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Earlier today, Congress had a rare moment of harmony and passed the fifth authorization of the Prescription Drug User Fee Act, 96-1 in the Senate. This bill is part of the larger Food and Drug Administration Safety and Innovation Act, which is also currently being debated but expected to pass without much fuss.
Provisions of the PDUFA V include:
--Reauthorizes the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, which will help fast-track “breakthrough” drugs that treat life-threatening or serious diseases.
--Manufacturers of antibiotics would have an extended period of market exclusivity on new antimicrobials. It would also require the Government Accountability Office to look into the need for incentives in encouraging research and development of new antibiotics.
--Reauthorizes user fees for brand-name drugs and medical devices and introduces review fees for generic drugs and biosimilars. Sen. Tom Harkin (D-IA), one of the bill’s sponsors, expects the new fees to cut review times of generic drugs by a third and will speed availability to patients.
The FDA stands to collect billions in fees from the new user fee requirements: $4.1 billion in fees for review of brand-name prescription drugs and $1.6 billion for generic drugs, part of the $6.4 billion total from the bill. The authorization period is from FY 2013-FY 2017.
The bill will also put procedures in place to alleviate drug shortages, requiring manufacturers to notify the government of potential shortfalls and allowing the government to alleviate the situation by seeking out other sources.