Scott J. MacIntire

Director, Division of EnforcementFDA Office of Regulatory Affairs

20th Annual GMP By The SeaCompliance and Enforcement

August 29-31, 2016

Topics to Include

• Globalization

• ORA Inspection Data

• Newer Regulatory Authorities

• Compliance & Enforcement Statistics

• Trends

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Domestic Inspections FY 2011-2015(All Commodities)

0

4000

8000

12000

16000

20000

2011 2012 2013 2014 2015

19498 19243

16999

11296 11319

3

Foreign Inspections FY 2011-2015

0

500

1000

1500

2000

2500

3000

3500

2011 2012 2013 2014 2015

2227

27122852

3011

3331

4

Domestic Inspections by Program Area

5

0

2000

4000

6000

8000

10000

12000

2011 2012 2013 2014 2015

Food / Cosmetics

Human Drug

Medical Device & RadHealth

Biologics

Animal Drugs and Feeds

Foreign Inspections by Program Area

6

0

200

400

600

800

1000

1200

1400

1600

2011 2012 2013 2014 2015

Food / Cosmetics

Human Drug

Medical Device & RadHealth

Biologics

Animal Drugs and Feeds

Newer Regulatory Authorities

FSMA

• Administrative detention – 304(h) – Used for firm making drinks that contain Sceletium Tortuosum (a “new

dietary ingredient”) and

– 2 firms making an herbal dietary supplement containing Kratom, mitragnyna speciosa leaf extract

– Ongoing surveillance? DEA taking jurisdiction?

• Suspension of food facility registration – 415(b)– One firm (2012) with Salmonella in peanut butter

– One firm (2013) with Listeria monocytogenes in RTE cheese

– One firm (2014) with Listeria monocytogenes in HPP items, frozen food, sandwiches, and salads

7

FSMA Authority, Con’t

Administrative Enforcement Tools• Mandatory recall -- 423 Section 206(a) of FSMA gives FDA

mandatory recall authority for all FDA-regulated foods other than infant formula. Prior to FSMA food recalls (except infant formula) were voluntary.

FDA must determine

– “reasonable probability” that the food is adulterated under section 402 or misbranded under 403(w) AND

– the use of or exposure will cause serious adverse health consequences or death to humans or animals (SAHCODAH)

8

FDASIA Implementation: Selected Accomplishments

• Section 705 (6) – requires risk based schedule for inspections of drug establishments.

• Section 708-- authorizes FDA to destroy a drug that has been refused admission.

• Section 709-- authorizes FDA investigator to issue detention order for drugs that “FDA has reason to believe are adulterated or misbranded”

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Compliance Activities

• Recalls

• Health Fraud

• Imports

• Warning Letters

10

Class I Recalls

11

Class II Recalls

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FDA Definition of Health Fraud

• The deceptive promotion, advertisement, or sale of products as being effective to diagnose, prevent, cure, treat, or mitigate disease, or to provide a beneficial effect on health, but which have not been scientifically proven safe and effective for such purposes.

• May be deliberate, or done without adequate knowledge or understanding of the product.

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• CDER: Online pharmacies and tainted products

• CDRH: Laser and sunlamp testing

• CVM: Distributors of unapproved omeprazole

• CFSAN: DMAA/DMBA/BMPEA, kratom, powdered caffeine,

• Multi-Center:

– Products marketed for Ebola, diabetes, radiation (Fukushima Dai-ichi Nuclear Power Facility Incident), STDs, H1N1

• FDA & FTC jointly issued warning letters

– Products containing cannabidiol (CBD)

– Beginning to see products marketed for Zika?

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FDA Health Fraud Initiatives

Dangerous Drug Levels & Combinations for Weight Loss

Bethel 30 • Sibutramine – 84.2mg/cap

• Phenolphthalein – 88.9 mg/cap

• Consent decree – part of DOJ and federal partners Dietary Supplement Enforcement initiative (Nov 2015)

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•Dr. Mao Slimming Capsule Sibutramine – 115.1 mg/cap

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Tainted Sexual Enhancement Products

MORE SEPs

Warning Letters FY 2011-2015 FY 2015 by Center

18

0

2000

4000

6000

8000

10000

12000

14000

16000

18000

0

50

100

150

200

250

CFSAN CDRH CVM CDER

Imports Data

Detentions Refusals

Regulatory Meetings and Enforcement

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FY Regulatory

Meetings

Injunctions Seizures Debarments

2015 138 29 2 11

2014 172 16 3 1

2013 170 19 3 8

2012 135 34 16 18

2011 118 33 11 15

Thank you.

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