FDA Issues Interpretation of Preliminary Injunction Barring Implementation of Drug Pedigree Law
The FDA's Addendum to FDA's Guidance for Industry: PDMA Pedigree Requirements -- Questions and Answers Related to the Preliminary Injunction Ordered 12/5/06 in RxUSA Wholesalers, Inc. v. HHS was posted today. The Addendum presents the FDA's interpretation of Judge Joanna Seybert's December 4, 2006 decision granting a preliminary injunction against implementation of a regulation promulgated under the Prescription Drug Manufacturing Act ("PDMA") that was designed to combat the distribution of counterfeit drugs. The regulation, 21 C.F.R. § 203.50, would require secondary drug distributors to provide their buyers with a pedigree including "the business name and address of all parties to each prior transaction involving the drug, starting with the manufacturer.” However, authorized distributors would be exempt from the pedigree requirement. Judge Seybert enjoined enforcement of the regulation on the ground that the plaintiffs were likely to succeed on their claim that
were the Rule were to go into effect while the exemption for authorized distributors existed, the result would completely defeat the purpose of the PDMA. Pedigree information would not be available for any drugs moving through commerce. Any drugs passing through an authorized distributor would contain no pedigree information due to the statute's exemption. Unauthorized distributors would be unable to comply with the Rule. They would be unable to provide complete pedigree information for all prior sales up to the manufacturer because - as the FDA has found - most drugs pass at least once through authorized distributors who do not provide pedigree information. And according to Plaintiffs, manufacturers refuse to sell products directly to Plaintiffs so they have no choice but to purchase from authorized distributors.
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But the Rule would essentially wipe out all the unauthorized distributors, leaving only authorized distributors who are exempt from the pedigree requirement. So none of the drugs ultimately going to the American consumer would contain pedigree information because the drugs would be provided solely through authorized distributors who are exempt from the pedigree requirement. Accordingly, the Court rejects Defendants' objections to the Magistrate's findings regarding Plaintiffs' likelihood of success on the merits.
While finding that the plaintiff's were likely to succeed on their challenge to the regulation, Judge Seybert emphasized "that Congress had a rational basis when it required unauthorized distributors to provide pedigree information for the drugs it distributed." Her opinion recognized that the "PDMA's pedigree requirement is important and necessary in light of Congress's findings that 'most of the drugs that were counterfeits, stolen, expired, or obtained through fraud were handled by secondary wholesalers, who were not authorized to distribute that manufacturer's product.' H.R. Rep. No. 100-76, at 17 (1987)," and that "PDMA's purpose 'is to protect American consumers from mislabeled, subpotent, adulterated, expired, or counterfeit pharmaceuticals, which are being dispensed under existing law and practice, and to restore competitive balance in the marketplace.' Id. at 6." She concluded, however, that the FDA's regulation would thwart, rather than advance, this purpose.
Judge Seybert's decision maintains the status quo pending the final outcome of the challenge to the regulation. For more information and commentary regarding this case, see Jayne Juvan's blog, Juvan's Health Law Update and Dr. Adam Fein's DrugChannels.
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