PDUFA reauthorization moves toward resolution

Faced with the possibility of a critical cutoff in funding for the Food and Drug Administration, Congress moved in late May to reauthorize the Prescription Drug User Fee Act that provides the bulk of the agency’s resources for new-drug review and approval. 


On May 24, the Senate voted 96-1 to approve the reauthorization and modification of the user fee program, with Vermont independent Sen. Bernie Sanders casting the sole dissenting vote with the assertion that it wouldn’t do enough to bring down drug prices. The House followed suit, overwhelmingly approving its own version of PDUFA legislation May 30.


Both versions include new provisions that would create, for the first time, a user fee program for generic drug makers. The generic industry would pay $299 million a year in user fees for the next five years — beginning Oct. 1, 2012 — for new FDA staff, faster generic approvals that could help clear a backlog of some 2,500 applications and more inspections of manufacturers’ production plants.


In another key change, the PDUFA proposals would create a user fee program for makers of biosimilar drugs. 


The House and Senate must still hammer out any differences in legislation. Some members of Congress predict that will happen before the July 4 recess.


Both the branded and generic drug industries hailed the moves in Congress. Ralph Neas, president and CEO of the Generic Pharmaceutical Association, said they’ll move Americans “one step closer to receiving faster access to … generic medicines.”


Said John Castellani, president and CEO of the Pharmaceutical Research and Manufacturers of America, “by casting a positive vote to reauthorize PDUFA, members of both the House and the Senate … have acted in the best interests of America’s patients.” The new funding, he added, also will “provide the FDA with the resources necessary to help build new scientific and regulatory capabilities … and promote ongoing biopharmaceutical innovation.”


One provision of the Senate’s version of PDUFA reauthorization, contained in the Food and Drug Administration Safety Innovation Act, did raise alarm bells among pharmacy groups, however. Five organizations — including the American Pharmacists Association, National Association of Chain Drug Stores and National Community Pharmacists Association — registered opposition to an amendment by Sen. Joe Manchin, D-W.Va.


Manchin’s proposal would make it tougher for patients to obtain common pain relief remedies containing hydrocodone by raising them from schedule III to the more restrictive schedule II classification. The change would “result in significant barriers for patients who have a legitimate need for these products, and it will result in adding to the nation’s healthcare costs with no assurance of a reduction in diversion and abuse,” the pharmacy groups warned.