direct-to-consumer prescription drug promotion nancy m. ostrove, ph.d. division of drug marketing,...
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Direct-to-Consumer Prescription Drug Promotion
Nancy M. Ostrove, Ph.D.Division of Drug Marketing,
Advertising, and Communications Food and Drug Administration
Overview
What we know– law– history– stakeholder concerns– enforcement problem areas– consumer/patient perceptions
What we don’t know– broad effects on the public health
Background Facts
No laws or regulations ever prohibited promoting prescription drugs to consumers
Law requires advertisements to include “information in brief summary” about product’s risks and benefits
Law generally prohibits preclearance
Types of Advertisements - 1
Help-seeking (“See your doctor,” disease oriented)– these are not drug ads
Types of Advertisements - 2 Reminder
– regulations specifically exempt from disclosure requirements
– include name of product, but no representations beyond dosage form and packaging, price information
– designed to remind knowledgeable persons of existence of product
Types of Advertisements - 3
Product-claim -- includes– name and quantitative information
– product use (indication)
– optionally, other substantiated claims
– risk disclosure (requirements vary as a function of whether print or broadcast)
Law Focuses on Content of Ads Can’t be false or misleading Must present “fair balance” between
benefits and risk information Can’t omit “material” facts
Plain language meaning: Ads must communicate an accurate and balanced picture of the product
If the law allowed ads to be directed to consumers, why
didn’t we see them until relatively recently?
Things Changed Consumer empowerment
– desire for involvement in own care– active information seeking
Aging baby-boomer population
– selves, children, parents Managed Care Increasing focus on First Amendment
Evolution of DTC
Up to 1980s -- “learned intermediary” only 1983 - 1985 -- voluntary moratorium 1985 - regulations provide “sufficient
safeguards to protect consumers” 1990s - steady increases in print promotion mid 1990s - broadcast increasingly enters
mix
Broadcast Environment
Static -- sponsor uncertainty regarding requirement for “brief summary”
“Adequate provision” for providing labeling always allowed
– FDA never gave guidance on “how to” Major risks required to be disclosed
regardless of mechanism
Result was a confusing broadcast environment --
more and more uninformative “reminder” advertisements
“Adequate Provision” Guidance
How to reach diverse group of consumers? Sponsors had some suggestions 1997 draft gave possible approach, finalized
in 1999– reference to health care provider– print ads/brochures– telephone contact number– internet site
Perspectives
Stakeholder Perspectives - 1
DTC is good -- FDA should not over-regulate– PhRMA, individual pharmaceutical
sponsors– ad agencies and associations– communications groups– media providers (print, TV, radio, internet)– Federal Trade Commission (FTC)
Stakeholder Perspectives - 2
Mixed bag -- DTC may have some benefits but FDA should strictly regulate– some consumer/patient groups (e.g.,
National Consumers League)
– some health care professional associations (AMA, ACP/ASIM, APhA)
generally want FDA to preapprove promotional materials
Stakeholder Perspectives - 3
DTC is bad -- should be stopped– some consumer groups (e.g., Public
Citizen, Center for Medical Consumers, National Women’s Health Network)
– managed care (AMCP)– historically, generic manufacturers– Drug Enforcement Administration (DEA)
Focus of Arguments
Patient-physician interaction/relationship Prescribing behavior Patient knowledge about drugs Product costs
Current Situation
Close surveillance and quick enforcement Encourage compliance -- cooperate with
voluntary requests for pre-review and comment
Assessing impact
Enforcement Product efficacy claims
– broadening indication, patient population– overstating or guaranteeing efficacy– implying use without disclosing risk
Disclosure of product risks– content– presentation (minimization; fair balance)
“Adequate provision” mechanism
What is DTC’s Impact?
Little research until relatively recently– cost concerns (correlational analyses)
– effects on physician/patient relationship (self-report surveys)
FDA, Prevention, TIME Inc., NCL, AARP
– effects on patients’ knowledge about drugs (experimental designs, surveys)
– effects on prescribing behavior (?)
FDA’s Research
Patient/Physician interaction– is DTC influencing patient behavior?
2000 - national survey of patients’ behaviors and attitudes– www.fda.gov/cder/ddmac/research.htm
Methodology National probability sample
– focus on patients visiting doctor in last 3 months about a problem of their own
Telephone interview (n=1,081) Final sample
– 960 who had seen doctor in last 3 months
– 121 who had not
Demographics
More females than males; especially among those who had seen a doctor– 65% vs. 55%
Similar ethnicity and overall education among those who had and had not seen a doctor
Self-Reported Health
0 10 20 30 40
Excellent
Very Good
Good
Fair
Poor
Seen MD in last 3 months Not seen MD in Last 3 Months
Do Respondents Recall Seeing Advertisements?
