FDA Proposed Rule Would Eliminate Certain Drug Pedigree Requirements
This post was written by Erin A. Janssen and Areta L. Kupchyk.
On July 14, 2011, the Food and Drug Administration (FDA) published a proposed rule to remove a section of the Prescription Drug Marketing Act (PDMA) regulations to permit wholesale distributors to document the chain of custody (also known as the "pedigree") of prescription drug products only back to the last "authorized distributor" instead of all the way back to the manufacturer. The PDMA requirements as currently written require that prior to the completion of any wholesale distribution of a prescription drug, an unauthorized distributor must provide to the purchaser “a statement identifying each prior sale, purchase, or trade of such drug,” starting with the manufacturer, and that the identifying statement (i.e., “pedigree”) must include certain information about the drug and each prior sale, purchase, or trade. FDA indicated that this action is being taken in response to longstanding issues, including an injunction currently in effect handed down by the District Court for the Eastern District of New York, regarding the application of and compliance with this requirement. FDA also announced in the proposed rule that it intends to exercise enforcement discretion while the rulemaking is pending as long as the pedigree identifies the names and addresses of the last authorized distributor of record that handled the drug and the associated dates of transactions involving that last authorized distributor of record and the drug, as well as the names and addresses of all subsequent unauthorized distributors that handled the drug and the corresponding dates of those transactions. Comments on the proposed rule are due to the agency on or before September 12, 2011.
