Trump Overrode RFK Jr. And Makary To Remove FDA Biologics Chief Amid Sarepta Drug Controversy: Report

U.S. President Donald Trump reportedly ordered the removal of Vinay Prasad as director of the FDA’s Center for Biologics Evaluation and Research (CBER), overriding opposition from Health Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary.

One of the four sources who spoke to Politico expressed concern over the move, saying, “I worry now RFK will get hardcore anti-vaxxers in there.”

Prasad had held the role for about three months and faced criticism after he and Makary requested that Sarepta Therapeutics pause shipments of Elevidys, the FDA-approved gene therapy for Duchenne muscular dystrophy, following three reported patient deaths, including two of which were linked to liver failure. 

The request drew backlash from some patient advocacy groups and conservative figures.

Sen. Ron Johnson (R-WI) reportedly raised concerns with Kennedy about the FDA’s handling of Elevidys, which led to a call with Makary. Johnson said he also texted Trump directly on Monday morning: “The Duchenne muscular dystrophy community is very concerned about some recent actions the FDA took, I just thought he ought to be aware of it.”

Following Prasad’s removal, Makary named George Tidmarsh as acting CBER director. 

The Trump administration is reportedly considering splitting CBER into two separate bodies: one focused on vaccines, and another on therapeutics.

Mary Holland, president and CEO of Children’s Health Defense, said in a statement that a qualified public health expert should fill the role. She said that the new candidate must have “a strong commitment to transparency, honest science, and protecting public health over commercial profits.” 

Sen. Rand Paul (R-Ky), an ally of Makary, expressed disappointment with the decision. “I’ve been a longtime fan of Vinay Prasad,” he said. “Followed him and a lot of his comments on evidence-based science, so I’m disappointed.”

Makary had described Prasad as a “genius” who made “tremendous” policy contributions during his short time at the FDA, according to a CNBC interview aired Wednesday.

He cited Prasad’s “brutal” commute from California and his desire not to be a “distraction” as reasons for stepping down. “We’re going to continue to talk to him,” Makary said, noting that the agency is seeing “a lot of interest from talented people” for the permanent role.

On Stocktwits, retail sentiment was ‘bearish’ for the Health Care Select Sector SPDR Fund (XLV) and ‘bullish’ for the iShares Global Healthcare ETF (IXJ), with ‘high’ message volume for both.

So far this year, XLV is down 2.5%, while IXJ has slipped 0.6%.

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