WASHINGTON — Dr. Vinay Prasad, the Food and Drug Administration’s contentious top official for vaccines and biologics, will leave the agency at the end of April and return to his academic position at the University of California, San Francisco, FDA Commissioner Marty Makary informed staff in an email Friday. This marks Prasad’s second departure in under a year after a period of heated disputes with industry, patient groups and some political allies.
Prasad was briefly forced out last July following clashes with biotech executives, patient advocates and conservative supporters of President Donald Trump, but he was reinstated within two weeks after receiving backing from Health Secretary Robert F. Kennedy Jr. and Makary.
His latest exit comes as the agency faces several high-profile controversies over vaccines, gene therapies and other biotech treatments. Critics have accused the FDA under Prasad of reversing earlier positions and, in some cases, requiring new trials for products that had previously been considered acceptable.
In recent weeks Prasad drew criticism for a number of agency actions. He initially blocked the FDA from accepting for review a much-anticipated mRNA flu vaccine from Moderna — an uncommon move that led Moderna to publicly challenge the decision. A week later, the agency agreed to review the vaccine but tied that acceptance to an additional study from Moderna.
Separately, the FDA sparred publicly with UniQure, a small developer of a gene therapy for Huntington’s disease, a condition that affects roughly 40,000 people in the U.S. UniQure said the agency demanded a new trial that would include sham surgery for some participants, arguing that such a requirement conflicted with prior FDA guidance and raised ethical concerns. The agency held an unusual press briefing to defend the request, and an anonymous senior official called the original study “stone cold negative,” adding, “We have a failed product here.”
Prasad’s time overseeing vaccines and biologics has been marked by similar conflicts with industry. More than half a dozen companies working on treatments for rare or difficult-to-treat conditions have received rejection letters or been asked to conduct additional studies, moves that could delay development by years and substantially raise costs.
A longtime academic and critic of FDA review standards, Prasad joined the agency last May. Observers say his approach has been inconsistent: he and Makary have announced measures aimed at streamlining and accelerating drug reviews, yet Prasad has also instituted new warnings and study requirements for certain biotech drugs and vaccines — including COVID-19 shots, which have been an area of focus for Kennedy, who was a vocal vaccine skeptic before joining the administration.