FDA vaccines chief who ran afoul of pharma to depart

Vinay Prasad, the Trump administration regulator who angered pharma companies and crushed the hopes of patients with rare diseases with a series of controversial decisions to reject new drug applications, will leave the agency next month.

Food and Drug Administration Commissioner Marty Makary said Friday Prasad, director of the agency’s Center for Biologics Evaluation and Research, will depart at the end of April.

Prasad’s exit comes as he’s drawn sharp criticism in recent weeks for his handling of rare disease therapy candidates before the agency.

His departure also coincides with an effort by the Trump administration ahead of the midterms to pivot away from controversial regulatory moves on vaccines — the availability of which polls show the public largely supports — toward improving the American diet and battling chronic disease. Most of Health Secretary Robert F. Kennedy Jr.’s public appearances in recent weeks have focused on that part of his Make America Healthy Again agenda.

Prasad started at the agency last May and drew controversy almost immediately for raising the bar on new drug approvals — a posture praised by some researchers who say the FDA has allowed too many treatments with questionable benefits onto the market over the years. The White House forced him out over the summer only to rehire him after Makary and Kennedy pleaded for reconsideration.

President Donald Trump during his first term signed “right-to-try” legislation aimed at making it easier for patients with incurable, terminal diseases to gain access to experimental therapies.

In a post on X, Makary said Prasad would now return to his teaching position at the University of California San Francisco, framing his FDA work as part of a “one-year sabbatical” from academia.

On a call with reporters Thursday, a senior FDA official — speaking on condition of anonymity under ground rules set by HHS — gave no hint Prasad was on the way out, saying he served “at the pleasure of the commissioner and the secretary and the president” and would continue to do so.

The most recent furor involving Prasad has surrounded the FDA’s interactions with Dutch biopharma company Uniqure, whose gene therapy for Huntington’s disease, a deadly brain condition that affects about 40,000 Americans and for which there is no cure, was dealt a setback after the agency said late last year that its earlier studies were inadequate to support a biologics license application.

The company said that contradicted the FDA’s 2024 feedback — an increasingly common complaint among several rare-disease drug companies trying to advance their therapy candidates through the agency under new leadership.

Uniqure executives said during a Monday earnings call that the FDA had “strongly recommended” the company conduct a randomized, double-blinded trial with a so-called sham surgery — in which control group participants are anesthetized so doctors can simulate the drilling necessary for infusion treatment. The development surprised financial analysts and patient advocates alike, and the company questioned whether such an approach would be ethical for patients with Huntington’s, which is progressive and ultimately fatal, typically in middle age.

The FDA official pushed back Thursday on Uniqure’s statements, saying the agency recommended a control group receive “one to three nicks in the scalp” as opposed to a burr hole as needed for the gene therapy. The superficial cuts would only warrant 30 minutes of anesthesia rather than 10 hours, the official said, later adding that a “long history” of sham surgeries have been used in trial control groups.

The dispute was one in a string of controversies that have dogged Prasad, a longtime skeptic of approving drugs and vaccines without what he considers to be rigorous data.

His first months-long tour at the FDA ended in July after Trump ordered his removal, overruling Makary and Kennedy, POLITICO previously reported.

At the time, prominent conservatives criticized Prasad’s stewardship of rare disease therapy applications after the FDA asked Duchenne muscular dystrophy drugmaker Sarepta Therapeutics to pause all shipments after reports of patient deaths. The company initially balked, wanting to continue distributing treatments for those who could still walk, but later agreed, though the agency reversed itself just days later.

Duchenne muscular dystrophy affects a small number of boys and young men who typically lose their ability to walk before they hit puberty and die by age 30.

Less than two weeks later, Prasad was back on the job after Makary and Kennedy lobbied the White House for his reinstatement, POLITICO previously reported. Trump’s chief of staff, Susie Wiles, was also a key factor behind his rehiring.

While both of Prasad’s departures come amid criticism of his rare disease therapy oversight, he’s also drawn fire for his stewardship of vaccine approvals. Like Makary, Prasad forged a reputation during the Covid-19 pandemic as a sharp critic of federal recommendations, including vaccine guidance for children.

He and Makary wrote a scientific paper in May outlining a new FDA approval framework for Covid vaccines last year. The agency, they said, would essentially limit its approval of future Covid vaccines to those 65 and older or to people with an underlying condition.

In November, Prasad claimed in an internal memo that the agency had data showing “at least” 10 children died after getting Covid shots. The agency has never released the data, which Prasad said was based on voluntary reports to an adverse event system that does not prove causation between alleged injuries and vaccination.

And last month, mRNA vaccinemaker Moderna disclosed that Prasad had sent it a letter refusing to accept its application to market a seasonal flu vaccine because he took issue with its clinical trial design.

The company took the rare step of publicly releasing the correspondence and describing previous written statements from the agency signaling it could accept Moderna’s proposed design, even though reviewers preferred a different vaccine for the comparison arm. Department officials accused Moderna of trying to game its trial results by comparing its vaccine candidate to a flu shot that may not work as well in adults 65 and older.

But within days, the FDA reversed course and accepted Moderna’s application for review. The decision followed a regulatory meeting in which the company proposed an alternative review approach — the FDA will now consider the shot for full approval for 50- to 64-year-olds and accelerated approval for adults 65 and older, with a post-marketing study requirement for the latter age group.

That move also followed a White House meeting between Makary and Trump, who vented his frustration over the agency’s handling of vaccine issues, POLITICO previously reported.

On X, Makary said Prasad came to the agency to establish four “major long-lasting reforms” — new regulatory frameworks for Covid vaccine approvals and for ultra-rare disease therapies, a national priority review program and a shift toward requiring one pivotal trial for drug approval instead of two.