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Under the continuing program passed Wednesday, the FDA would collect $6.4 billion in fees from companies over the next five years, starting in 2013. About $1.8 billion, or nearly 30 percent, would come from new fees, including the first ever paid by generic drugmakers. Whereas most new drugs are reviewed in 10 months, the typical review for a generic drug takes over 30 months. The FDA has a backlog of more than 2,700 generic drug applications awaiting review, according to the Generic Pharmaceutical Association. The fees from generic drugmakers are expected allow the agency to hire 800 new staffers. By the end of 2017, the FDA is expected to have eliminated the drug backlog and reduced review times to an average of 10 months. The legislation also renews established user-fee programs for traditional drugmakers and medical-device companies. Companies succeeded in adding a number of provisions to the bill designed to make reviews faster and more predictable. The bill allows the FDA to speed up the approval of drugs that appear to have breakthrough potential by relaxing certain requirements. The agency would be able to accept smaller, shorter clinical studies when reviewing first-of-a-kind medicines for life-threatening diseases.
A provision supported by medical-device manufacturers requires that the FDA provide a rationale for denying approval of medical implants within 30 days of issuing a rejection. Medical-device lobbyists have complained that the FDA has become overly cautious when reviewing routine medical devices.
[Associated
Press;
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