Impact of the PDMA on the
Pharmaceutical Supply Chain

Ilisa B.G. Bernstein, PharmD, JD

U.S. Food and Drug Administration

NACDS/HDMA RFID Adoption Summit

November 13, 2006

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Overview

• Counterfeit update

• PDMA

  • Background

  • Compliance Policy Guide

  • Question and Answer Guidance

• FDA PDMA Resources webpage

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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

 

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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

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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)]

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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

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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

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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

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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

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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

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Recordkeeping requirements

• Pedigree recipients

  • Depends if Rx drug is further distributed

  • Encouraged to retain for 3 years

• ADR from non-ADR

  • 3 years

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PDMA Scope

• Veterinary prescription drugs

  • No

  • If human Rx drugs--yes

• Drug samples - no

• Medical convenience kits - yes

• Bulk drug substances - yes

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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

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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

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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

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Pedigrees

• “Date of previous transaction”

  • date or prior sale, purchase, or trade

• Compliance

  • Paper or electronic?

  • FD&C Act -- Technology neutral

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Compliance/Enforcement

• Reporting concerns

  • FDA

• Examples of issues that might raise concerns re: pedigrees

• CPG application

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PDMA Resources Website

• PDMA and PDA

• Legislative history

• Relevant regulations

• Regulatory history

  • Federal register notices

• 2001 Report to Congress

• Relevant guidances

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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