By Jessica Karins, Maaisha Osman, and Luke Zarzecki, July 29, 2025
Top FDA official Vinay Prasad abruptly resigned late Tuesday just months after joining the agency and being rapidly promoted to an unprecedented role as chief medical and scientific officer in addition to biologics chief. The departure, coming after a flip flop Monday by FDA to resume availability of Sarepta’s gene therapies after Prasad had cut off access following patient deaths signals a rift within HHS and factions of the Make America Healthy Again movement over medical product regulation that could prove a central issue for the administration.
A longtime right-to-try advocate who blasted the biologic center’s initial decision to take the products off the market praised the reported resignation and called for an investigation of Prasad’s handling of the Sarepta issue.
A former FDA staffer framed Prasad’s departure as part of a broader pattern of erratic, loyalty‑driven leadership at HHS, where deviation from the administration’s agenda apparently carries no second chances. Industry insiders tell Inside Health Policy the decision may have originated at the White House, underscoring the political stakes behind agency personnel changes.
HHS has not provided an explanation for Prasad’s departure. “Dr. Prasad did not want to be a distraction to the great work of the FDA in the Trump administration and has decided to return to California and spend more time with his family,” HHS spokesperson Andrew Nixon told IHP. “We thank him for his service and the many important reforms he was able to achieve in his time at FDA.”
While it’s unclear what specifically led to Prasad’s decision to leave FDA, the Sarepta saga underlines the tug of war between MAHA supporters who want deeper scrutiny of FDA-approved products and right-to-try advocates who want FDA to make products immediately available to desperate patients — represented by HHS Secretary Robert F. Kennedy Jr. and Deputy Secretary Jim O’Neill respectively. Prasad has sided with Kennedy and FDA Commissioner Marty Makary in calling for tougher approval standards, at least for vaccines.
Prasad became a center of controversy as gene therapy company Sarepta Therapeutics reported deaths associated with its treatments for muscular dystrophy, treatments that Prasad had opposed as a fiery critic of FDA regulation before joining the agency himself.
[….] FDA requested Sarepta pause shipments of its gene therapy Elevidys for Duchenne’s muscular dystrophy (DMD) after the deaths of two patients. The company initially resisted but agreed to pause U.S. shipments July 21.
Then, FDA abruptly reversed course Monday (July 28) and recommended removal of the voluntary hold.
Prasad was a high-profile critic of his predecessor Peter Marks’ decision to approve Sarepta’s Duchenne muscular dystrophy drug Elevidys, arguing the treatment showed too little benefit in clinical trials to warrant FDA clearance. Marks overruled FDA reviewers’ recommendation when he approved the drug. Prasad said on social media in March of this year that Marks “approved gene therapy that doesn’t work but kills kids (with) DMD.”
Robert Goldberg, vice president of the Center for Medicine in the Public Interest, came out harshly against Prasad’s initial decision on Sarepta, writing, “The problem is Vinay Prasad — who has made no secret of his contempt for Sarepta, dismissed DMD therapies as fraudulent, and cloaked his ideological hostility to Trump-era reform in the language of ‘science’ — now presides over these life-and-death decisions once again it seems, as a one-man death panel.”
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Goldberg’s organization, the Center for Medicine in the Public Interest (CMPI), was founded with support from the free market think tank Pacific Research Institute and has also received funding from the drug industry.
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The Sarepta controversy very quickly made Prasad into a target of conservative criticism, along with attacks from Laura Loomer, a far-right influencer and close ally of Trump who attacked Prasad as a “leftist saboteur” over comments he made prior to joining FDA.
“Known for his provocative commentary on podcasts and public platforms, Prasad’s vehement opposition to Trump and his supporters, whom he has likened to a ‘cult’ and compared to ‘criminals,’ raises questions about potential bias in his role at the FDA, particularly his opposition to the Right to Try Act — a signature Trump policy aimed at aiding terminally ill patients,” Loomer wrote on her website Monday.
While Loomer kicked off the issue, the far more mainstream Wall Street Journal editorial board, over the weekend, joined in on the anti-Prasad viewpoint. The board wrote that FDA’s action against Sarepta wasn’t “about whether the safety risks in gene therapies can be managed. It’s a claim that the drug is an expensive false hope for desperate families who Dr. Prasad thinks can’t be trusted to make their own decisions about risks and benefits. That paternalism is familiar from Democratic administrations and the FDA bureaucracy.”
“The stakes here for drug development are enormous if Mr. Trump’s regulators crush a drug that has already won FDA approval. Several early gene therapies aren’t home runs, but drug development is iterative and builds on trial and error. Forget about better drug iterations if the agency kills a company for an emerging safety warning in some patients,” the board wrote.
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Makary expressed ongoing support for Prasad as recently as this weekend. In an interview with Politico, he said there was “not a political bone to [Prasad’s] body. He’s an impeccable scientist — I think one of the greatest scientific minds of our generation.”
Meanwhile, an HHS guidance on allowing investigational drugs to be made available to patients is now pending at the White House.
Diana Zuckerman, president of the National Center for Health Research, told Inside Health Policy Prasad “strongly believed” his decision to limit Elevidys to younger boys was rooted in scientific evidence, but it was overturned after pushback from Loomer, The Wall Street Journal, and possibly O’Neill, a longtime critic of FDA’s evidentiary standards.
Zuckerman warned that FDA’s credibility is on the line and said even former biologics center Director Peter Marks — who greenlit broader access to Elevidys last year — has since walked back that call. “In retrospect,” she said, “even Marks admitted the decision to allow Elevidys use in older boys ‘probably went too far.’” She said Prasad’s exit signals the growing difficulty of “standing up for science when families are desperate for hope.”
“If FDA doesn’t demand better evidence for Elevidys, especially for boys over 5, it would be a travesty,” she said. “Either the FDA or Congress must require that the data be made public. Because right now, all we know is that the strongest evidence of benefit was in 4- and 5-year-old boys–and Vinay Prasad leaving is not going to help FDA’s already tarnished reputation.”