Top Drug Regulator Richard Pazdur to Retire from FDA Amid Industry Concerns

Richard Pazdur filed papers to retire from the FDA at the end of December 2025, less than three weeks after accepting the role as director of the Center for Drug Evaluation and Research (CDER)123.

Pazdur's departure comes amid reported clashes with FDA Commissioner Marty Makary, including concerns about the legality and patient risk of expedited drug approval programs promoted by the new leadership2.

He is the fourth individual to lead CDER in 2025, raising concerns about regulatory instability and leadership turnover within the FDA24.

Pazdur is recognized for his 26 years of distinguished service, founding the Oncology Center of Excellence and contributing to cross-center regulatory innovation24.

Industry analysts and biotech investors reacted with concern, noting that Pazdur's exit represents a significant and unexpected disruption to FDA's regulatory leadership and could affect drug review progress2.

Sources:

1. https://www.statnews.com/2025/12/02/richard-pazdur-cder-director-fda-set-to-retire/

2. https://www.biospace.com/fda/pazdur-to-retire-weeks-after-taking-on-coveted-fda-role

3. https://aacrjournals.org/cdnews/news/2869/Top-Drug-Evaluator-to-Depart-FDA

4. https://www.bio.org/press-release/bio-statement-retirement-richard-pazdur-us-fda