Vinay Prasad, the controversial head of the Food and Drug Administration office that regulates vaccines and gene therapies, will again leave the agency, a spokesperson for the Department of Health and Human Services confirmed Friday.

Prasad’s planned departure in April, first reported by the Wall Street Journal, will end a tumultuous tenure during which he reworked vaccine guidelines and appeared to set a higher bar for rare disease drug approvals. The announcement comes only days after an unusual public spat between the agency and UniQure, the developer of one such rare disease treatment that now faces a much longer road to approval than it had anticipated.  

In a statement on the social media platform X, Commissioner Martin Makary cited the “long-lasting reforms” Prasad helped instill over his tenure, from a new pathway for bespoke therapies to shortened pivotal trial requirements and a “national priority” drug review program. 

“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,” Makary said. “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.”

The departure will mark the second time in less than a year that Prasad has signaled plans to leave the agency. Prasad was first named the head of the FDA’s Center for Biologics Evaluation and Research last May. He stepped down only two months later, in the wake of a messy dispute between the FDA and Sarepta Therapeutics over the Duchenne muscular dystrophy treatment Elevidys. Prasad returned to his post less than two weeks later, though, at the agency’s request. 

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