198:19

profound 154:5

program 12:8,1513:4 20:2 23:345:4,10 124:9

programmatically45:7

programming67:2

programs 145:21148:15

progress 176:14

prohibition 140:5

prohibitive 244:4

projected 122:11

projects 202:9

prominent 50:22

PROMIS 196:5

promise 226:20231:10,13

promote 7:6 44:8

promoted 127:17

promoting 58:11

prompt 138:5

promptly 97:1599:17 151:14212:13

promulgated113:17

pronounced 70:13154:8

proof 141:17

proper 202:17237:2 238:18263:1

properly 243:9

properties 110:14153:16 154:14157:10 160:16

property 147:2206:5

proportion 189:22

proposals 59:14

propose 31:1154:12 161:5167:5

proposition268:20

propriety 132:4

prostate 237:8

protect 7:6 44:851:22 61:10

protecting171:5,19

protection 49:2151:21 61:12170:16 275:18

protects 47:22

protocol 196:6199:17

protocols 200:5244:13

proud 57:16 83:22117:10

proved 14:12

provide 7:1 32:838:8,13,15 47:1559:10 61:1,763:18 66:8 67:1668:15 75:1 77:478:13 90:198:16,20 100:2116:21 129:21146:18 171:15

174:22175:11,18 178:2213:18 217:22228:18

provided 51:1754:4 113:5211:10 258:19

provider 15:1232:1 75:15 85:19173:22205:11,15250:19

providers 19:1033:9 44:13 77:279:12 91:11,15175:15 176:17177:19 178:9189:5 206:11238:14 252:10257:21

provides 59:6 93:8113:19 114:2

providing 8:359:20 99:8143:17

proving 30:21110:13,17120:12156:13,20157:4,6162:1,4,8,13,21163:3 196:2

provings 40:15111:13 196:1

provision 172:5

provoked 147:12

proximity 223:20

pruned 93:12

psychiatric 256:11

psychiatry 173:4,8


Page 53


public 7:2,6 8:944:8,21 47:2249:21,22 51:4,2161:10 63:964:2,4 99:22101:12 107:17130:5 136:3,21145:8 146:10,12150:9 170:17171:5,19 172:7174:18 175:21176:17 183:17184:1 207:13208:14 241:1247:2 249:8257:18 271:12279:1,18

publication 100:9101:8

publications 175:1197:15

publicized 187:13

public's 216:12

publish 74:6104:13

published 13:1435:11100:11,18,21101:5 105:3107:5,7118:10,20 119:7185:14 186:14187:19190:11,12,21227:4 247:21256:5,13

publishes 179:18

pulling 277:8

pulmonary 70:2171:19 72:1074:19,20

pulmonologist71:16

pulmonology13:16 71:4 74:11

purchase 174:8

purchases 229:21230:7

purchasing227:15 230:22240:7

purity 48:14109:19

purple 193:6

purported 132:20

purpose 49:2175:3 84:5 155:17204:1

purposes 138:17143:22 144:2,6

pursuant 180:19

pursue 37:9

push 261:5

puts 133:14

putting 57:6

Qqualification

178:10

qualifications110:18

qualified 180:20

qualify 194:3

quality 2:14 3:69:9 10:6 47:1548:14 54:966:18,19 78:3,1790:14 91:1992:10 93:21

95:1,2 98:1899:4,9,20 101:11106:19 107:5109:19 111:5,20113:2,21 123:8171:15 175:20194:10,16 211:1216:8 217:3220:22 221:1228:19 241:8243:6,20255:20,21 267:3

quarter 1:9 98:21198:8

Quarter-Century6:8

quartet 168:11

Queen 248:13259:17

Queen's 276:9

question 7:1815:11 18:1219:9,13 21:928:12 32:7 40:1053:17 54:1055:12,13,15,1757:2 61:20 65:1169:6,8 76:11,2278:21 82:4 85:1889:16 91:10105:5 117:22118:6 121:7122:10 124:9125:8,10,19126:18 136:11142:6 161:14162:12,17165:4,7 166:5,15168:5 172:10182:22 184:5193:12 194:19197:19 198:16199:6 200:7,9,13

