Progress on Federal Pedigree Will be Slow

Implications: Representatives Steve Buyer (R-IN), Gene Green (D-TX), Jim Matheson (D-UT), and Mike Rogers (R-MI) co-sponsored H.R. 5839 Safeguarding America’s Pharmaceuticals Act of 2008. H.R. 5839 was going to be incorporated into other related FDA legislation, but intense behind-the scenes lobbying by the pharmacy industry against the bill has now stopped that option. However, I believe that it would be best for the FDA to implement national serialized e-pedigree in sync with a new California timeline. Although the FDA has not decided on its next step, I presume that nothing will happen until after the Presidential election and a possible new FDA commissioner.

Analysis: As I point out CA E-Pedigree Delayed to 2015 (Council Site), the California serialized e-pedigree law will likely be delayed until 2015. Unfortunately, the federal situation will not provide a quick solution, leaving us with the prospect of managing our crazy patchwork of inconsistent state laws regarding drug distribution for the next few years.

Paul Kelly, NACDS vice president of government affairs, is quoted as saying: “We remain very pleased that Chairman Dingell has decided not to include an electronic pedigree requirement, and more importantly the track-and-trace requirement, in that bill.”

The Food and Drug Administration Amendments Act of 2007 requires the FDA to establish technology standards for the pharmaceutical supply chain by 2010. The FDA requested comments and information earlier this year. 

However, the FDA remains stymied in its attempts to implement the pedigree regulations of the Prescription Drug Marketing Act (PDMA) following a December 2006 injunction. The U.S. District Court for the Eastern District of New York recently “affirmed” the preliminary injunction against the FDA in the case of RxUSA Wholesale, Inc. v. Department of Health and Human Services (HHS). See the FDA’s Backgrounder re: RxUSA Wholesalers, Inc. v. HHS for more details.