Vinay Prasad Departs FDA Amid Conservative Criticism and Sarepta Gene Therapy Controversy
Vinay Prasad resigned from his position as director of the FDA's Center for Biologics Evaluation and Research (CBER) and chief medical and scientific officer after less than three months at the agency124.
His exit comes amid controversy over FDA decisions involving Sarepta Therapeutics' Duchenne muscular dystrophy gene therapy, Elevidy1235.
Prasad's tenure became a focal point of heightened scrutiny and conservative criticism, especially regarding recent drug approval decisions and safety concerns35.
Official statements cited a desire not to be a distraction and to spend more time with family as reasons for his departure12.
Prasad, appointed in early May 2025, was previously known for his critical stance on pandemic response and vaccine policy in prior public statements2.
Sources:
1. https://www.statnews.com/2025/07/29/vinay-prasad-exits-fda-marty-makary-cber-director-chief-medical-scientific-officer/
2. https://economictimes.com/news/international/global-trends/us-news-dr-vinay-prasads-fda-exit-in-less-than-3-months-linked-to-sarepta-gene-therapy-controversy-check-details/articleshow/122996160.cms
3. https://www.fiercepharma.com/pharma/vinay-prasad-departs-fda-amid-conservative-criticism-controversy-over-sarepta-gene-therapy
4. https://firstwordpharma.com/story/5984819
5. https://www.pharmexec.com/view/vinay-prasad-fda-departure-controversy-drug-rejections