US Court Delays FDA Drug-Pedigree Requirements
Other pedigree requirements remain in effect, FDA says, and wholesalers can comply by providing a pedigree that tracks the drug to initial sale by an authorized distributor. Though the injunction strictly applies only to the Eastern District of New York, to avoid the chaos that would follow a regional patchwork of requirements, FDA indicated that it will apply the Eastern District standard throughout its jurisdiction (1).
The lawsuit was filed Sept. 20 by online discount outlet RxUSA Wholesale, Inc. (Port Washington, NY, http://www.rxusa.com/) and six other regional secondary wholesale operations. The suit claims that contradictions in the Prescription Drug Marketing Act (as modified by the Prescription Drug Amendments of 1992) made it effectively impossible for wholesalers to comply with the law or the regulations derived from it. Essentially, the law and the regulation required secondary wholesalers to obtain and pass on pedigrees stretching back to the original manufacturer, but did not require authorized distributors (from whom the secondary market buys its products) to provide pedigrees linking the lots back to the manufacturer.
In issuing the injunction, Judge Seybert confirmed a Magistrate Judge's "Recommendation and Report," which held that implementing the rules as they were due to go into effect Dec. 1 would have destroyed the plaintiffs' business. Thus, FDA is barred from enforcing the rules until the suit is tried and decided.
1. US Food and Drug Administration, Guidance for Industry: Prescription Drug Marketing Act (PDMA) Requirements, (FDA, Rockville, MD, 2006), http:// http://www.fda.gov/CDER/regulatory/PDMA/PDMA_qa.pdf, accessed Jan. 17, 2007.