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How the Upcoming FDA User Fee Legislation Could Advance Innovation and Reshape the Agency
Session Chair(s)
Jeffrey Francer, JD, MPA
Vice President, Head of International Regulatory Affairs and Global Regulatory P
Eli Lilly and Company, United States
As FDA–industry negotiators finalize future performance goals, Congress will shape the next user-fee statute. This session examines how budget politics, workforce shifts, and innovation priorities—from AI to MAHA—may reshape FDA’s mandate.
Learning Objective : Understand the user-fee reauthorization timeline and how Congressional “adds” can modify negotiated performance goals; Analyze how budget pressures and recent reductions in force may affect FDA capacity and review predictability; Assess how leadership priorities to accelerate innovation—including review vouchers, AI, and MAHA initiatives—could influence policy riders and oversight.
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