Pressure intensifies in behind-the-scenes negotiating on federal pedigree/track-and-trace rules

Congress looks to a July passage of the Prescription Drug User Fee Act—with or without drug-tracking and wholesaler regulation

Because a “gag order” is in place among the parties negotiating, in industry meetings and with Congressional committee staffs, according to the Washington-insider website Politico.com, there isn’t a day-by-day summation of how the negotiations are going. But there is a general push to have the vital Prescription Drug User Fee Act (PDUFA), which is up for renewal, out of committee by the end of June. And the effort to attach track-and-trace rules (generally summed up as the Billbray-Matheson bill, H.R. 3026) might come to naught, because there is still a less-than unified stand from the full range of parties involved in pharma distribution, from manufacturers to wholesalers to pharmacies.

Politico.com reported on May 17 that although negotiations are making progress, “certain industry stakeholders were still working through key differences.” There have been many steps to get to this point: in January, a group called the Pharmaceutical Distribution Security Alliance (which includes PhRMA, HDMA, GPhA and specific manufacturers, wholesalers and retailers) offered what was called the “RxTEC Act,” which provides for serializing drugs at the unit level and federal wholesaler licensing rules, but which does not require the ability to track drugs at the unit level through distribution. FDA representatives are on record as opposing the lack of traceability. A letter from the California Board of Pharmacy, sent to Rep. Brian Billbray, stated that “this proposal would pre-empt the California pedigree requirements, and replace them with less robust and ultimately less purposeful federal infrastructure.” Specific concerns include the lack of traceability at the unit level, and the delay in implementation to 2020 (California currently has a 2015 deadline to begin implementation within the state).

Ironically, one set of players sometimes looked on as the source of black-market drug trading--secondary wholesalers--are for tighter regulation. The National Council of Pharmaceutical Distributors (NCPD; Miami) sent its own letter to the Senate Health, Environment and Labor Committee, stating that "NCPD would prefer to see a more definitive pathway and binding language that would provide ... traceability." Many NCPD members have already installed drug-pedigree and tracking technology.

Given the spate of counterfeit drugs that has recently occurred, some legislators have new enthusiasm for getting a law passed to tighten pharma supply chain security. And many industry players are looking at the federal bill as a way to forestall the Calfornia law (which has been postponed repeatedly since first proposed in the mid-2000s); if there is no federal law, then the California rules have a good chance of going into effect.

PDUFA is an essential law for funding FDA drug-approval activities; if it is not passed before Oct. 1, FDA runs out of money. Other pieces of legislation, including rules on abating drug shortages and funding rare disease research are additional potential add-ons. And while a federal pedigree/track-and-trace law could always be considered as its own piece of legislation, proponents of RxTEC fear that if it is not attached to PDUFA, the urgency for passing it will slip away altogether.