The FDA’s dramatic summer continues to unfold as news broke late Tuesday evening that Vinay Prasad will depart the agency, where he had been the head of the Center for Biologics Evaluation and Research for less than three months.
Vinay Prasad is out as director of the FDA’s Center for Biologics Evaluation and Research—not three months after being named to the job, according to reports from multiple sources late Tuesday evening.
“Dr Prasad did not want to be a distraction to the great work of the FDA in the Trump administration,” a Health and Human Services spokesperson told Endpoints News Tuesday, when confirming his departure.
Prasad’s exit follows a rollercoaster month that most recently saw the FDA compel Sarepta Therapeutics to voluntarily halt all shipments of its AAV-vectored gene therapy for Duchenne muscular dystrophy, Elevidys, after the deaths of two teenage patients, and a third death of a participant in a trial for the company’s SRP-9004 in limb-girdle muscular dystrophy, a gene therapy that also uses an AAV vector. On Friday, after the death of an 8-year-old Brazilian patient who had been treated with Elevidys was revealed, the FDA launched an investigation. This concluded Monday—after less than one business day—when the regulator determined that the death was not linked to Elevidys and recommended that the voluntary hold for ambulatory DMD patients be lifted.
Prasad’s departure also follows a campaign by conservative personalities, including Laura Loomer, to get rid of the CBER chief. On her website earlier this month, Loomer claimed that Prasad was a “progressive leftist saboteur” working to undermine President Donald Trump’s agenda within the FDA. And in an opinion piece published in the Wall Street Journal on Sunday, Editor Allysia Finley called Prasad a “Bernie Sanders acolyte in MAHA drag,” and said to think of him as a “one-man death panel,” who doesn’t think patients can be trusted to make their own healthcare decisions.
Notably, Prasad had joined FDA Commissioner Marty Makary in making supportive statements regarding making rare disease treatments available to patients. During a keynote speech at an event organized by the National Organization for Rare Disorders in June, Prasad committed to giving rare disease patients rapid access to “products that are even small steps forward.”
Prasad also served as the agency’s chief medical and scientific officer—roles unusual for the CBER director’s portfolio.