205:10 206:8207:3 208:3,19213:8 220:16223:18 229:5,19230:10,11 231:9237:20 251:9253:9 257:20275:15 276:3

questioning 57:17119:11

questions 8:4,1715:1021:15,16,1722:13 46:1852:9,20 74:475:13 78:9 79:2080:11 85:1786:18 87:7 88:993:19 116:4117:15 118:2124:2,22 132:4141:7 143:1150:3 151:8166:17 192:16193:2 198:3203:11210:15,17211:10 212:4,18213:4,7,11217:11,17228:22229:11,12239:17 240:8241:20 250:17260:1 261:13273:7 277:20

question's 39:9

quick 39:10 125:8196:21 223:17

quicker 254:21

quickly 215:16,20217:9 251:17


Page 54


quite 18:11 189:13252:6 253:10262:8 263:21266:2

quote 36:19135:12

RR.N 2:5

Raby 4:511:9,15,20

Rachel 89:7

radical 30:17

raise 105:6

raised 137:6 141:6182:22 250:17251:9

Rampes 185:14

ran 214:3

randomized 41:11121:10 253:22256:17

range 13:1 45:2046:10 87:10162:2 204:13278:3

ranged 187:20

rate 187:10 228:8254:17

rates 228:2229:6,11

rather 29:10 67:7134:1,18 149:20157:4,12 185:6186:1 189:11240:13 255:4277:16

rational 128:14

raw 123:9

RCTs 186:8

Rea 7:10,11,13

reach 192:17,18

reaching 194:11

reaction 155:11156:3,8 274:8

reactions155:16,17185:10187:2,6,10,22197:20 198:9,10

reading 88:12218:20 219:8,17222:2

real 16:7 87:1588:12 132:21133:21 136:11142:6 274:12

reality 271:9

realize 217:14

realized 71:20

really 7:21 8:537:19 54:2067:10 79:1881:13 86:9 96:20121:2 124:10128:15,17,22133:8 147:6,16188:14 194:9208:19 210:9211:3 213:18217:10 219:5221:21 222:15230:20 231:2,5240:22 242:16248:11 257:18264:15 277:22278:8

reason 10:20

135:20 150:4164:8 175:9192:18 196:20242:13 243:17252:12

reasonable 138:4150:9

reasons 48:6 59:373:13 132:17135:2 228:20239:16 240:5

reassuring 15:8

recall 147:9200:16 267:11

recalls 62:22

receive 16:22137:21 265:15

received 43:1861:16 116:20145:2 187:8

receives 62:1

receiving 201:18

recently 190:10247:20 252:6253:10

receptor158:1,19,21159:6 167:2

recess 97:17151:15 212:15

recognizable56:12

recognize 8:2151:5 56:10 106:1119:18 152:18246:13 273:10277:5,14

recognized 45:855:22 58:22

104:10127:17,21136:14 141:20170:22 182:5257:9

recognizing 266:6267:20

recommend 22:430:7 37:6 51:2052:3 55:2,2167:6 69:1 79:1182:11 95:4 112:2174:10 237:21238:8 243:1249:2

recommendation54:12 56:8 93:3

recommendations47:15 67:17191:12 247:15

recommended90:18 93:7207:15 235:12

recommending62:22

reconcile 199:4

record 18:6 25:2194:4 110:21202:21 268:17279:7

recorded 30:2231:1 279:4

recordings 280:8

records 62:4,863:12 66:15204:11 253:20

recovery 254:21

recurrent 73:19255:14


Page 55


red 162:8

redeem 259:11

redeemed 259:20

reduce 81:7,8249:6

reduced 279:5

reduces 257:16

reducing 86:14185:10 275:18

reduction 154:17239:14 249:10255:19

re-examine 131:14

refer 7:14 45:1975:19,20 85:6,790:16 205:16210:7 212:19

reference 21:11109:22 175:12269:7,15

references 21:21103:12 104:3

referral 173:11

referrals 74:19

referred 89:15

referring 82:9181:13 259:6

refers 118:17

reflect 214:12

reflected 105:1

reflects 63:4

regard 169:18170:15 173:22267:17 274:19275:3,7

regarding 21:2149:12 55:4 62:9

108:10 139:8175:10 184:6208:4 273:17

regardless 139:14

regards 18:1927:2 231:9

regime 241:12

regimen 14:17170:9

regionally 45:4

register 8:4 59:1860:8 75:14106:15 131:12134:22 135:14137:5 205:1220:10,13250:18

registered 50:10179:21 233:15

registration 59:2184:18

registrations 60:5261:8

registrator 261:9

regular 69:2218:22 219:19

regulate 123:19125:10,13126:4,10 163:18

regulated 77:678:2 97:5 105:17131:15179:14,15

regulating 58:5103:9 265:2

regulation 1:7 6:637:20 51:8 59:492:11 93:4 96:7103:6 125:22

139:8 145:11170:15 207:22233:11

regulations 15:762:7 92:20 95:8103:3 104:13105:2 170:18181:17 208:4216:11,21 243:2

