Dr. Vinay Prasad, a controversial critic of the US Food and Drug Administration (FDA), has resigned less than three months after being appointed head of the FDA’s Center for Biologics Evaluation and Research in early May 2025. He was also the FDA’s chief medical and scientific officer, overseeing vaccines and biologic medicines.
A spokesperson for the Department of Health and Human Services (HHS) stated that Prasad chose to step down to avoid being "a distraction to the great work of the FDA in the Trump administration" and return to California to spend more time with his family.
Prasad, a hematologist oncologist, was well known for his vocal criticism of the FDA’s previous decisions and the government’s handling of the COVID-19 pandemic. His tenure at the FDA was marked by controversy, including his opposition to broad use of new COVID-19 vaccine versions, where he overrode FDA scientists’ recommendations, advocating more restrictive approvals for older and immunocompromised individuals only.
One significant source of contention was Prasad’s stand on Sarepta Therapeutics’ gene therapy drug Elevidys for Duchenne muscular dystrophy. He had criticized the FDA’s earlier approval of the drug due to insufficient evidence of effectiveness. In July 2025, after reports of patient deaths—including one young patient in Brazil—the FDA, with Prasad’s involvement, asked Sarepta to halt shipments of Elevidys. However, one day before Prasad’s departure, the FDA unexpectedly reversed part of that decision, allowing shipments for some patients to resume while continuing the hold on others.
Prasad’s resignation followed mounting pressure from the White House and public attacks from right-wing activist Laura Loomer, who labeled him a "progressive leftist saboteur" undermining President Trump’s FDA. Other conservative figures, including former Senator Rick Santorum and editorials in the Wall Street Journal, criticized Prasad for his political views and position on FDA policies.
Despite the controversies, FDA Commissioner Dr. Marty Makary publicly defended Prasad shortly before his resignation, calling him an “impeccable scientist” and “one of the greatest scientific minds of our generation.” The HHS spokesperson also thanked Prasad for his service and the reforms he was able to enact during his tenure.
In summary, Dr. Vinay Prasad’s short stint at the FDA was turbulent due to his critical stance on several FDA-approved treatments and vaccine policies amidst pressure from political factions. His departure signifies continued challenges within the FDA’s leadership during a politically charged era marked by debates over public health measures and drug approvals.
