FDA biologics chief back 12 days after resigning, creating pressure on biotech stocks

Dr. Vinay Prasad returned to the Food & Drug Administration less than two weeks after resigning, following intense scrutiny from right wing critics who opposed his decision to remove a controversial gene therapy from the market.

The FDA said Prasad is resuming his role as director of the Center for Biologics Evaluation and Research (CBER), which oversees biologic drugs and vaccines, at the agency’s request. Insiders see the decision as a win for FDA Commissioner Marty Makary and Health and Human Services Secretary Robert Kennedy Jr., both of whom championed Prasad.

It is bad news for the biotech firms that came under scrutiny from Prasad, however, with shares of Sarepta Therapeutics initially dropping 4.3% in premarket trading on Monday, Capricor Therapeutics down 7.5%, and Replimune Group 7%.

Prasad resigned on July 29 after he called for Sarepta’s drug Elevidys be removed from the market over safety concerns. The drug, one of a very few treatments for Duchenne’s muscular dystrophy, was approved last year by Prasad’s predecessor, Dr. Peter Marks, overruling the FDA’s own reviewers who rejected the drug — an approval Prasad harshly criticized as a private physician.

Elevidys, a one-time injection that costs $3.2 million, did not meet expectations in a clinical trial. But families of children with Duchenne’s, a deadly disease with no cure, pressured the FDA to approve the drug anyway because they have so few options.

Marks, a champion of vaccines, resigned in March after clashing with Kennedy. Prasad is much more of a vaccine skeptic, and during his first three months at the FDA he tightened restrictions on Covid-19 vaccines, again over the objection of FDA staff.

Makary told reporters last week that he was trying to convince Prasad to return and that media reports suggesting that Prasad was fired after intervention from the White House are “simply untrue.” He “didn’t want to be a distraction,” Makary said.

The HHS said in a statement that “At the FDA’s request, Dr. Vinay Prasad is resuming leadership of the Center for Biologics Evaluation and Research.”

The decision infuriated conservative activist Laura Loomer, a harsh critic of Prasad who is close to President Trump. In a post on X $TWTR on Saturday, Loomer wrote “In another egregious personnel decision under the Trump administration, it is now being reported that longtime progressive Marxist Vinay Prasad who referred to President Trump’s supporters as criminals and compared them to drug addicts after saying he stabbed a Trump voodoo doll to 'curse Trump' is apparently back at FDA after @MartyMakary advocated for him."

Loomer continued, "In the coming weeks, I will be ramping up my exposes of officials within HHS and FDA so the American people can see more of the pay for play rot themselves and how rabid Trump haters continue to be hired in the Trump administration.”

Politico reported that FDA staffers are incredulous over Prasad’s return. Some 3,500 employees were laid off early in the year, and although about a quarter of those have been reinstated, the agency is still experiencing an unprecedented level of turnover and staff morale is reported to be low.

It is not yet clear whether Prasad will also resume his role as the FDA’s chief medical and scientific officer.