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BGOV Bill Summary: H.R. 7667, FDA User Fee Reauthorization

June 6, 2022, 9:33 AM

Food and Drug Administration fees for drugs and medical products would be extended for five years under a modified version of H.R. 7667.

The bill would reauthorize user fees for prescription drugs, medical devices, generic drugs, and biosimilar products from fiscal 2023 through 2027. The current authorization is set to expire Sept. 30.

The FDA negotiates user fees and performance goals with industry and submits its recommendations to Congress for reauthorization on a five-year cycle.

The agency separately receives an appropriation from Congress annually. The user fees are intended to supplement that appropriation, and current law prevents collection of ...