Vinay Prasad’s clout as one of the most powerful medical regulators was unmistakable. And it all fell apart in a few weeks.
The doctor embraced by the right for challenging the public health establishment during the covid pandemic became a top Food and Drug Administration official after President Donald Trump returned to the White House. He oversaw vaccines and complex treatments for difficult diseases.
Yet Prasad’s skepticism of experimental therapies without proven benefit stirred powerful resistance. In mid-July, a pressure campaign pushed by far-right activist Laura Loomer began highlighting his past support for Democratic politicians and criticism of Trump. As the backlash escalated, Prasad was ousted this week at the direction of the White House, according to three people familiar with the situation who spoke on the condition of anonymity to discuss a personnel matter.
Prasad’s rapid rise and departure in less than three months show how the FDA is buffeted by diverse forces – including conservative activists, libertarian-minded Republicans, pharmaceutical interests and patient advocates – that are attempting to influence decisions about what medications Americans can get. Some of these tensions have long existed, but they are moving at a rapid clip while the Trump administration is upending the traditional public health system.
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The FDA is tasked with balancing access to medicines and protecting people from unsafe products, said Jesse Goodman, one of Prasad’s predecessors leading the agency’s Center for Biologics Evaluation and Research.
“You do that by insulating the system from political pressure, not by having scientists at the beck and call of political pressure,” said Goodman, now a professor of medicine at Georgetown University.
It’s unclear what ultimately led to Prasad’s ouster – whether it was his approach to regulating medicines, accusations of being anti-Trump or a combination of factors.
“It is not only appropriate, but critical for the Administration to recruit the most qualified and experienced staffers who are totally aligned with President Trump’s agenda to Make America Great Again,” Kush Desai, a White House spokesman, said in a statement responding to questions about Prasad’s departure.
Prasad has not publicly commented about losing his job and did not respond to a request for comment Thursday.
Andrew Nixon, a spokesman for the Department of Health and Human Services, said Prasad “did not want to be a distraction to the great work of the FDA in the Trump administration.” On CNBC Wednesday, FDA Commissioner Marty Makary called Prasad a “genius,” adding that the commute from California where he has family was “brutal” and that the agency would “continue to talk to him.”
Prasad, a hematologist-oncologist, built a reputation for demanding rigorous data. His first major move at the FDA was to end blanket approval of updated coronavirus shots unless the drugmakers presented robust evidence to prove the new formulas worked for people at lower risk of severe disease.
He brought a similar mindset to approving drugs where big money and the lives of patients with hard-to-treat diseases were at stake, according to industry analysts. The ensuing battle exposed the rifts in the Trump administration, where pledges to follow “gold-standard science” can conflict with giving patients a shot at treatment based on inconsistent data.
Loomer, a MAGA influencer who has targeted administration officials she deems disloyal, wrote July 20 that Prasad’s presence in the FDA amounted to a “betrayal of the voters who elected Trump to dismantle bureaucratic overreach and prioritize American health.”
Loomer told The Washington Post her interest in Prasad originated from a tipster within HHS who described the regulator as “one of the worst offenders as it relates to pushing a hardcore progressive Democrat agenda against the Trump administration.”
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A tense – and nuanced – debate
Prasad’s brief tenure intensified a long-simmering debate over giving sick patients desperate for a treatment access to new medications, even if the safety and efficacy was in doubt.
Speaking at a rare disease symposium in June, Prasad said the FDA “will take action at the first sign of promise for rare diseases,” but would also be “holding companies more accountable” for proving that their drugs work after approval.
Linda Marbán, CEO of Capricor Therapeutics, felt confident about the company’s chances of winning FDA approval for its cellular therapy to treat Duchenne muscular dystrophy, a rare and fatal genetic disease that mostly affects boys.
“We thought we were a slam dunk,” she said in an interview.
But on July 11, the FDA notified San Diego-based Capricor that it wouldn’t approve its therapy without additional data. Marbán was stunned. “For the first time in my life, we hired a lobbying firm,” she said, enlisting a team of more than half a dozen with ties to the GOP. “I got on an airplane and traipsed around Capitol Hill just to get our voices heard.”
Meanwhile, Prasad had long been skeptical of another gene therapy for Duchenne, Elevidys by Sarepta Therapeutics. He had criticized his predecessor Peter Marks for overruling agency reviewers who recommended against approving the drug.
