I've been skeptical about the injunction filed by a group of secondary wholesalers to stop implementation of the pedigree requirements of the PDMA on Dec. 1. (See The FDA on PDMA and Channel Conflict as Pedigree Looms.)
But on Thursday, Magistrate Judge Kathleen Tomlinson recommended that a preliminary injunction against the Department of Health and Human Services and the FDA be granted. See the Wall Street Journal story Judge Rules on Long-Delayed Drug Law. (Fans of legal reasoning will surely enjoy the full injunction report and recommendation.)
I won't presume to evaluate the legal reasoning here, but will simply note two claims that the magistrate used in making her judgment:
- "Plaintiff RxUSA Wholesale’s President, Robert Drucker, states that he has attempted for several years to obtain authorized distributor status for his company from virtually every major manufacturer of pharmaceuticals in the United States, to no avail." (page 18)
- "...none of the “big three” authorized distributors ... will agree to provide any pedigree information as far back as the manufacturer from whom they purchased drugs." (page 18, footnote 4)
Supply Chain Impacts
I've been critical of the FDA's analysis of the pharmaceutical supply chain, such as my comments in June when PDMA implementation data was announced. (See FDA blind to the supply chain’s evolution.) Nevertheless, the fall-out from this injunction could be much bigger than the specific legal issues in the case.
Speculatively, I wonder how this new wrinkle in the implementation of pedigree will affect the reimportation debate (See Of Spammers and Senators.) Apparently, the FDA's unwillingness to allow reimportation has been a factor delaying Dr. von Eschenbach's nomination.
The already-high risks of reimportation rise astronomically without a pedigree system. Unfortunately, we may default back to a patchwork of state-level pedigree regulations, which would be a boon to clever counterfeiters.
This injunction should also make drug manufacturers pay extra attention to the movement of their products through the supply chain to pharmacies. Previously obscure activities like "analyzing EDI 867 data" should now be a mandatory part of secure business practices.
I'll update this post if needed after the final decision on Friday.