Asked whether they had seen an advertisement for a prescription drug in last 3 months– 72% of those who had seen a doctor– 69% of those who had not seen a doctor
Not inconsistent with 1999 Prevention survey– 81% had seen an ad (no time limit)
Where Was Advertisement Seen or Heard?
(Multiple responses accepted)
n = 688
0 20 40 60 80 100
Internet
In the Mail
Radio
Newspaper
Magazine
Television 94%
66%
29%
28%
17%
9%
What Information is Recalled from TV Ads?
10%
63%
64%
76%
81%
82%
87%
0 20 40 60 80 100
Overdosage
Questions for doctor
Directions for use
Who should take
Who should not take
Risks/Side effects
Benefits
n=688
Information Seeking in Response to an Ad
0
10
20
30
40
50
60
Seen MD in Last 3Months
Not Seen MD in Last 3Months
Has an ad for a prescription drug ever caused you to look for more information, for example, about the drug or about your health?
51%
41%
Sources of Information Cited Mostly from health care professionals:
– own doctor (81%), pharmacist (52%), nurse (33%)
Reference book (36%) Friend, neighbor, or relative (30%) Toll-free number, internet (both 18%) Other print sources (magazine - 14%,
newspaper - 7%)
How Many Read the Brief Summary?
30%
26%
14%
11%
15%
3%
It was there?
None
A Little
About Half
Almost All
All
n=688
What if Especially Interested in the Product?
4%3%
8%
73%
12%
None
A Little
About Half
Almost All
All
n=688
Patient/Physician Interaction?
Patients report seeing their doctors for the traditional reasons– time for checkup (53%)– feeling ill (42%)– had symptoms (41%)
DTC not directly causing large numbers of visits
– read/saw something (2%)
DTC Encouraging Discussion?27%
8%
0
5
10
15
20
25
30
Seen MD in Last 3Months
Not Seen MD in Last 3Months
Has an ad ever caused you to ask a doctor about a medical condition or illness you hadn’t previously talked about?
Awareness Influences Asking
35%
16%
25%
6%
0
5
10
15
20
25
30
35
40
Seen an Ad Not Seen an Ad
Asked about a drugto treat condition
Asked about aspecific brand
How Did Doctor React?
0 20 40 60 80 100
Angry or upset
Reacted like ordinarypart of visit
Discussed drug
Welcomed question
Which of these possible reactions did your doctor have when you asked about the drug? n = 220
81%
79%
71%
4%
Feelings About Doctor’s Reaction
37%
48%
3%5%
2%
Very Unsatisfied
Unsatisfied
Neither Satisfied norUnsatisfiedSatisfied
Very Satisfied
n=220
What Did Doctor Do?
0 10 20 30 40 50
Other
Recommend OTC
Recommend no drug
Behavior/lifestyle chg
Recommend diff Rx
Gave Rx asked about
Did your doctor do one or more of the following? n = 220
50%
15%
14%
12%
29%
32%
Reason(s) Given for Not Prescribing Drug
For 59% who didn’t get requested drug prescribed, the doctor said why (n=65)– not right for patient
48%– wanted patient to take different drug 35%– side effects patient didn’t know 29%– patient didn’t have condition 23%– patient didn’t need prescription drug 20%– patient could use OTC drug 12%– less expensive drug available 8%
Trend Data
Annual national telephone surveys by Prevention magazine since 1997
No change in percentage of patients asking about a specific prescription medicine as function of DTC promotion– despite large increases in funding of DTC
promotion and in television advertising
DTC-Related Attitudes - 1(among patients)
Prescription drug advertisements:– help make me aware of new drugs
86%– give enough information for me to decide
whether I should discuss with MD 70%– help me have better discussions with my
MD about my health 62% Ads make it seem like a MD is not needed
to decide if drug is right for me 24%
DTC-Related Attitudes - 2(among patients)
Prescription drug advertisements:– help me make better decisions about my
health 47%
– make the drugs seem better than they really are 58%
– do not give enough information about:possible benefits and positive effects 49%possible risks and negative effects 59%
Summary Patients visiting doctors for traditional
reasons– time for checkup, symptoms, feeling ill– DTC not causing large numbers of visits
DTC appears to work– awareness associated with discussing
prescription medicine/specific brand with doctor
– prompts information-seeking and asking about conditions not previously discussed
Summary
Patients think doctors reacting well to discussion about specific products
Patients think doctors denying products where appropriate; many doctors providing reasons for denial
Patients see benefits as well as risks associated with DTC advertisements
Limitations of Existing Research
Survey data self-report -- subject to recall and other biases
Correlational data subject to causality problem
Experimental studies to date focused on narrow issues of knowledge of particular products -- used small samples
Meaning of content analyses?
Remaining Questions
Regarding public health: Is DTC causing health care professionals to prescribe inappropriately?
Regarding regulation: How can DTC ads best communicate drugs’ relative benefits and risks
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