SummaryUser fees are increasingly central to the funding of the drug and device review programs, and in some cases these fees account for a larger proportion of the Food and Drug Administration's (FDA) budget than congressionally-appropriated monies. For example, user fees account for 68 percent of the FDA's review budget for prescription drugs, while 58 percent of the review budget for generic drugs comes from user fees.
Additionally, both user fee programs for prescription and generic drugs have large carryover balances of unspent user fees close to $300 million. This is likely troubling for generic drug sponsors who are still waiting for significant regulatory improvements to the product review process. Industry and the FDA are expected to refine more established user fee programs; however, recently enacted programs (e.g., generic drugs) may require greater modification to ensure that the FDA is able to meet industry expectations.
Under the FDA’s user fee programs, industry commits to paying fees to the FDA to improve the timeliness and efficiency of medical product reviews. Industry and the FDA engage in negotiations that define the parameters of forthcoming user fee programs, and then they provide their recommendations to Congress. Congress reviews these recommendations and augments proposed programs to align with congressional priorities before providing a five-year reauthorization for the FDA’s user fee programs. With reauthorization negotiations underway for each of the four human medical product user fee programs – Prescription Drug User Fee Act (PDUFA), Biosimilar User Fee Act (BsUFA), Medical Device User Fee Act (MDUFA), and Generic Drug User Fee Act (GDUFA) -the FDA and industry are evaluating past successes and areas for improvement with an eye toward strengthening each program. While individual programs have unique objectives and goals, several metrics are common across these programs and provide insight into the FDA’s progress toward enhancing regulatory processes.
The table, which highlights some metrics and elements from each of the above-mentioned user fee programs, is available here.
produces measurable results. Let's work together.