President Donald Trump overruled his health secretary and FDA chief on Tuesday, and ordered the removal of the government’s top vaccine regulator, four people with knowledge of the decision told POLITICO.
The four, granted anonymity to speak about the details of Trump’s decision, said Health Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary opposed dismissing Vinay Prasad, who had been on the job three months and had recently come under attack by right-wing provocateur Laura Loomer.
“I worry now RFK will get hardcore anti-vaxxers in there,” one of the four said.
Prasad could not be reached for comment. The White House did not respond to a request for comment.
A close Trump ally, Loomer’s efforts against Prasad began in earnest on July 20 when she wrote on her website that Prasad, a hematologist-oncologist, was a “progressive leftist saboteur undermining President Trump’s FDA.”
Within days, she and other conservative voices — including former GOP Sen. Rick Santorum and The Wall Street Journal editorial board — slammed Prasad’s stewardship of rare disease therapies under his center’s purview, arguing his approach threatened patient choice.
Those complaints came amid a skirmish between the FDA and Sarepta Therapeutics over whether the drugmaker should pause shipments of Elevidys, a treatment for Duchenne Muscular Dystrophy, a severe genetic disorder that overwhelmingly impacts young males. Prasad vocally critiqued the decision by his predecessor, Dr. Peter Marks, to approve the drug for nearly all patients in June 2024.
The FDA asked Sarepta to pause all shipments of the therapy, but the company initially refused to do so for ambulatory patients. It subsequently agreed to the pause, but ultimately, the FDA allowed them to resume distribution on Monday to patients who can still walk.
Sen. Ron Johnson (R-Wis.) said he conveyed concern about the FDA’s approach to Elevidys to Kennedy, who set up a call with Makary. But Johnson subsequently raised the issue to the White House on Monday morning.
“I just texted President Trump on Monday just to make sure he was aware of the situation,” Johnson said Wednesday. “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.”
The criticism of Prasad’s Elevidys decision added to Loomer’s line of attacks. She called attention to his 2021 social media posts in which he called himself “a political liberal” aligned with Sens. Bernie Sanders (I-Vt.) and Elizabeth Warren (D-Mass.). Loomer also linked on July 20 to his 2020 X post expressing support for then-candidate Joe Biden to win the presidential election that November.
“Prasad’s policy positions are a direct affront to the conservative principles underpinning Trump’s agenda,” Loomer wrote, listing his support for universal health care and abortion rights.
On July 28, Loomer posted a story quoting interviews in which Prasad expressed disdain for Trump, including an apparent joke about stabbing a voodoo doll of the president to “curse” him.
Loomer could not be reached for comment on Prasad’s departure.
Makary on Wednesday announced Dr. George Tidmarsh would take over as acting director of the FDA’s biologics center — but more substantial changes could be on the horizon.
The Trump administration is weighing splitting the Center for Biologics Evaluation and Research into two bodies: one focused on vaccine regulation and one on therapeutics, according to three of the people familiar with the discussions.
That could allow Kennedy to respond to anti-vaccine groups like Children’s Health Defense, which has expressed concern he has not been as aggressive toward immunizations as they hoped. Under Prasad, the FDA approved Moderna’s Covid-19 vaccine for kids aged 6 months through 11 years at increased risk for Covid-19. Prasad was also instrumental in developing the FDA’s framework for approval of future Covid-19 booster shots.
“What matters is that a highly qualified scientist and public health expert quickly steps into this essential role at the FDA’s Center for Biologics Evaluation and Research,” Mary Holland, CHD’s president and CEO, said in a statement to POLITICO about Prasad’s exit.
She said it’s crucial that “the new candidate has a strong commitment to transparency, honest science, and protecting public health over commercial profits.”
Sen. Rand Paul (R-Ky.), an ally of Makary, said he was concerned the pharmaceutical industry’s influence may have contributed to Prasad’s removal.
“I’ve been a longtime fan of Vinay Prasad,” Paul said. “Followed him and a lot of his comments on evidence-based science, so I’m disappointed.”
In a Wednesday morning interview with CNBC Makary called Prasad a “genius” who made “tremendous” policy changes during his short tenure. The commissioner pointed to Prasad’s California roots — “the commute was brutal,” he added — and his desire to avoid being a “distraction” as reasons for his departure. Makary added: “We’re going to continue to talk to him.”
“We have a lot of interest from talented people,” he said, referring to Prasad’s yet-to-be-named full-time successor.
Eli Stokols contributed to this report.
