December 2006               return to newsletter contents page

District Court Delays Enforcement of PDMA Regulations

On December 8, 2006, the Federal District Court for the Eastern District of New York entered an order granting a preliminary injunction enjoining the Food and Drug Administration from implementing 21 C.F.R. §203.50(a) which required that unauthorized wholesale distributors provide pedigree information for sales all the way back to the manufacturer.

The suit was filed by seven unauthorized wholesale distributors who argued that they would be irreparably harmed if the regulation was implemented because the Prescription Drug Marketing Act (“PDMA”) does not require either manufacturers or their authorized distributors of record (“ADR”) to pass along pedigree information to such purchasers.

In granting the preliminary injunction, the Court stated that the neither the statute as originally enacted or as amended specifically or expressly required unauthorized distributors to provide pedigree information all the way back to the manufacturer. However, in 1994 the FDA proposed a new rule requiring the unauthorized wholesale distributors to provide pedigree information for sales all the way back to the manufacturer. Thus, the Court said, “If 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.”

Issuance of the Injunction Not a Final Determination

The purpose for the issuance of an injunction is to maintain the status quo while the court hears the merits of this case. The Court and the Parties will now move forward
with the process to determine the facts of the case, hear evidence, and other procedures. The Defendants are scheduled to file their answer to the complaint on December 20, 2006 (unless extended).