FDA chooses Dr. Vinay Prasad to lead biologics, vaccines division

By Sarah Owermohle and Meg Tirrell, CNN

(CNN) — The US Food and Drug Administration has named Dr. Vinay Prasad, a hematologist oncologist, to lead its Center for Biologics Evaluation and Research, the division that oversees vaccines and biologic medicines.

Prasad, a professor at the University of California San Francisco, became a harsh critic of the government’s response and its vaccine policies during the Covid-19 pandemic. He replaces Dr. Peter Marks, who helped lead the division for 13 years and shaped the Operation Warp Speed effort to rapidly develop Covid-19 vaccines and treatments.

Marks resigned from the agency in March with a letter criticizing US Health and Human Services Secretary Robert F. Kennedy Jr.’s stance on vaccine safety.

“It has become clear that truth and transparency are not desired by the Secretary, but rather he wishes subservient confirmation of his misinformation and lies,” Marks wrote.

Prasad has vocally criticized the Warp Speed effort, and Marks’ leadership, on his blog and the social media platform X, where he was often praised by now-FDA Commissioner Dr. Marty Makary for criticizing school shutdowns, mask policies and booster recommendations for the Covid-19 shot.

In an email to FDA staff obtained by CNN, Makary wrote that Prasad has a “long and distinguished history in medicine” and cites his extensive oncology research.

Prasad’s appointment to lead the Center for Biologics Evaluation and Research comes as the FDA says it will impose new requirements for future vaccines to undergo placebo studies.

Public health officials are also weighing a reversal on Covid-19 vaccine recommendations for children. Prasad has vocally questioned authorizing those shots for children, because they are at lower risk of severe infection than older people and those with weakened immune systems.

Biotech stocks tumbled more than 5% in the hours after the announcement as industry analysts called Prasad an “anti-establishment” choice and noted that he has also questioned the FDA’s used of accelerated approval processes for certain medicines.

Sarepta Therapeutics, manufacturer of one of those accelerated new medicines, saw its stock fall by nearly a quarter. Prasad has been critical of the FDA’s decision to approve Sarepta’s Elevidys, a multimillion-dollar gene therapy to treat Duchenne muscular dystrophy, despite what he saw as limited evidence of its benefits.

Prasad co-wrote a post last year that said, “Despite its high cost and potential toxicity, the clinical benefits of Elevidys remain uncertain.”

Under his leadership, the biologics division could bring more scrutiny and requirements to developers creating new gene therapies. Earlier this year, Prasad said he wanted to see more stringent reviews, writing on X that “The FDA did nothing to speed gene therapy, other than talk about how they will use uncontrolled endpoints. But we want to speed effective gene therapy, not ineffective gene therapy. The FDA had no solution for that.”

Biotech stocks were “nearly as weak” Tuesday as they were the day after President Trump announced that Kennedy would lead HHS, Mizuho Group analyst Jared Holz wrote in a note to investors.

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