This event was Part IV of the Alliance’s Health Policy Roundup and 2022 Forecast series. View all events in this series here.
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Since the passage of the first User Fee Act in 1992, user fee programs have helped finance the Food and Drug Administration (FDA)’s review of human medical products such as drugs and medical devices. By authorizing the collection of user fees from biopharmaceutical companies, the FDA can support increased staffing and resource capacity building, as well as generate regulatory predictability. This predictability, in turn, is meant to help incentivize industry investment in clinical research and development. During the pandemic, user fees have also helped enable the FDA to provide prompt recommendations and regulatory guidance for COVID-19 vaccines and therapeutic development. The User Fee Act is subject to renewal every five years, with the next renewal slated for 2022, and involves careful negotiation among manufacturers, the FDA, and Congress. The latest reauthorization is a must-pass piece of legislation for Congress in 2022.
This event will explain user fee programs and their role within the drug development and FDA regulatory review process. Panelists will provide insights on the stakeholders, timeline, the process of reauthorization, the history of these bills being used for broader health legislative initiatives, and explore lessons learned from almost thirty years of user fee programs as we approach our next iteration.
For additional information on the U.S. Food and Drug Administration review process, see Chapter 4 of the Alliance’s Health Policy Handbook.
- Anna Abram, Senior Advisor, Akin Gump Strauss Hauer & Feld LLP
- Jeremy Sharp, Managing Director, Waxman Strategies
- John Stone, J.D., Principal, BGR Group
- Emilia DiSanto, J.D., Executive Vice President, Venn Strategies (moderator)
This event was made possible with support from Arnold Ventures.