In conjunction with the FDA’s recent release of its Counterfeit Drug Task Force Report (2006 Update), in the Federal Register of June 14, 2006, the FDA announced that it did not intend to delay further the effective date of the “pedigree provisions” of the FDA’s regulations implementing the Prescription Drug Marketing Act (“PDMA”). Specifically, FDA’s regulations at 21 C.F.R. §§ 203.3(u) and 203.50 will become effective on December 1, 2006. Although the regulations will become effective on December 1, the Agency announced that it intends to phase in its enforcement efforts by focusing the first year on products that are more susceptible to counterfeiting.

A. Background

Since publishing its final regulations in December 1999, the FDA has issued a series of stays to those provisions implementing the pedigree requirements of the PDMA. The last stay was announced in February 2004, when FDA again stayed the regulations, this time until December 1, 2006, in order to give industry time to focus its efforts on adopting mass serialization and RFID.

Under the PDMA, before each wholesale distribution, a “non-authorized distributor of record” (“non-ADR”) must provide a statement (that is, a pedigree) containing such information, as required by the FDA, identifying each prior sale, purchase, or trade of the drug, including the date of the transaction and the names and addresses of all parties to the transaction. 21 U.S.C. § 353(e)(1).

The statute defines an ADR as a wholesaler that has established an ongoing relationship with a manufacturer to distribute the manufacturer’s products. 21 U.S.C. § 353(e)(3)(A). The statute does not define “ongoing relationship.” Manufacturers and ADRs are not required to pass a pedigree. A manufacturer is, however, required to maintain a list of its ADRs.

FDA’s implementing regulations provide additional detail on the specific content of a pedigree. A pedigree must include:

• Name of drug
• Dosage
• Container size
• Number of containers
• Lot number
• Business name and address of all parties to each prior transaction, back to manufacturer
• Date of each previous transaction

21 C.F.R. § 203.50

Further, FDA’s regulations define an “ongoing relationship” between an ADR and a manufacturer as one in which the parties enter into a written agreement in which the ADR is authorized to distribute products for a period of time or a number of shipments. The written agreement must specify whether the ADR is authorized to distribute all or some of the manufacturer’s products. 21 C.F.R. § 203.3(u).

B. June 9, 2006 Announcement

On June 9, 2006, the FDA released its Counterfeit Drug Task Force Report. That report announced the FDA’s intention not to extend the stay on the pedigree regulations beyond December 1, 2006. The FDA explained that it was disappointed with pace of RFID adoption (although it continued to believe that RFID and mass serialization were keys to preventing counterfeiting) and that it no longer could justify delaying implementation of the pedigree regulations. Interestingly, the FDA noted that it did not believe that it had statutory authority to implement a universal and nationally uniform pedigree. Thus, from the FDA’s perspective, states may continue to enact their own pedigree requirements.

C. Draft Compliance Policy Guide

Finally, the FDA also issued a draft compliance policy guide (“CPG”) describing how the Agency intends to target its enforcement efforts under PDMA. The draft CPG, which is open for public comment until July 14, 2006 contemplates a phased-in approach to enforcement in order to allow wholesalers to focus their compliance activities on certain products during the first year of implementation of the pedigree regulation.

Although FDA reserves the right to initiate regulatory action and pursue criminal prosecution for violations involving any drug, first year enforcement will focus on drugs that are the most vulnerable to being counterfeited or diverted. FDA will not publish a list of such drugs; rather the Agency has set forth the following four factors it will consider in determining whether a drug is vulnerable to counterfeiting:

• High Value in the U.S. Market
• Prior Indicators (prior cases of counterfeiting)
• Reasonable Probability of Counterfeiting (for newly approved drugs)
• Other Violations of Law (FDA will enforce pedigree requirements against entities engaged in other activities that violate the law)

The Federal Register notice may be found at:
http://www.fda.gov/OHRMS/DOCKETS/98fr/06-5362.pdf

The FDA’s Counterfeit Drug Task Force Report may be found at:
http://www.fda.gov/oc/initiatives/counterfeit/report6_06.html

The draft CPG may be found at:
http://www.fda.gov/oc/initiatives/counterfeit/cpg.html

Brian Waldman
202-857-8971
waldman.brian@arentfox.com