Overview

Counterfeit update

PDMA

• Background
• Compliance Policy Guide
• Question and Answer Guidance

FDA PDMA Resources webpage

Counterfeit drug cases opened by FDA per fiscal year

Number of Cases and Year

1997 - 9
1998 - 5
1999 - 11
2000 - 6
2001 - 21
2002 - 27
2003 - 30
2004 - 58
2005 - 32
2006 - 53

Prescription Drug Marketing Act (PDMA)

Federal pedigree requirement:

Each person who is engaged in the wholesale distribution of Rx drugs and who is not the manufacturer or authorized distributor of record, shall, prior to each wholesale distribution of such drug, provide a statement to the person who receives the drug identifying each prior sale, purchase or trade of such drug.

• [21 USC 353(e)(2)(A)]

State pedigree requirements differ

PDMA background

The Federal Food, Drug, and Cosmetic Act defines authorized distributor of record as a distributor with whom a manufacturer has established an “ongoing relationship.

• [21 USC 353(e)(3)(A)]

PDMA background

1999 final rule provisions that are stayed until December 1, 2006:

• 21 CFR 203.3(u): “Ongoing relationship” defined to include a written agreement between manufacturer and wholesaler
• 21 CFR 203.50: specifies the information to be included in the drug pedigree; information to be traceable back to 1st sale by manufacturer

PDMA Compliance Policy
Guide 160.900

Focus: Drugs most vulnerable to counterfeiting and diversion

Final: Very minor changes from draft CPG

Factors to consider by FDA field personnel regarding where they should target their enforcement efforts and prioritize resources.

Risk-based focus with examples

• High value in US market
• Prior history of counterfeiting or diversion
• Reasonable probability for new drugs

Other violations of law

NOT an excuse for non-compliance

PDMA Question and Answer Guidance

Authorized distributor of record (ADR) status

Pharmacy/end user responsibilities

Recordkeeping requirements

PDMA Scope

Returns

Shipping/Delivery arrangements

Inventory

Pedigrees

Compliance/enforcement

ADR Status

Written agreement

• What info goes into agreement? What constitutes an agreement? How maintained?

ADR list

• Who? Where? When updated?

Providing pedigree information

• If manufacturer? If ADR?
• “SOME MUST….ALL SHOULD” – shared goal to secure drug supply chain

Definition of manufacturer

• Contract manufacturers/NDA holders

Pharmacy/End User Responsibilities

Providing Pedigree – prior to each wholesale distribution

• To physician’s offices - yes

Pharmacy sales – depends

• Limited exceptions

Pharmacy intra-company transfers/sales -no

Pedigree verification/authentication – no

• Encourage due diligence

Recordkeeping requirements

Pedigree recipients

• Depends if Rx drug is further distributed
• Encouraged to retain for 3 years

ADR from non-ADR

• 3 years

PDMA Scope

Veterinary prescription drugs

• No
• If human Rx drugs--yes

Drug samples - no

Medical convenience kits - yes

Bulk drug substances - yes

Returns

Enforcement discretion

Pharmacy or physician’s office

• No pedigree IF:

  • Returned to wholesaler/manufacturer where purchased or licensed reverse distributor for destruction; and
  • Maintain documentation of return and source of drugs for 3 years
• If Rx drugs are in saleable condition and may be resold- then wholesaler or RD would pass pedigree if not ADR

Hospitals, health care entities, charitable institutions – returns per 21 CFR 201.23

Shipping/Delivery Arrangements

Drop shipments

• Mfg to pharmacy on behalf of non-ADR -yes
• ADR to customer on behalf of non-ADR - yes

Third party logistics providers

• Yes, but most are ADR

Inventory

Pedigree required for Rx drugs sold, purchased, traded by non-ADR as of December 1, 2006

• 6 months notice

BUT: Enforcement discretion – until April 1, 2007

• If ADR when Rx drugs were purchased, but non-ADR when sold

  • Documentation that drugs purchased prior to Dec. 1, 2006
  • Documentation that purchased same type of drugs from same mfg on at least 2 occasions in previous 24 months

Inventory acquired via merger, buyout, acquisition

Pedigrees

“Date of previous transaction”

• date or prior sale, purchase, or trade

Compliance

• Paper or electronic?
• FD&C Act -- Technology neutral

Compliance/Enforcement

Reporting concerns

• FDA

Examples of issues that might raise concerns re: pedigrees

CPG application

PDMA Resources Website

PDMA and PDA

Legislative history

Relevant regulations

Regulatory history

• Federal register notices

2001 Report to Congress

Relevant guidances

Conclusion and Questions

Ilisa B.G. Bernstein, PharmD, JD

Director of Pharmacy Affairs

U.S Food and Drug Administration

5600 Fishers Lane HF-11 14C-03

Rockville, Maryland 20852

301-827-5595

Ilisa.bernstein@fda.hhs.gov