Dr. Vinay Prasad, who leads the FDA division that oversees vaccines and other biological products, will leave the agency at the end of April, FDA Commissioner Marty Makary told staff in an email. It will be Prasad’s second departure in less than a year after a brief exit last summer amid clashes over high-profile drug and vaccine reviews.
Dr. Vinay Prasad, the head of the Food and Drug Administration’s Center for Biologics Evaluation and Research, is set to depart at the end of April, according to an email FDA Commissioner Marty Makary sent to agency staff.
Makary said Prasad would return to his academic post at the University of California, San Francisco. Prasad’s exit will be his second in less than a year. He previously left the FDA in July after disputes with biotechnology executives, patient groups and conservative allies of President Donald Trump, and was reinstated less than two weeks later with the backing of Health and Human Services Secretary Robert F. Kennedy Jr. and Makary.
Prasad’s tenure has unfolded alongside a series of contentious regulatory decisions involving vaccines and experimental treatments for rare diseases. Companies have publicly criticized the agency for changing course on products that had appeared to be on track for review or approval.
One recent dispute involved Moderna’s application for an mRNA-based influenza vaccine. The FDA initially issued what is known as a “refusal-to-file” letter, meaning the agency would not begin reviewing the application. The disagreement centered on the design of a roughly 40,000-person clinical trial and whether the comparator vaccine used in the study reflected the best available standard of care for older adults. About a week later, Moderna said the FDA had agreed to proceed with a review after the company proposed a revised path that included additional post-authorization study commitments.
Separately, the FDA has engaged in an unusual public back-and-forth with uniQure, a biotechnology company developing an experimental gene therapy for Huntington’s disease, a fatal neurological disorder that affects about 40,000 people in the United States. uniQure said the FDA had asked for a new trial that would include sham surgeries for some participants, a request the company argued raised ethical concerns and conflicted with earlier feedback. The FDA held a press conference to defend its position, and an anonymous senior FDA official told reporters the company’s earlier study was “stone cold negative,” adding, “We have a failed product here.”
Beyond these episodes, Prasad’s division has faced criticism from segments of the biotechnology industry over decisions affecting multiple rare-disease programs, with companies warning that new trials can add years and substantial cost to development timelines.
Makary has said the FDA plans to name a successor before Prasad leaves.
