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FDA Safety and Innovation Act is ready for final passage
The FDA Safety and Innovation Act of 2012, aka PDUFA V, has passed through conference, to await a full Congressional vote, and the President’s signature, to become law. The key parts—reauthorization of user fees for drugs and medical devices, and new user fees for generic drugs and, eventually, biosimilars, are intact. Missing, however, is the language tentatively accepted by the US Senate, but withdrawn from the final bill, to set up a federal pedigree/track-and-trace system for drug shipments. The version that the Senate had contemplated, based on a “discussion draft” generated by the Pharmaceutical Distribution Security Alliance called the RxTec Act, would have required serialization at the individual unit level of drug packages, but to track them only at the lot level. Absent a federal rule, the way is now clear toward implementation of California’s 2008 electronic-pedigree rules, which are set to go into force beginning in 2015. (By California’s own legislation, any federal pedigree program would have pre-empted its effort.)
“The broad coalition of stakeholders in PDSA supported the committees’ process and believes the discussion draft of June 15th merited support and inclusion within the user fee legislation with only limited modifications,” says a statement issued by the Alliance. “PDSA is disappointed these protections have not been included as part of the PDUFA bill; however, we remain hopeful all parties will continue to work — right now – on this historic effort to protect America’s patients.”
HDMA, a member of the Alliance, issued its own statement-- "Healthcare distributors, along with other stakeholders, worked very hard over the last six months to reach consensus on a workable, uniform federal pedigree system. Such a system would have streamlined the current patchwork of state laws and regulations and enhanced the safety and security of the supply chain to the benefit of all patients," said HDMA president John Gray.
Because the RxTec Act was talked about as a “California pedigree killer,” and because FDA was reluctant to voice support for it in the version included in the Senate bill, it’s not clear that its removal is a case of business triumphing over government regulators. Many pharma manufacturers, especially multinational ones, have serialization projects already in place, although there is an enormous number of packaging lines that will have to be upgraded between now and 2015 if industry is serious about meeting the 2015 deadline. At the same time, serialization and anti-counterfeiting plans are moving forward in Europe and other parts of the world. Will the spate of counterfeit products entering legitimate supply chains that occurred in the US even during the deliberations for RxTec continue? Watchful waiting appears to be the main industry position.