Dr. Vinay Prasad will depart his position as head of the U.S. Food and Drug Administration’s vaccines and biologic medicines unit at the end of April, the agency confirmed Friday, marking his second exit from the role under Commissioner Dr. Marty Makary.
Prasad’s departure follows a period of controversy surrounding his decisions at the FDA, including a recent refusal to immediately review a fresh influenza vaccine utilizing messenger RNA technology developed by Moderna. The agency later accepted the application after adjustments were made, according to CNN reporting.
The move comes as Prasad has faced criticism for decisions that, according to the New York Times, overrode agency scientists and rejected potential drugs. Politico reported that Prasad “ran afoul of pharma” during his tenure, suggesting friction with the pharmaceutical industry.
Prasad previously left the agency in July 2025, less than three months into the job, before returning weeks later. That initial departure occurred amid pressure from outside groups, including accusations of political alignment, as reported by the Associated Press.
In a rare move, the FDA’s Center for Biologics Evaluation and Research (CBER) recently held a media call to defend its decision-making process and address criticism related to requests for additional trial data from UniQure, a company developing a gene therapy for Huntington’s disease. This defensive posture underscores the heightened scrutiny CBER has faced under Prasad’s leadership.
Prior to rejoining the FDA, Prasad was a professor at the University of California, San Francisco, where he was an outspoken critic of the government’s initial Covid-19 response. His past criticisms have contributed to the perception of him as a divisive figure within the scientific community.
As of Friday, Dr. Makary had not announced a replacement to lead CBER, according to a social media post from the commissioner.
