Vinay Prasad exits FDA after Elevidys drug controversy

Anabelle Colaco
01 Aug 2025, 09:10 GMT+10

Vinay Prasad, the chief medical and science officer at the U.S. FDA, has left the agency, according to the U.S. Department of Health and Human Services, which confirmed his departure
His resignation follows a series of controversial decisions involving the FDA’s handling of Elevidys, a gene therapy developed by Sarepta Therapeutics for Duchenne muscular dystrophy
The agency initially paused distribution of the treatment after the deaths of several patients but reversed the suspension earlier this week

WASHINGTON, D.C.: Vinay Prasad, the chief medical and science officer at the U.S. Food and Drug Administration (FDA), has left the agency, according to the U.S. Department of Health and Human Services (HHS), which confirmed his departure.

"Dr. Prasad did not want to be a distraction to the great work of the FDA in the Trump administration and has decided to return to California and spend more time with his family," an HHS spokesperson said in an emailed statement to Reuters. "We thank him for his service and the many important reforms he was able to achieve in his time at the FDA."

His resignation follows a series of controversial decisions involving the FDA's handling of Elevidys, a gene therapy developed by Sarepta Therapeutics for Duchenne muscular dystrophy. The agency initially paused distribution of the treatment after the deaths of several patients but reversed the suspension earlier this week.

STAT News was the first to report Prasad's departure. The outlet previously noted in June that Prasad had been named to the FDA's top science post, citing an internal memo.

In May, Prasad, an oncologist known for publicly criticizing FDA leadership and COVID-19 policies, was also appointed director of the FDA's Center for Biologics Evaluation and Research.

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