The BioCentury Show Ep. 92 - Reimagining FDA: Steve Usdin on Designing the Drug Regulator of the Future
Sep 6, 2025
In this engaging conversation, Steve Usdin, Washington Editor at BioCentury with over twenty years of experience in FDA reporting, explores the future of drug regulation. He discusses ideas for restructuring the FDA, including a dedicated agency model and independent oversight. Usdin highlights the Oncology Center of Excellence as a potential blueprint for innovation. He also advocates for learning-driven approaches to regulatory failures and new funding alternatives to restore public trust in the system.
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Create A Dedicated Medical Products Agency
- FDA would be better as a standalone medical products agency focused solely on drugs, biologics, and devices.
- Organizing centers around clinical areas (like Oncology Center of Excellence) would align regulation with patient needs and developer workflows.
Break Silos Between Modalities
- Separate drug, biologic, and device centers now blur technology and impede consistent review.
- Merging centers and shifting to clinical-area centers would reduce silos and reflect modern modalities like CAR-T.
Insulate Leadership With Fixed Terms
- Give the medical products regulator a fixed, multi-year commissioner term to insulate scientific decisions from short-term politics.
- Keep accountability to Congress for policy choices that reflect public values.