Name: #414: How the Upcoming FDA User Fee Legislation Could Advance Innovation and Reshape the Agency
Start: 2026-06-15T11:00:00-0400
End: 2026-06-15T12:15:00-0400

#414: How the Upcoming FDA User Fee Legislation Could Advance Innovation and Reshape the Agency

Monday June 15, 2026 11:00am - 12:15pm EDT

115AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-521-L04-P; CME 1.25; RN 1.25

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 Objectives

Describe the user-fee reauthorization timeline and how Congressional “adds” can modify negotiated performance goals; Examine 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.

Chair

Jeffrey Francer, JD, MPA

Speaker

How the Upcoming FDA User Fee Legislation Could Advance Innovation and Reshape the Agency
Clare Paoletta

How the Upcoming FDA User Fee Legislation Could Advance Innovation and Reshape the Agency
Barrett Tenbarge, JD

Speakers

Jeffrey Francer

Vice President, Head of International Regulatory Affairs and Global Policy, Eli Lilly and Company, United States

Jeff Francer serves as Vice President, Head of International Regulatory Affairs and Global Regulatory Policy for Eli Lilly and Company. In this role, Jeff leads Lilly’s interactions with regulators and submissions in the Asia-Pacific, Europe, Middle East, and Africa regions. Jeff... Read More →

Clare Paoletta

Professional Staff Member, US House Committee on Energy and Commerce, United States

Barrett Tenbarge

Partner, Faegre Drinker, United States

Monday June 15, 2026 11:00am - 12:15pm EDT
115AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Forum | 06: ProfDevelop-Program-PortfolioMgmt, Forum

Audience Intermediate
Area Student and Early Career Pathway
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Regulatory,Project Management & Strategic Planning
Feature Topics Student and Early Career Pathway
Tags Forum

Success you have shared X tickets.

DIA 2026 Global Annual Meeting

Jeffrey Francer

Clare Paoletta

Barrett Tenbarge

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Success you have shared X tickets.

DIA 2026 Global Annual Meeting

Jeffrey Francer

Clare Paoletta

Barrett Tenbarge

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