Juvan's Health Law Recap--April 22, 2007: Drug Pedigree Developments
The FDA has continued to aggressively fight the injunction issued by the District Court for the Eastern District of New York in Rx USA Wholesale v. Department of Health and Human Services, Food and Drug Administration. The injunction issued in the case prohibits the FDA from requiring that secondary wholesale distributors of pharmaceuticals pass a pedigree that tracks each prior sale of a drug, a requirement that secondary wholesalers claim is impossible given that the statute and accompanying regulation do not impose a concomitant obligation on authorized distributors, or those distributors that have entered into an agreement with the manufacturers.
The FDA has appealed the lower court's ruling and most recently filed a brief urging the Second Circuit Court of Appeals to overturn the injunction. The brief argues that (1) congressional intent is clear on the face of the statute that drug pedigrees must track the chain of custody back to the manufacturer, (2) the statute and regulations comport with the protections in the equal protection and due process clauses, as they are rationally related to Congress's desire to curtail pharmaceutical counterfeiting and consistent with Congress's findings that "non-authorized distributors were the avenue through which most diverted drugs entered the retail market and created public health dangers," and (3) the scope of the preliminary injunction is far too broad because it prohibits the FDA from requiring that drug pedigrees include the information set forth in subsections (1) through (5) of the regulation. In the brief, the FDA states with respect to the latter argument that "Plaintiffs have not, and cannot, claim that it is impossible for them to supply this additional information, as it is readily apparent on the face of the drugs' labeling."
With the hold on the federal drug pedigree regulations requiring secondary distributors to trace the chain of custody back to the manufacturer currently in place, the focus has shifted to the states. Last week, I received a call from an individual from the Texas legislature informing me of progress of the Texas drug pedigree legislation. For those who are interested in tracking the legislation on a state by state basis, you can follow the developments of the proposed Texas law on the state legislature web site.