regulator 114:19128:21 148:4269:9

regulators 263:18

regulatory 1:92:7,11,20 3:3 6:77:4 8:7 9:5,6,1510:2 44:9,1447:18 51:1756:14 57:859:7,9,13,2060:18,22 61:663:2 64:6,8 67:868:10,14 93:195:13 96:1699:7,18 100:5102:17 113:16115:22 137:2150:7 160:2,19161:12 165:8,10171:4,13 172:13179:8,12 181:9183:3 200:19205:4 208:5,15227:6 263:15266:8,21269:16,22 270:4271:10 273:2275:11 276:1278:11,12

reimbursed 83:1234:3

reinvent 244:7

reinvigoration132:13

reiterate 75:9179:11 189:21

reiterated 179:10

rejected 103:19147:3

relate 149:18184:18

related 54:9 67:382:4 104:17106:16 148:17191:16 192:4193:11 209:3219:18 279:9

relates 128:4,7

relating 278:12

relationship 11:1662:2 103:9105:19 131:21132:7,14 193:13231:18,20232:12 265:17

relationships 44:2115:22 116:3,11129:22 202:22216:15 231:16272:20

relative 151:4279:11

release 147:11,16161:5

release-active161:9 163:14

released 94:8

relentless 36:5

relevance 108:21

relevant 112:19171:21


Page 56


reliability 95:2175:19 194:7

reliable 33:2178:13,15,19 84:987:5 91:19176:22 269:12275:4

reliably 34:5

reliance 73:6

relied 236:6

relief 30:14 224:13228:5

relieve 218:19

rely 67:22 79:4227:5 231:13

relying 194:13

remaining 188:12

remarkable 67:10189:11

remarkably131:11 273:19

remarked 135:15

remarks 4:3 5:176:2 7:12 8:18113:12 128:6130:9 276:19

remedies 64:21121:12 122:5188:3 201:9209:10

remedy 120:9121:22 201:22202:1 238:7

remember 6:1811:2 16:20119:10,21124:13 151:22264:19 266:14273:11

remind 6:17 10:13

reminded 33:13

remote 146:10

remotely 35:18

remove 135:5136:16

removed 56:21134:15

removing 31:1237:6 171:12

renal 257:9,10,11

renders 54:4

renew 60:4

rent 220:15

repackaging262:16

repeat 55:13 69:5125:19

repeated 254:19

repertory 31:4,6

replace 68:3

replaced 215:21

replacement 249:3

replicated 118:12

report 7:19 61:19179:5 184:13187:12 196:9209:19 249:20250:7

reported 1:2035:12 62:5 148:5188:3,18 192:8195:10 280:5

Reporter 280:5

Reporter's 280:7

reporting 1:2161:13,18,22 63:7

179:3 187:10196:10

reports 61:1662:8,14 63:11111:14 185:21186:3,22187:2,18188:3,5,7,21197:11,12 201:1253:22

represent 153:4178:9 185:5188:8 207:19226:8,14,19227:2 228:16232:2 262:1

representation143:8 225:22226:2

representative104:16 145:3217:15

Representatives117:1

represented129:14 130:14191:5

representing 28:658:22 82:22202:9 225:9232:14

represents 46:13145:14 190:16

Republic 251:14

repurchase 219:6227:11,12228:2,8229:6,10,13

repurchased215:18

reputable 94:22

reputation226:16,22232:10

request 62:10192:16 243:12

requesting 277:18

require 38:20112:10 115:1,2118:7,9 121:20139:16 142:19160:1 244:14

required 62:9121:20 149:2242:17 255:1

requirement126:19 134:6160:19

requirements60:8,14 61:12,1669:16 95:1396:16 111:16112:13 132:8269:2

requires 36:5 46:959:16 62:4167:21

requiring 114:10

research2:3,10,12,15,173:4,6 6:13 50:1081:1 87:13120:22 134:11135:7 176:22177:1 179:3181:9,10183:9,21 184:10185:12 192:5196:17,19198:18,21199:9,12 203:21


Page 57


210:2 222:3,9227:1,7 246:21253:14 254:3,5266:13,14270:22

researched 79:6232:11

researcher 183:14

researching 110:7219:21 240:6

residency 47:12

residents 18:2

resistance 257:17

resolve 42:5

resolving 146:12

resorted 207:12

resounding 258:1

resource 116:18117:8 177:15212:6

resources 52:4135:3,11 136:4137:1 146:10175:13 199:22206:20 211:11214:18 275:11

respect 18:2026:18 56:1 57:990:6 127:19145:8 260:6

respective 158:12169:17

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Ssadly 132:12

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