FDA User Fee Act Reauthorizations

The reauthorization process for the Prescription Drug User Fee Act (PDUFA), Generic Drug User Fee Act (GDUFA), Biologic Drugs User Fee Act (BDUFA) and Medical Device User Fee Act (MDUFA) is underway. These run on a 5-year cycle and require Congressional enactment that authorizes the Food and Drug Administration (FDA) to collect user fees from biopharmaceutical and medical device companies to supplement its funding and review and approve innovative products faster and more efficiently.

The reauthorization process begins with negotiations between FDA, industry, and Congress. Once a proposal is negotiated that includes the terms and conditions related to setting user fee rates and performance metrics, it must have been submitted to Congress by January 15, 2022. Then Congress must pass reauthorization before expiration of the current UFA by September 30, 2022, or the FDA will have to cut staff and forestall product reviews.

This is the sixth reauthorization of PDUFA and its proposal was submitted to Congress on January 12, 2022. For more details on PDUFAVII go here.

MichBio, joined a handful of other state bio associations, in co-sponsoring a Congressional briefing for staffers to learn more about why it is critical for Congress to pass the PDUFAVII reauthorization proposal. Committee hearings have begun to review the proposal and move it through the legislative process, with the hope that Congress will be able to vote on it by June or July.

As for MDUFA, the process has moved at a very slow rate, and a negotiated proposal has not been submitted to date. Discussions between the FDA and medtech industry are ongoing but few details have emerged; there are wide differences in a number of areas. It’s likely that a proposal will not get to Congress until at least April or beyond, so the path for MDUFA approval is fraught with some risk.