FDA Human Medical Product User Fee Programs

The Food and Drug Administration (FDA) regulates human medical products to ensure they are safe and effective for their intended use in patients. Medical products include prescription and nonprescription drugs, biological products (“biologics”), and medical devices, among others. FDA regulation of these products involves implementation of premarket and postmarket requirements. Funding of FDA Medical Product Regulation To fund its regulatory activities, FDA relies on discretionary appropriations from two sources: (1) appropriations from the General Fund of the Treasury and (2) user fees paid by the regulated industry. Many user fee programs administered by FDA are permanently authorized, meaning they do not require reauthorization. Other user fee programs require reauthorization if they are to continue. The latter programs include those that help fund regulatory activities for prescription brand and generic drugs, medical devices, and biosimilar biological products (“biosimilars”). These four human medical product user fee programs have been reauthorized together in legislation on a five-year cycle. The authorizing legislation generally sets a total amount of fee revenue for the program’s first year, to be adjusted annually; specifies the fee types that FDA may collect; and requires that certain legal conditions be satisfied in order for FDA to collect and spend user fees. The original authorizing legislation for each of these four medical product user fee programs is as follows: The Prescription Drug User Fee Act of 1992 (PDUFA, P.L. 102-571). The Medical Device User Fee and Modernization Act of 2002 (MDUFMA, P.L. 107-250), or Medical Device User Fee Amendments (MDUFA). The Generic Drug User Fee Amendments of 2012 (GDUFA, Title III of the Food and Drug Administration Safety and Innovation Act [FDASIA], P.L. 112-144). The Biosimilar User Fee Act of 2012 (BsUFA, Title IV of FDASIA, P.L. 112-144). User Fee Reauthorization Due to the importance of user fees to FDA’s budget, reauthorization of the medical product user fee programs often has been considered to be “must pass” legislation. Congress generally uses such a reauthorization bill to address related FDA regulatory concerns. The most recent user fee legislation enacted in September 2022—the FDA User Fee Reauthorization Act of 2022, Division F, Continuing Appropriations and Ukraine Appropriations Act, 2023 (P.L. 117-180)—reauthorized each of the four medical product user fee programs through September 30, 2027. In exchange for paying user fees, industry receives from FDA a commitment to meet certain performance goals, such as completing premarket review within a specified timeframe. Prior to each five-year reauthorization cycle, FDA and industry negotiate the performance goals, which are finalized in a written agreement. The reauthorization process allows for input from relevant stakeholders and provides opportunity for public comment on the agreement. For the next reauthorization cycle, the Federal Food, Drug, and Cosmetic Act (FFDCA) requires the Health and Human Services (HHS) Secretary to submit the four user fee agreements to Congress by January 15, 2027. Scope of this Report This report (1) provides an overview of the framework that governs how FDA assesses and collects medical product user fees; (2) describes each of the user fee programs, including changes made by the most recent reauthorization legislation; and (3) illustrates the total costs of each user fee program, comparing the amounts derived from user fee and nonuser fee appropriations.