Chairman Rick Scott and Ranking Member Kirsten Gillibrand will lead a Senate Aging Committee hearing on February 26 to examine the Food and Drug Administration’s regulatory processes and their impact on patient access to innovative therapies, especially for those with rare diseases. The session, titled “From Regulator to Roadblock: How FDA Bureaucracy Stifles Innovation,” aims to address how evolving FDA standards may delay safe and effective treatments.
The committee will hear from witnesses including Annie Kennedy of the EveryLife Foundation for Rare Diseases, Dr. Jeremy Schmahmann from Massachusetts General Hospital Ataxia Center, Bradley Campbell of Amicus Therapeutics, and Dr. Cara O’Neill of the Cure Sanfilippo Foundation.
This hearing follows a bipartisan letter sent in November 2025 to FDA Commissioner Dr. Martin Makary. In that letter, committee leaders expressed interest in understanding how the agency is supporting innovation in rare disease drug development and increasing approval speed.
“Members and expert witnesses will share the life-altering impacts of these delays on patients and their families,” according to the announcement. “The hearing will also explore opportunities to improve regulatory clarity and predictability, discuss how an efficient review process that puts patients first can strengthen U.S. biomedical leadership and ensure that lifesaving therapies reach patients faster.”
Chairman Scott and Ranking Member Gillibrand emphasized their commitment: “Chairman Scott and Ranking Member Gillibrand are committed to ensuring that the FDA fulfills its mission to protect patients while fostering innovation and maintaining America’s leadership in biomedical research.”
The public is invited to submit statements for the record by March 5, 2026.
The Senate Aging Committee addresses issues affecting older Americans such as Social Security, Medicare, long-term care, retirement security, fraud prevention resources like a hotline, oversight of federal programs nationwide—including elder abuse prevention—and maintains offices in both Dirksen (majority) and Hart (minority) Senate Office Buildings (official website). Rick Scott serves as chair while Kirsten Gillibrand is ranking member (official website).
