FDA efforts to secure the pharmaceutical supply chain


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At the 2011 Partnership for Safe Medicines Interchange conference, Mike Levy from the US Food and Drug Administration talked about the FDA's efforts to secure the pharmaceutical supply chain.

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FDA efforts to secure the pharmaceutical supply chain

  1. 1. FDA Efforts to Secure thePharmaceutical Supply Chain Michael Levy, Esq. Acting Director, Office of Drug Security, Integrity, & Recalls CDER/Office of Compliance Food and Drug Administration Partnership for Safe Medicines 2011 Interchange October 27, 2011
  2. 2. Agenda• FDA Efforts to Secure Supply Chain – Reorganization of CDER’s Office of g Compliance – Diversion/Counterfeit Criminal Case Information – Track and Trace – International Internet Week of Action – Secure Supply Chain Pilot Program
  3. 3. CDER/Office of Compliance Reorganization g• Super Office Structure – reflects growth and increased responsibilities p• Adaptation to how the industry we regulate has changed• Globalization: We now regulate an international drug industry for the protection of U.S. citizens.• Growth of the international criminal enterprise (drug counterfeiting, diversion, cargo thefts, and intentional adulteration)
  4. 4. Compliance Sub-Office Structure CDER Office of Compliance Office of Office of Drug Office of Office of Scientific Unapproved DrugsSecurity, Integrity Manufacturing and Investigations and Labeling and Recalls Product Quality ComplianceDiv. Import Operations Div. International Drug Div. Bioequivalence & Div. Prescription Drugs & Recalls Quality GLP Compliance Div. Supply Chain Div. Domestic Drug Div. Good Clinical Div. Non-Prescription Integrity Quality Practice Compliance Drugs & Health Fraud Div. Policy, Collaboration & Div. Div Safety Compliance Data OOperations Div. GMP Assessment
  5. 5. Office of Drug Security, Integrity & Recalls (ODSIR) Office Director (A: Mike Levy) Deputy Director Vacant Division of Supply Division of Import Chain Integrity Ch i I t it Operations & Vacant Recalls‡ Import Recalls Coordination Operations Branch Branch Drug Import Policy Finished Drug Component Team Security Team Security Team A: = Acting ‡ DIOR & IOB renaming under consideration
  6. 6. Office of Drug Security, Integrity, and Recalls • Enhanced and targeted resources • Add Address increasing supply chain th t i i l h i threats – Intentional adulteration, cargo theft, counterfeiting, diversion, counterfeiting diversion other • Focus on life-cycle of the product from drug components through to the finished dosage from delivered to the patient • New and coordinated approaches, pp , policies and enforcement strategies
  7. 7. Preliminary Review of FDA’s Diversion and Counterfeit Criminal Case Information• Report released September 2011• Analyzed OCI counterfeit and diversion cases investigated between 2003-2008• Goal of analysis – to better understand methods y used by criminals and to help prevent future incidents• R Report provides a snapshot of illegal medicines t id h t f ill l di i trade in the US rather than a comprehensive analysis
  8. 8. Three Criminal Drug Schemes Revealed1) Counterfeit Scheme
  9. 9. Three Criminal Drug Schemes Revealed2) Diversion Scheme Involving a Wholesale Distributor
  10. 10. Three Criminal Drug Schemes Revealed3) Diversion Scheme Involving a Pharmacy and Pharmacist
  11. 11. Summary of Preliminary Results Top five brand products identified: 1. Zyprexa 2. Viagra 3. Lipitor 4. 4 Zoloft 5. Risperdal Solid oral dosage forms (tablets and capsules) most likely to be targeted by counterfeiters/diverters
  12. 12. Summary of Preliminary ResultsSuspect Trade: Suspect Type:• Wholesalers – 27% Wh l l • I di id l – 86% Individuals• Pharmacists – 13% • Company – 14%• Doctors – 9%• Sales reps – 5%• Other pharmacy workers – 4%
  13. 13. Standards Development• FDA’s First Step – SNI Guidance Released March 2010• Public Workshop on Track and Trace Held in February 2011
  14. 14. ILLUSTRATIVE Overview of a Track and Trace System Manufacturer/ Distributor Distributor Pharmacy packaging lineor - Serialize - Track product - Track product - Track product - Record SNI and - Authenticate - Authenticate - Authenticate product info Track d t T k and trace database d t b centralized or decentralized (distributed)
  15. 15. Track and Trace System Goals1. Preventing the introduction of counterfeit, diverted, subpotent, substandard, adulterated, misbranded, or expired drugs2. Facilitating the identification of counterfeit, diverted, subpotent, substandard, adulterated, misbranded, or expired drugs3. Providing accountability for the movement of drugs by supply chain participants4. Improving efficiency and effectiveness of recalls For discussion purposes only. Developed for use at FDA’s public workshop. The information should not be interpreted as a final decision or position of the FDA.
  16. 16. International Internet Week of Action OPERATION PANGEA IV• Largest global operation by INTERPOL – FDA, regulatory agencies from 81 countries participated• September 20-27, 2011• Targeted Web sites supplying illegal and dangerous medicines• Goals: – Increasing public awareness of purchasing medicines online – Id tif i producers and di t ib t Identifying d d distributors of counterfeit or f t f it otherwise illegal pharmaceutical products or medical devices – Seizing counterfeit and illegal products
  17. 17. International Internet Week of Action OPERATION PANGEA IV International Results• 13,500 websites engaged in illegal activity were shut down , g g g y• FDA shut down 578 internet drug outlets• 45,500 packages inspected by regulators/customs• ~8,000 ~8 000 packages seized and 2 4 million illicit and counterfeit pills 2.4 originating from 48 countries were confiscated – including antibiotics, steroids, anti-cancer, anti-depression and anti-epileptic pills, slimming and food supplement pills• Criminal investigations for a range of offenses, including illegally manufacturing, selling, and supplying unlicensed or prescription medications. medications
  18. 18. Secure Supply Chain Pilot Program• Two-year pilot program to determine practicality of Two year developing a secure supply chain program while expediting entry for specific imported finished drug products and APls. APls• Generally, companies wishing to participate must meet certain criteria, including: – FDA approved drug application or must be the foreign FDA-approved manufacturer identified in an FDA-approved application. – API imported must be used only to make FDA-approved drugs – Foreign drug manufacturers and U.S. establishments receiving US drugs must be FDA-registered and comply with good manufacturing practice – Applicants must show that their drug products use a secure supply chain
  19. 19. THANK YOU! 19