For the second time in less than a year, Vinay Prasad, the head of the U.S. Food and Drug Administration’s vaccines unit, is leaving the agency, according to a statement from the FDA commissioner, Marty Makary.
Prasad will depart as the director of the FDA’s Center for Biologics Evaluation and Research (CBER) at the end of next month, Makary said in an X post on Friday.
A professor in the epidemiology and biostatistics department at the University of California, Prasad joined the FDA in May 2025 after the former CBER head, Peter Marks, abruptly resigned from the position. He was later given the additional role of the FDA’s chief medical and scientific officer in June.
Prasad suddenly left the agency in late July in the aftermath of the FDA response to the several deaths linked to Elevidys, a treatment for Duchenne muscular dystrophy developed by Sarepta Therapeutics (SRPT) and Bayer (BAYRZF).
After rejoining the FDA in August to assume his original position as the director of CBER, Prasad oversaw several controversial decisions at CBER, most recently the FDA’s handling of an experimental therapy developed by uniQure (QURE) targeting a rare disorder called Huntington’s disease.
“Under his leadership, his center hit a record number of approvals in Dec.,” Makary wrote in an X post last night, adding, “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.”
The FDA will name Prasad’s successor before his departure, Makary said.