20th annual gmp by the sea compliance and enforcement · food / cosmetics human drug medical device...
TRANSCRIPT
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
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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)
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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
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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
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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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