Category: Drug & Biotech Policy
Written By: Pharmacally Medical News Desk
When Dr. Vinay Prasad left the FDA’s Center for Biologics Evaluation and Research (CBER) at the end of July, it reminded me the incidence when MIT scientist Dr. V.A. Shiva Ayyadurai suddenly left CSIR-Tech in India. Both exits were quick, unexpected and politically driven. But in Dr.Prasad’s case, there was a twist just two weeks later, he was back. Here’s what happened and why it matters for drug regulation.
Late July (July 30, 2025): Dr.Prasad’s suddenly steps down from CBER after only a few months in the role. U.S. Department of Health and Human Services (HHS) said he “did not want to be a distraction,” adding he planned to return to California to be with his family. After that George Tidmarsh was appointed acting director.
Dr. Vinay Prasad stepped down from the FDA in July 2025 after old comments about Donald Trump came back into focus. Years earlier, during Trump’s first term, he had joked on a podcast about putting pins in a Trump voodoo doll and said he wanted Joe Biden to win in 2020. Activist Laura Loomer resurfaced those remarks and called him a “progressive saboteur.”
The controversy landed at a moment when Prasad was already under fire for pausing, then quickly resuming, FDA review of Sarepta Therapeutics’ gene therapy Elevidys after safety concerns were raised. That decision had split patient groups, industry, and policymakers, painting him as both too cautious and too compassionate. The mix of political attacks and heightened scrutiny over Elevidys created an environment that made his position shaky, leading to his brief resignation before internal FDA and HHS support brought him back weeks later.
Early August (around August 9–11, 2025): In early August 2025, just a couple of weeks after leaving the FDA’s Center for Biologics Evaluation and Research (CBER), Dr. Vinay Prasad were asked to return. The U.S. Department of Health and Human Services (HHS) confirmed that this was not just a casual comeback but a formal request from the FDA itself. Their statement was: “At the FDA’s request, Dr. Vinay Prasad is resuming leadership of the Center for Biologics Evaluation and Research.”
Political tug-of-war
Dr. Prasad’s return wasn’t just about his scientific role; it was also tied to political strategic actions.
After he resigned in late July 2025, there was strong internal backing for him from FDA Commissioner Marty Makary and HHS Secretary Robert F. Kennedy Jr. They both pushed for him to come back, arguing that his leadership was important for CBER’s stability and ongoing biologics work.
Regulatory instability in a high-stakes field
CBER oversees vaccines, gene therapies, and biologics, all of which are critical and often high-risk interventions. Prasad’s abrupt exit and equally quick return send mixed signals, raising concerns that the agency’s direction could shift unpredictably and affect confidence in its decision-making standards.
Sarepta’s gene therapy
The pause and restart of Elevidys over safety concerns played a key role in Prasad’s exit and quick return. It showed how hard it is to balance safety with fast access to new treatments, and the way the case was managed put more focus on his leadership.
The Elevidys case showed how a single high-profile drug decision can magnify every move the FDA makes. The pause and restart of its review drew intense attention from patients, industry, and policymakers, creating an environment where outside critics could revive past controversies against agency leaders. Dr. Vinay Prasad’s resignation and reinstatement illustrate how, under political pressure, past remarks can be used to challenge current decisions, and how sensitive FDA leadership becomes when scientific judgment and politics converge.
References
Vinay Prasad Returns to FDA After Being Ousted, US News, 11 Aug 2025, https://www.usnews.com/news/health-news/articles/2025-08-11/vinay-prasad-returns-to-fda-after-being-ousted
Prasad Back at CBER after 10-Day California ‘Vacation’, Biospace, 09 Aug 2025, https://www.biospace.com/fda/prasad-back-at-cber-after-10-day-california-vacation
Dr Vinay Prasad’s FDA exit in less than 3 months linked to Sarepta gene therapy controversy? Check details, The Economic Times, 30 July 2025, https://economictimes.indiatimes.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?from=mdr
Indian Origin Dr. Vinay Prasad returns to FDA weeks after exit; Laura Loomer calls it ‘egregious decision’ Times of India, 10 Aug 2025, https://timesofindia.indiatimes.com/world/us/indian-origin-dr-vinay-prasad-returns-to-fda-weeks-after-exit-laura-loomer-calls-it-egregious-decision/articleshow/123217688.cms