The Senate Special Committee on Aging will hold a hearing on February 26, 2026, to discuss the regulatory processes of the Food and Drug Administration (FDA) and their impact on patient access to therapies, especially for those with rare diseases. The hearing, titled “From Regulator to Roadblock: How FDA Bureaucracy Stifles Innovation,” is set to examine how evolving FDA standards may delay safe and effective treatments.
Committee Chair Rick Scott and Ranking Member Kirsten Gillibrand will lead the session. According to the committee’s announcement, "Members and expert witnesses will share the life-altering impacts of these delays on patients and their families. 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."
This event follows a bipartisan letter sent in November 2025 to FDA Commissioner Dr. Martin Makary. The letter sought information about how the agency supports innovation in drug development for rare diseases and works to increase both the speed and number of approvals for such conditions. Scott and Gillibrand stated they are "committed to ensuring that the FDA fulfills its mission of protecting patients while fostering innovation and maintaining U.S. leadership in biomedical research."
Witnesses scheduled include Annie Kennedy from the EveryLife Foundation for Rare Diseases; Dr. Jeremy Schmahmann from Massachusetts General Hospital; Bradley Campbell, CEO of Amicus Therapeutics; and Dr. Cara O’Neill from Cure Sanfilippo Foundation.
The hearing will take place at 9:30 a.m. ET in room SH-216 of the Hart Senate Office Building, where the minority office of the Senate Aging Committee is located. The committee focuses on issues affecting older Americans—including Social Security, Medicare, long-term care, retirement security—and oversees related federal programs nationwide (source). It also provides resources like a fraud hotline to protect older adults from financial exploitation (source).
Scott serves as chair while Gillibrand is ranking member (source). Written statements from members of the public or organizations are invited by email before March 5 at 5:00 p.m., provided they do not contain personal identifying information.
The hearing will be streamed live online.
