Vinay Prasad, the top vaccine regulator and chief scientific officer at the Food and Drug Administration (FDA) and a critic of the agency’s COVID-19 policies, has departed after being on the job for less than three months.
“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 spokesman for the Department of Health and Human Services (HHS) said in an emailed statement. "We thank him for his service and the many important reforms he was able to achieve in his time at FDA."
The spokesman did not say who would replace Prasad or provide a reason for his sudden departure.
Prasad’s resignation comes amid mounting criticism from right-wing figures, including activist Laura Loomer and former Sen. Rick Santorum (R-Pa.), that coincided with a regulatory showdown with drug manufacturer over a gene therapy treatment for boys with Duchenne muscular dystrophy.
Loomer, an outside activist who has extraordinary sway with President Trump, has been attacking Prasad on social media and on her website in recent days. She’s called him a “saboteur” and “trojan [sic] horse” of the administration’s “Make America Healthy Again” initiative.
“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,” Loomer wrote on her website.
Her attacks were amplified by Santorum, who claimed in a post on social platform X that Prasad was “destroying @POTUS legacy for helping patients.”
A few days later, a Wall Street Journal opinion column labeled Prasad “a young disciple of Bernie Sanders” and accused him of “scuttling potentially life-saving therapies.”
Prasad was named head of the FDA’s Center for Biologics Evaluation and Research in early May as a replacement for Peter Marks, the longtime leader of division who resigned in March after clashing with HHS Secretary Robert F. Kennedy Jr.
Prasad’s division has been involved in a regulatory dispute in recent weeks with Sarepta Therapeutics, the manufacturer of a gene therapy for Duchenne muscular dystrophy. The FDA forced Sarepta to stop all shipments of its treatment and halt clinical trials after the deaths of two patients who received the drug.
Prior to his role at FDA, Prasad had been an outspoken critic of the agency's initial decision to approve the treatment. The administration granted accelerated approval for Elevidys in June 2023 despite dubious evidence of its effectiveness to stop or reverse symptoms of the rare, fatal genetic disorder. To grant the approval, Marks unilaterally 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.
Prasad was a key ally of FDA Commissioner Marty Makary, with whom he recently worked to narrow the approval for updated COVID-19 vaccines.
Instead of recommending the shots for everyone, Prasad said they will only be approved for use in adults 65 and older and people at high risk for severe disease.
In an interview with Politico published last weekend, Makary defended Prasad.
“There’s not a political bone to his body,” Makary said. “He’s an impeccable scientist, I think one of the greatest minds of our generation.”
Source: The Hill - News
