‘Trying to take me out’: Tidmarsh’s exit at FDA pushes an agency in transition toward turmoil

George Tidmarsh, head of the FDA's Center for Drug Evaluation and Research, resigned on November 2, 2025, effective immediately, following allegations that he used his regulatory position to inflict financial harm on former associate Kevin Tang13.

Tidmarsh was placed on administrative leave after Kevin Tang and Aurinia Pharmaceuticals filed a complaint and lawsuit against him, alleging a longstanding personal vendetta13.

Tidmarsh denies wrongdoing but confirmed learning about his administrative leave only after losing access to his agency email account1.

Before joining the FDA, Tidmarsh had extensive pharmaceutical industry experience, but no government background23.

His resignation follows a series of abrupt exits at the FDA, including Vinay Prasad, who led the Center for Biologics Evaluation and Research (CBER)23. Prasad’s leadership was marked by controversy and political criticism, especially following regulatory decisions around Sarepta’s Duchenne muscular dystrophy gene therapy25.

Tidmarsh suggested in interviews that Prasad played some role in his ouster, but did not elaborate3.

These leadership transitions have contributed to significant unrest and uncertainty among FDA staff, as well as broader commentary that FDA leadership is acting in more political and unconventional ways than in recent history45.

Staff have publicly expressed concerns about operational disruptions, toxic work culture, and a departure from traditional expert-driven review processes at the agency46.

Sources:

1. https://www.statnews.com/2025/11/02/fda-george-tidmarsh-regulator-kevin-tang/

2. https://www.biospace.com/policy/new-cder-head-tidmarsh-will-sub-in-at-biologics-group-after-prasads-exit

3. https://www.biospace.com/fda/fdas-tidmarsh-exits-amid-personal-conduct-probe

4. https://www.statnews.com/2025/08/08/fda-george-tidmarsh-vinay-prasad-staff-concerns/

5. https://www.pharmaceutical-technology.com/news/fda-leaders-are-acting-political-says-ex-agency-chief-counsel/

6. https://www.pharmtech.com/view/fda-abandoning-expert-reviews-implications-for-drug-developers-and-quality-professionals

Leave a Reply

Your email address will not be published. Required fields are marked *