Congress will have its hands full with prescription drug legislation this year as it works to reauthorize the 20-year-old Prescription Drug User Fee Act (PDUFA) and to establish, for the first lime, two new user-fee programs at the FDA-one for generic drugs and the other for generic biologies. One giant bill will probably cover all three programs. At hearings on February 1, House committee members said they were hoping that they could pass a "skinny" bill-one without lots of amendments by June. We'll see. The establishment of a new Generic Drug User Fee Act (GDUFA) may be the most important part of the legislative trifecta. The FDA and the generic drug industry agreed on a plan that would require generic marketers and producers of the commodity chemicals that go into finished products to pay fees amounting to about $300 million per year. In return, the FDA would commit to reducing the backlog of Abbreviated New Drug Applications (ANDAs) and would speed up review times for new ANDAs.
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