Issue Date: May 21, 2012
Congress is working to combine multiple actions related to drugs into a single bill. First, the legislation aims to authorize the Food & Drug Administration to collect user fees from the drug and medical device industry for five years. Second, it includes several regulatory reform measures related to drug safety and development.
The House of Representatives and Senate are expected to vote on the package this month with the goal of sending a compromise measure to the President by the end of June. Current user fee programs expire Sept. 30. The following are highlights of the pending legislation:
The bill reauthorizes
◾ The Prescription Drug User Fee Act (PDUFA), under which industry will pay $713 million in fiscal 2013; higher amounts will be incurred in the remaining four years.
◾ The Medical Device User Fee & Modernization Act, under which industry pays $595 million over five years.
◾ The Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, which provide incentives for studies on the effects of prescription drugs and medical devices on children.
The bill establishes
◾ The Generic Drug User Fee Act, under which industry pays $1.5 billion over five years in return for faster and more predictable review of generic drug applications and increased inspections of drug facilities.
◾ The Biosimilars User Fee Act, which includes four types of fees for biosimilar products: application, product, establishment, and product development. The first three would be set equal to the PDUFA rate for each type of fee, and the product development fee would be set at 10% of the PDUFA application fee.
The bill reforms
◾ Conflict-of-interest rules at FDA by loosening them to ensure that the most knowledgeable experts can serve on FDA’s scientific advisory committees.
◾ The drug approval pathway by increasing access to the accelerated pathway, particularly for drugs that treat rare diseases; by providing incentives for developing antibiotics; and by addressing increased globalization of drug manufacturing.
◾ Reporting requirements for disruptions in production of lifesaving drugs and modifies the process to expedite approval of drugs in short supply.
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