News Brief: President Bush signs reauthorization of PDUFA
News Brief: President Bush signs reauthorization of PDUFA
President Bush authorized the third five-year extension of the Prescription Drug User Fee Act (PDUFA) of 1992 on June 11. The reauthorization of PDUFA was included in bioterrorism legislation.
The law maintains the performance goals of PDUFA II, which included reduced drug review times and increased and accelerated consultations between the Food and Drug Administration (FDA) and product sponsors. In addition, PDUFA III meets two FDA goals by remedying resource shortages that have affected the program in recent years.
The law authorizes the agency to collect $1.2 billion in user fees over the next five years. This will enable the FDA to increase the staffing of the drug program by 450 full-time employees. The law also includes authorization to spend $70 million of the user fees to increase the agency’s surveillance of the safety of drugs during the first two (or, for potentially dangerous medications, three) years on the market. It is during this initial period, when new medicines enter wide use, that the agency is best able to identify and counter adverse side effects that did not appear during the clinical trials.
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