Dr. Vinay Prasad, head of the U.S. Food and Drug Administration’s vaccine and gene therapy division, is leaving the agency next month to return to his previous career in academia, FDA Commissioner Marty Makary said Friday local time.
In the X post, Makary said, Dr. Prasad came to the FDA a year ago to implement 4 major long-term reforms: the 2:1 pivotal trial requirement, the national priority rating, the risk-stratified covid vaccine framework, and the new credible mechanism framework for ultra-rare diseases “which we launched last week.”
The FDA commissioner thanked Prasad for his service at the Center for Biologics Evaluation and Research and said his division achieved a record number of approvals in December. “He got a tremendous amount of work done during his year off,” he said. “I would like to thank him for his service and the personal sacrifices he took away from his family.”
The FDA plans to appoint a successor before Prasad leaves, Makary said.
Who is Dr. Vinay Prasad?
Dr. Vinay Prasad is a retired professor of epidemiology at the University of California, San Francisco. Prasad joined the FDA in May 2025, replacing Peter Marks.
Prasad made headlines for his criticism of the Covid vaccine for children and companies not testing their treatment against placebo controls. He also had to leave the agency in late July after conservative pundits railed against him over his handling of gene therapy company Sarepta Therapeutics Inc.
But he returned just a few weeks later with the support of Makara.
During his time at the FDA, Prasad said the agency would require more vaccine testing due to safety concerns.
In a memo to staff in late November, he blamed the shots on Covid for a role in the deaths of 10 children without providing evidence.
Prasad has also spearheaded some new initiatives to promote rare disease drugs, such as unveiling faster access to the approval of customized gene editing therapies.
The end of Prasad’s tenure is a “sigh of relief” for the biotech industry.
News of Dr. Vinay Prasad’s departure sent biotech stocks higher in late trading on Friday. The end of Prasad’s tenure is a “sigh of relief” for the biotech industry, BMO Capital Markets analyst Evan Seigerman said in a note to clients.
According to a Bloomberg report, Prasad caused controversy during his time for occasionally overriding his own scientific review. He also reportedly took a confrontational approach that critics say would stifle scientific innovation and slow the approval of rare disease drugs.
Bloomberg cited biotech companies as saying that Prasad is raising the bar and making it more difficult to approve new therapies. He also faced backlash over the decision not to review Moderna Inc.’s application. for a new flu vaccine. The agency soon turned around.
UniQure NV jumped as much as 70% in after-market trading on the news of Prasad’s departure. The company has been involved in a public dispute with its division over requirements to obtain approval for its gene therapy for Huntington’s disease. Shares of Regenxbio Inc. increased by up to 29%. Last month, the FDA rejected his gene therapy for Hunter syndrome.
