CBER head Vinay Prasad resigns amid controversy

Vinay Prasad has left the FDA after less than three months as director of CBER, a government spokesperson confirmed to media outlets late Tuesday.

Prasad, who in addition to regulating vaccines and CGTs, was also the FDA’s chief medical and scientific officer, did not want to distract from the “great work of the FDA in the Trump administration” and has opted to spend more time with his family, an HHS spokesperson told media sources.

FDA Commissioner Marty Makary had named the hematologist-oncologist as CBER head in May, replacing Dr. Peter Marks who resigned under pressure in March. Prasad had been openly critical of Marks, including his handling of COVID vaccine approvals, as well as his decision to overrule other reviewers in the approval of Sarepta’s Duchenne muscular dystrophy treatment, Elevidys — a gene therapy that, according to Prasad, “has no evidence it helps boys.” In the same blog post, Prasad wrote that Marks was a “long-time proponent of lowering the bar for gene therapy” and “one of the most dangerous, pro-pharma regulators of the 21st century.”

During his brief tenure at CBER, Prasad limited the use of COVID vaccines and highlighted warnings about a rare cardiac side effect of the shots. He also became tangled in a public dispute with Sarepta, after the company refused to halt shipments of Elevidys following an FDA request that cited recent patient deaths.

Prasad’s pushback on Elevidys recently made him the target of right-wing outrage, with far-right political activist Laura Loomer launching an anti-Prasad social media campaign claiming, “A wolf in sheep’s clothing is sabotaging President Trump’s bold Make America Healthy Again agenda!” and a WSJ opinion piece calling Prasad a “Bernie Sanders acolyte” and lambasting him for not trusting patients to make their own health care decisions.