WASHINGTON — The Food and Drug Administration’s embattled vaccine chief, Dr. Vinay Prasad, is leaving the agency again — his second departure in less than a year following a string of contentious decisions over vaccines and specialty drugs for rare diseases.
FDA Commissioner Marty Makary informed staff in an email Friday that Prasad will depart at the end of April and return to his academic post at the University of California, San Francisco.
Prasad was briefly forced out in July after clashes with biotech executives, patient groups and conservative allies of President Donald Trump, but he was reinstated within two weeks with support from Health Secretary Robert F. Kennedy Jr. and Makary.
His latest exit comes amid several high-profile disputes over the FDA’s handling of vaccines, gene therapies and biotech treatments, with critics accusing the agency of reversing prior positions and, in some cases, demanding new trials for products previously considered acceptable.
In recent weeks Prasad faced criticism for multiple agency actions. He initially refused to let the FDA accept for review a widely anticipated mRNA flu vaccine from Moderna — an uncommon move that prompted Moderna to publicly challenge the decision. A week later, the agency reversed course and agreed to review the vaccine, contingent on an additional study from Moderna.
Separately, the FDA engaged in a rare public confrontation with UniQure, a small company developing a gene therapy for Huntington’s disease, which 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; the company argued this contradicted earlier FDA guidance and raised ethical concerns. The FDA held an unusual press briefing to defend the request, with a senior agency official — speaking anonymously — calling the original study “stone cold negative” and saying, “We have a failed product here.”
Prasad’s tenure as the FDA’s top regulator for vaccines and biologics has been marked by similar clashes with industry. More than half a dozen companies working on therapies for rare or difficult-to-treat conditions have received rejection letters or requests for additional studies, potentially delaying development by years and increasing costs substantially.
A longtime academic and critic of FDA review standards, Prasad arrived at the agency last May and has taken an approach that has confounded observers. He and Makary have on several occasions announced efforts to streamline and speed drug reviews, yet Prasad has also imposed new warnings and study requirements for some biotech drugs and vaccines — including COVID-19 shots, which have been a focus of Kennedy, a longtime vaccine skeptic prior to joining the administration.