FDA Efforts to Secure theFDA Efforts to Secure the Pharmaceutical Supply Chain

Michael Levy, Esq.Acting Director, Office of Drug Security, Integrity, &

Recalls CDER/Office of ComplianceFood and Drug Administration

Partnership for Safe Medicines 2011 InterchangeOctober 27, 2011

Agenda• FDA Efforts to Secure Supply Chain

– Reorganization of CDER’s Office of gCompliance

– Diversion/Counterfeit Criminal Case Information

– Track and Trace– International Internet Week of Action– Secure Supply Chain Pilot Program

CDER/Office of Compliance Reorganizationg

• Super Office Structure – reflects growth and increased responsibilitiesp

• 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)intentional adulteration)

Compliance Sub-Office StructureCDER

Office of ComplianceOffice of Compliance

Office of Drug Security, Integrity

and Recalls

Office of Unapproved Drugs

and Labeling Compliance

Office of Manufacturing and

Product Quality

Office of Scientific Investigations

Compliance

Div. Prescription DrugsDiv. Import Operations & Recalls

Div. International Drug Quality

Div. Bioequivalence & GLP Compliance

Div. Non-Prescription Drugs & Health Fraud

Div. Supply Chain Integrity

Div. Domestic Drug Quality

Div. Policy, Collaboration & O

Div. Good Clinical Practice Compliance

Div Safety ComplianceData Operations

Div. GMP Assessment

Div. Safety Compliance

Office of Drug Security, Integrity & Recalls (ODSIR)

Office Director(A: Mike Levy)

Deputy Director Vacant

Division of Import Division of Supply Ch i I t itDivision of Import

Operations & Recalls‡

Chain IntegrityVacant

Recalls Coordination Branch

Import Operations

Branch Import Policy Team

Drug Component

Security Team

Finished Drug Security Team

A: = Acting ‡ DIOR & IOB renaming under consideration

Office of Drug Security, Integrity, and Recalls

• Enhanced and targeted resources Add i i l h i th t• Address increasing supply chain threats– Intentional adulteration, cargo theft,

counterfeiting diversion othercounterfeiting, diversion, other• Focus on life-cycle of the product from

drug components through to the finisheddrug components through to the finished dosage from delivered to the patient

• New and coordinated approaches, pp ,policies and enforcement strategies

Preliminary Review of FDA’s Diversion and Counterfeit Criminal Case Information

• Report released September 2011• Analyzed OCI counterfeit and diversion cases• 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 incidentsR t id h t f ill l di i• Report provides a snapshot of illegal medicines trade in the US rather than a comprehensive analysisanalysis

Three Criminal Drug Schemes Revealed

1) Counterfeit Scheme

Three Criminal Drug Schemes Revealed

2) Diversion Scheme Involving a Wholesale Distributor

Three Criminal Drug Schemes Revealed

3) Diversion Scheme Involving a Pharmacy and Pharmacist

Summary of Preliminary ResultsTop five brand products identified:1. Zyprexa2. Viagra3. Lipitor4 Zoloft4. Zoloft5. Risperdal

Solid oral dosage forms (tablets and capsules) most likely to be targeted by counterfeiters/diverters

Summary of Preliminary Results

Suspect Trade:Wh l l 27%

Suspect Type:I di id l 86%• Wholesalers – 27%

• Pharmacists – 13%• Individuals – 86%• Company – 14%

• Doctors – 9%• Sales reps – 5%• Other pharmacy

workers – 4%

Standards Development• FDA’s First Step – SNI Guidance

Released March 2010Released March 2010

• Public Workshop on Track and Trace Held in February 2011

Overview of a Track and Trace SystemILLUSTRATIVE

Manufacturer/Distributor Pharmacy

Manufacturer/packaging line Distributor

or

- Track product- Authenticate

- Serialize- Record SNI and

product info

- Track product- Authenticate

- Track product- Authenticate

T k d t d t b

product info

Track and trace databasecentralized or decentralized (distributed)

Track and Trace System Goals1. 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.

International Internet Week of ActionOPERATION 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

medicinesmedicines• Goals:

– Increasing public awareness of purchasing medicines onlineId tif i d d di t ib t f t f it– Identifying producers and distributors of counterfeit or otherwise illegal pharmaceutical products or medical devices

– Seizing counterfeit and illegal products

International Internet Week of ActionOPERATION 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 packages seized and 2 4 million illicit and counterfeit pills• ~8,000 packages seized and 2.4 million illicit and counterfeit pills

originating from 48 countries were confiscated – including antibiotics, steroids, anti-cancer, anti-depression and anti-epileptic pills, slimming and food supplement pillsand food supplement pills

• Criminal investigations for a range of offenses, including illegally manufacturing, selling, and supplying unlicensed or prescription medicationsmedications.

Secure Supply Chain Pilot Program• Two-year pilot program to determine practicality ofTwo year pilot program to determine practicality of

developing a secure supply chain program while expediting entry for specific imported finished drug products and APlsproducts and APls.

• Generally, companies wishing to participate must meet certain criteria, including:

FDA approved drug application or must be the foreign– FDA-approved drug application or must be the foreign manufacturer identified in an FDA-approved application.

– API imported must be used only to make FDA-approved drugsForeign drug manufacturers and U S establishments receiving– Foreign drug manufacturers and U.S. establishments receiving drugs must be FDA-registered and comply with good manufacturing practice

– Applicants must show that their drug products use a secureApplicants must show that their drug products use a secure supply chain

THANK YOU!THANK YOU!

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