FDA’s Top Vaccine Regulator Leaves Amid Controversy

Vinay Prasad, the Food and Drug Administration’s (FDA) top vaccine regulator and chief scientific officer and a critic of its COVID-19 policies, has resigned after less than three months on the job, The Hill reported on Wednesday.

His departure comes amid both increasing criticism from right-wing figures and a regulatory showdown with a drug manufacturer over a gene therapy treatment for boys with Duchenne muscular dystrophy.

“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,” a Department of Health and Human Services (HHS) spokesman said in an statement. “We thank him for his service and the many important reforms he was able to achieve in his time at FDA.”

Laura Loomer, an outside activist who has significant sway with President Donald Trump, has criticized Prasad in recent days, calling him a “saboteur” and “Trojan horse” of the administration’s “Make America Healthy Again” policy.

She wrote on her website that “far from being the reformist ally the Trump administration expected he may be, Prasad’s liberal ideology, outspoken anti-Trump rhetoric, and deliberate actions to obstruct the president’s deregulatory agenda make him a dangerous misfit in this critical position.”

Former Republican Pennsylvania Sen. Rick Santorum added on X that Prasad was “destroying @POTUS legacy for helping patients.”

Prasad was named head of the FDA’s Center for Biologics Evaluation and Research in May as a replacement for Peter Marks, who quit in March after disagreements with HHS Secretary Robert F. Kennedy Jr., according to The Hill.

Prasad’s division has been in a regulatory dispute in recent weeks with Sarepta Therapeutics, the manufacturer of a gene therapy for Duchenne muscular dystrophy. The FDA ordered Sarepta to stop all shipments of its treatment and clinical trials following the deaths of two patients who received the drug.

Before his position at the FDA, Prasad was a critic of the agency’s initial decision to approve the treatment. The administration granted accelerated approval for Elevidys two years ago despite dubious evidence of its effectiveness to stop or reverse symptoms of the disorder. To grant the approval, Marks overrode multiple agency review teams that recommended against it.

On Monday, the agency issued a statement partially reversing itself, removing the pause for patients who can still walk.

FDA’s Top Vaccine Regulator Leaves Amid Controversy

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