Earlier this month, the FDA gave its recommendations to Congress for the next reauthorization of the Prescription Drug User Fee program. In order to support these changes, the FDA recommends that the annual user fee collections be increased $87.4 million to $392.8 million. The Prescription Drug User Fee Act (PDUFA) of November 1992 first authorized the user fee, which is garnered from the pharmaceutical industry and is reauthorized by Congress every five years. From the recommended increase, $29.3 million would support FDA efforts to ensure the safety of drugs after they have come to market, including the development of new approaches to detect and prevent potential health threats. A total of $49.4 million would fund $17.7 million to compensate for inflation and employee benefits and salary increases, $11.7 million in facility costs and $20 million to make up for increases in the FDA’s drug review workload.

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