In mid-July, the FDA pressured Sarepta Therapeutics to pause shipments of its gene therapy following three deaths potentially linked to the company’s medications.
“The FDA will not allow products whose harms are greater than benefits,” Prasad said in a statement at the time.
The news rocked advocates for Duchenne patients, a small but mighty constituency that went to bat for the drug’s approval.
The FDA pressure touched off an uncoordinated push by individual families “writing to the FDA and cc’ing their representatives,” said Pat Furlong, CEO of Parent Project Muscular Dystrophy.
Some Republicans took notice of the FDA’s handling of the issue. Former Republican senator Rick Santorum, who has a daughter with a genetic disorder, said on X that Prasad was “destroying @POTUS legacy for helping patients.”
In an interview, Sen. Ron Johnson (R-Wisconsin) said he relayed concerns about the pause to HHS Secretary Robert F. Kennedy Jr., Makary and Trump without calling for Prasad’s ouster.
“To me, this is a right-to-try issue,” Johnson recalled telling Makary in a phone call late last week. “These are families who are well aware of the course of their child’s illness, the risk of these therapies. They are willing to assume that risk.”
Both Johnson and Trump are champions of the “right to try” movement to allow people with life-threatening illnesses to bypass the FDA to obtain experimental medications.
The cause fits into some of the medical freedom values of Kennedy’s nascent “Make America Healthy Again” movement aimed at tackling chronic disease and childhood illness.
The FDA on Monday partially lifted the pause on Sarepta’s therapy. After Prasad’s ouster the next day, stocks of Sarepta and two other companies scrutinized by his division went up.
In a note to investment clients Wednesday about Prasad, Leerink Partners analyst Joseph Schwartz wrote, “we wonder if his departure could signal a shift towards the more permissive, patient advocacy centered ‘right to try’ wing of the MAHA movement.”
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A pressure campaign
Prasad rose in prominence for his criticism of public health officials’ approach to the pandemic. He commanded a significant following on social media, a podcast and YouTube channel. But he entered government with little experience leading federal bureaucracy, battling powerful interests in Washington or navigating the dueling factions of Trumpworld.
He had powerful allies: Makary, the FDA chief who named Prasad to his post and later expanded his role to serve as the agency’s chief medical and scientific officer, and Kennedy, who moved to undo the blanket recommendation for Americans to get coronavirus vaccines.
Others with sway in Trump circles were wary.
According to Loomer, her HHS tipster said Prasad “just constantly clashes with the Trump administration,” and described a “power struggle within HHS between the Kennedy faction and the Trump faction.”
In a statement for HHS, Nixon said the department “is fully united behind the agenda of President Trump and Secretary Kennedy to Make America Healthy Again.”
Prasad became one of the latest targets for Loomer, whose public and private criticism of several Trump administration officials have preceded their firings. Loomer’s campaign against Prasad on her website and social media highlighted his past praise for liberal presidential candidates and criticism of Trump.
Loomer said she met with Trump at the White House on July 24, but the purpose of the meeting was not to discuss Prasad. But her reporting on Prasad found its way to the president, according to two people familiar with the situation, who spoke on the condition of anonymity because they were not authorized to discuss the issue publicly.
Kennedy fought for Prasad to remain at the agency, according to three people familiar with the matter.
As part of the negotiations over Prasad, Trump officials are seriously considering launching a separate vaccine center within the FDA, according to two of the people. That was a key ask of Kennedy, who has a long history of disparaging vaccines and is now upending long-standing immunization policy. The center Prasad oversaw handles a broad range of biological products, including vaccines, cellular and gene therapies, as well as blood for transfusions. Politico first reported the potential restructure, as well as the White House’s role in Prasad’s ouster.
The prospect of a dedicated FDA center has raised questions among vaccine experts over who the secretary will seek to fill such a role and whether they would take a harder line against commonly administered shots.
For now, George Tidmarsh, who was recently tapped as the agency’s top drug regulator, is taking on Prasad’s portfolio, according to an FDA email obtained by The Post. Health experts and former FDA officials say the permanent new leader could signal how the agency will lean on approvals, vaccines and other controversial decisions.
(This article appeared on The Washington Post Syndicated Service on August 1, 2025)