Food and Drug Administration (FDA) Commissioner Marty Makary on Friday announced that the agency’s top regulator Vinay Prasad will depart next month.
“A year ago, Dr. Prasad came to the FDA to implement 4 major long-lasting reforms: 2-to-1 pivotal trial requirement, national priority reviews, a risk-stratified covid vaccine framework, & the new plausible mechanism framework for ultra rare diseases which we launched last week,” Makary said of the agency’s Center for Biologics Evaluation and Research director on the social platform X.
“Also, under his leadership, his center hit a record number of approvals in [December],” Makary continued. “He got a tremendous amount accomplished within his one-year sabbatical from UCSF and will be returning back to his academic home later next month. We will name a successor before his departure. I want to thank him for his service and personal sacrifice to take time away from his family.”
Prasad’s work at the agency began in May 2025. Controversy erupted when Prasad placed restrictions on approval of COVID-19 vaccines Novavax and Moderna the same month they were approved. He limited the shots to seniors or children and adults with underlying medical issues.
His division was involved in a regulatory dispute with Sarepta Therapeutics, the manufacturer of a gene therapy for Duchenne muscular dystrophy. The FDA forced the manufacturer to stop all shipments of its treatment and halt clinical trials after the deaths of two patients who received the drug.
Conservative figures, including activist and Trump ally Laura Loomer, accused him of “sabotaging President Trump’s bold ‘Make America Healthy Again’ (MAHA) agenda” and of being a liberal.
By July 2025, Prasad resigned. A Health and Human Services (HHS) spokesperson said Prasad left due to not wanting “to be a distraction to the great work of the FDA in the Trump administration” and wanted to teach and be with his family in California. He returned to the FDA the following month.
Guidelines on vaccine approval grew more strict under Prasad’s watch in November. He sent a memo stated that manufacturers will need to conduct larger studies before seeking approval for vaccines, including for pneumonia, The New York Times reported. These larger studies would slow the process to develop vaccines.
The memo claimed these changes were due to the deaths of 10 children who died “after and because of” a COVID-19 vaccine, though the memo did not go into further detail. Prasad called this finding “a profound revelation,” The Washington Post reported after reviewing the same memo.
The FDA opened an investigation into the alleged connection the following month.
