Vinay Prasad, MD, MPH, has resigned from his position as director of the FDA’s Center for Biologics Evaluation and Research (CBER) after just a few months in the role. The announcement comes amid ongoing controversy over decisions related to gene therapy approvals and COVID-19 vaccine policy. According to a spokesperson for the US Department of Health and Human Services, Prasad stepped down to “avoid becoming a distraction to the important work of the FDA under the Trump administration” and will return to California to spend more time with family.1
Prasad’s resignation follows a high-profile dispute with Sarepta Therapeutics over its gene therapy delandistrogene moxeparvovec (Elevidys) for Duchenne muscular dystrophy (DMD). The therapy was temporarily paused after FDA safety investigations were launched in response to reports of three patient deaths. On July 28, Sarepta resumed shipments to ambulatory patients following the FDA’s determination that the latest death under review was unrelated to the treatment.1
The FDA’s recommendation to lift the shipment pause highlights the complex balance between ensuring patient safety and providing timely access to novel therapies. This challenging regulatory environment, marked by cautious oversight and contentious decisions during Prasad’s tenure at CBER, likely contributed to the pressures influencing his decision to step down.2
In May, Prasad, as FDA’s CBER director, co-authored new vaccine guidelines with FDA Commissioner Marty Makary that scaled back COVID-19 vaccine recommendations. The updated policy no longer advises annual COVID shots for healthy people under 65 but continues them for older adults and those with risk factors. The FDA also now requires placebo-controlled trials for vaccine approval in healthy groups, reflecting Prasad’s more cautious, evidence-focused approach to COVID-19 vaccination. Additionally, Prasad overruled FDA scientists on several regulatory decisions, limiting broader access to Moderna’s next-generation mRNA vaccine and the Novavax vaccine, which had been recommended for approval in adolescents and adults. Instead, he authorized their use only in individuals aged 65 and older or those with underlying health conditions, and restricted Moderna’s pediatric COVID vaccine to high-risk children despite internal recommendations for broader approval.3
What You Need To Know
Prasad stepped down after a few months as FDA’s CBER director, citing a desire not to distract from agency work and to spend more time with family.
His tenure featured high-profile disputes over gene therapy safety for Duchenne muscular dystrophy and a cautious overhaul of COVID-19 vaccine recommendations limiting shots to high-risk groups.
Prasad’s evidence-focused leadership drew praise for scientific rigor but also sparked criticism from conservative media and concerns about the FDA’s approach to drug approvals under his watch.
In addition to vaccine decisions, Prasad’s division recently rejected several drug applications, including a gene therapy for Sanfilippo syndrome type A (Ultragenyx), a cell therapy for DMD-associated cardiomyopathy (Capricor Therapeutics), and an advanced melanoma treatment (Replimune).1
Prasad, known for his academic work in evidence-based medicine, had previously drawn attention for statements emphasizing the need to contextualize evidence in rare and serious conditions. His appointment was initially seen as a signal of a more rigorous scientific direction under FDA Commissioner Marty Makary, MD, MPH, who described Prasad as “an impeccable scientist” and praised his leadership and impact on agency culture.1
Although, criticism from conservative media escalated in recent weeks, with some commentators questioning Prasad’s political alignment and influence on regulatory policy. Notably, a Wall Street Journal editorial raised concerns about the FDA’s handling of gene therapy approvals under his leadership, suggesting it could deter future drug development.1
Prasad’s exit comes after the departure of his predecessor, Peter Marks, MD, PhD, who left the post in April following reported disagreements with HHS leadership.1
References
1.Fiore K. FDA’s Top Vaccine Official Resigns — Vinay Prasad was only in place as CBER director for a few controversial months. MedPage Today. Published July 30, 2025. Accessed July 30, 2025. https://www.medpagetoday.com/washington-watch/fdageneral/116734
2.Sarepta Therapeutics, Inc. FDA informs Sarepta that it recommends that Sarepta remove its pause and resume shipments of ELEVIDYS for ambulatory individuals with Duchenne muscular dystrophy. Business Wire. Published July 28, 2025. Accessed July 30, 2025. https://investorrelations.sarepta.com/news-releases/news-release-details/fda-informs-sarepta-it-recommends-sarepta-remove-its-pause-and
3.Prasad V, Makary MA. An Evidence-Based Approach to Covid-19 Vaccination. N Engl J Med. Published online May 20, 2025. doi:10.1056/NEJMsb2506929
