Key question: How will the FDA play the new California 2015 timeline (assuming Governor Schwarzenegger signs the bill)? Will the FDA:
- Implement national serialized e-pedigree in sync with a new
- Embark on a national effort that would preempt the California law prior to 2015?
- Do nothing and hope everything turns out OK?
Pharmacists Keep Federal Track-And-Trace in the Clubhouse
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. I applauded this bill when it was introduced in April, although the bill has only garnered 11 co-sponsors and has no Senate counterpart.
H.R. 5839 was going to be incorporated into other related FDA legislation, but intense behind-the scenes lobbying against the bill has now killed that option. Paul Kelly, NACDS vice president of government affairs, recently boasted: “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.” (source)
As you may recall, NACDS sponsored and promoted questionable calculations from sometimes track-and-trace advocates Accenture. Unfortunately, my dissection of Accenture’s study probably cost me the chance to have lunch with spokesgolfer Tiger Woods. Oh well.
In the meantime, Federal progress will likely be slow without (a) a new push by the FDA, and/or (b) a compelling trigger event, such as counterfeit drugs discovered in a retail pharmacy.
FDA Still not on Back Nine of PDMA
Meanwhile, 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 PDMA requires, among other things, that secondary wholesalers provide a pedigree prior to each wholesale distribution of prescription drugs. The requirement to pass a pedigree applies to those wholesalers who are not authorized distributors of record (ADRs) for the prescription drugs that they distribute.
In July, the U.S. District Court for the Eastern District of New York “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. So, no PDMA pedigree, either.
FDA in the Rough
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 – see the links in The FDA and EC Dive into Supply Chain Security.
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.
And among the three options listed at the top of this post, I'm voting for Option 1 but fear we may end up with option 3.