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On the way out

Trump’s divisive FDA vaccine regulator self-destructs, will exit agency (again)

It’s unclear what Prasad’s FDA exit means, but some drug makers are happy to see him go.

Beth Mole – | 65
Vinay Prasad Credit: Getty | Marvin Joseph
Vinay Prasad Credit: Getty | Marvin Joseph
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For the second time, Vinay Prasad is set to leave the Food and Drug Administration.

In a post on social media Friday, FDA Commissioner Marty Makary announced that Prasad will exit in April, adding that he got “a tremendous amount accomplished” during his year at the agency.

Prasad’s tenure was generally marked by controversy, but he is departing amid a cluster of self-destructive decisions. Those include a shocking rejection of an mRNA vaccine (which was over the objections of agency scientists and quickly reversed); a demand for an additional clinical trial on a gene therapy for Huntington’s disease, which was widely seen as moving the goalpost for the therapy; his startling choice to publicly attack the maker of that gene therapy, UniQure; and alleged abuse of FDA staff, who say he created a toxic work environment.

The moves have collectively roiled those within the agency, the Trump administration, the biotechnology and pharmaceutical industries, as well as patient advocacy groups.

On Monday, BioSpace reported that financial analysts were all but cheering Prasad’s departure, calling it “a big win for biotech, especially for companies in the rare disease space.” Several biotech companies that have faced setbacks and rejections at the hands of Prasad saw stock bumps on Monday. UniQure, for instance, saw its stock leap around 25 percent from Friday afternoon.

Constant controversy

This will be Prasad’s second exit from the FDA during the current Trump administration. In July, he resigned amid his controversial handling of a gene therapy treatment for Duchenne muscular dystrophy, as well as criticism from far-right activist Laura Loomer, who called Prasad a “leftist saboteur.” He was reinstated less than two weeks later.

Since his return, Prasad has held key roles at the FDA; he is the chief medical and scientific officer and the director of the Center for Biologics Evaluation and Research (CBER), which also makes him the top regulator of vaccines, gene therapies, and other biologic products.

His qualifications for those roles were always questionable. While Prasad is a professor at the University of California, San Francisco and a practicing hematology-oncologist (a doctor specializing in blood disorders and cancers), he came to the FDA with no regulatory experience and no expertise in vaccines or gene therapies. Prasad’s rise to regulatory relevance stemmed instead from his online criticism of pandemic-era public health policies, including COVID-19 vaccines, and his appearances on podcasts.

His undoing appears to stem from continuing to act more like a brash podcaster than a level-headed federal regulator who understands the FDA’s measured procedures.

In November, Prasad wrote a memo to staff, unilaterally announcing sweeping changes to how the agency regulates vaccines. He included a warning that staff who disagreed with his style should resign. He also included a claim that the COVID-19 vaccine killed 10 children but has yet to provide any evidence to back that extraordinary claim.

After that memo leaked, 12 former FDA commissioners united to write a scathing rebuke to Prasad’s directives, calling him a “threat” to the agency’s evidence-based work.

The last straw

In his time at the FDA, he was known for overruling staff scientists and career officials and blindsiding companies with rejections or moved goalposts. But his treatment of UniQure reached a new level of egregiousness.

UniQure’s gene therapy for Huntington’s—for which there are no current treatments—could slow progression of the disease by 75 percent. In 2024, the FDA told the company that it could submit its therapy for an accelerated approval without having a placebo-control arm in its trial. The therapy requires a 10–12-hour brain surgery, thus a placebo-controlled trial would require some patients to undergo a lengthy sham surgery that could involve drilling a superficial hole in the skull, raising clear ethical concerns.

But, under Prasad, the FDA reversed course, telling the company that it needed those sham surgeries. Last week, the FDA doubled down on the requirement.

In a New York Times report Thursday about the FDA’s growing denials, Janet Woodcock—a retired FDA official who was with the agency for nearly 40 years—blasted the FDA’s UniQure decision, calling it “truly evil.”

The criticism apparently struck a nerve with Prasad. The FDA held a press briefing later Thursday in which an unnamed “senior FDA official”—who identified himself as a hematology-oncologist—launched into a diatribe against UniQure, saying its “failed therapy” was supported by “distorted and manipulated” data. As for Woodcock’s comments, the official said he “expect[s] better” from her.

When a reporter asked the official how long he would stay at the agency, he responded that he missed speaking freely on his podcast and working as a hematology-oncologist, but would “serve happily” as long as he was “in alignment” with Makary and Trump.

Makary said Friday that Prasad’s replacement will be announced before his departure.

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Beth Mole Senior Health Reporter
Beth is Ars Technica’s Senior Health Reporter. Beth has a Ph.D. in microbiology from the University of North Carolina at Chapel Hill and attended the Science Communication program at the University of California, Santa Cruz. She specializes in covering infectious diseases, public health, and microbes.
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