FDA has made several efforts to secure the pharmaceutical supply chain: 1. The Office of Compliance within CDER was reorganized to better address threats like counterfeiting, diversion, and intentional adulteration. A new Office of Drug Security, Integrity, and Recalls was created. 2. Preliminary analysis of FDA criminal case information from 2003-2008 found that the top five branded drugs targeted were Zyprexa, Viagra, Lipitor, Zoloft, and Risperdal, and that solid oral dosage forms were most at risk. 3. FDA is working on track and trace standards and held a public workshop on the topic in 2011. A track and trace system

1. FDA Efforts to Secure the
Pharmaceutical 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. 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. 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. Compliance Sub-Office Structure
CDER
Office of Compliance
Office of
Office of Drug Office of
Office of Scientific Unapproved Drugs
Security, Integrity Manufacturing and
Investigations and Labeling
and Recalls Product Quality
Compliance
Div. 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. 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. 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. 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. Three Criminal Drug Schemes Revealed
1) Counterfeit Scheme

9. Three Criminal Drug Schemes Revealed
2) Diversion Scheme Involving a Wholesale
Distributor

10. Three Criminal Drug Schemes Revealed
3) Diversion Scheme Involving a Pharmacy and
Pharmacist

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. Summary of Preliminary Results
Suspect 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. Standards Development
• FDA’s First Step – SNI Guidance
Released March 2010
• Public Workshop on Track and Trace
Held in February 2011

14. ILLUSTRATIVE
Overview of a Track and Trace System
Manufacturer/
Distributor Distributor Pharmacy
packaging line
or
- 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. Track and Trace System Goals
1. Preventing the introduction of counterfeit, diverted, subpotent,
substandard, adulterated, misbranded, or expired drugs
2. Facilitating the identification of counterfeit, diverted,
subpotent, substandard, adulterated, misbranded, or expired
drugs
3. Providing accountability for the movement of drugs by supply
chain participants
4. 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. 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. 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. 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. THANK YOU!
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