The MAHA Movement and Lessons of a Forced Resignation
Dr. Vinay Prasad’s abrupt resignation from the FDA wasn’t just a bureaucratic shakeup—it was a warning.
I’ve been waiting for the right moment to write more about the Make America Healthy Again (MAHA) movement—something of a calm spell between the political tides, where a conversation like this might land with more clarity than controversy. Unfortunately, a recent forced resignation from the FDA has shown me the folly of that cautious approach. It’s time to dive into the tumultuous waters now and worry about catching up on other issues and broader themes later.
Dr. Vinay Prasad is a well-respected hematologist-oncologist and tenured professor at the University of California, San Francisco who I’ve been following for a number of years. In May, he was appointed Director of the FDA’s Center for Biologics Evaluation and Research (CBER), and a few months later was elevated to a new agency-wide role as Chief Medical and Science Officer. He was an inspired choice for both positions—not only because of his clinical expertise, but also because of his principled critiques of low-quality evidence, performative science, and industry bias.
Despite continued support from Health and Human Services Secretary Robert F. Kennedy Jr., Dr. Prasad resigned from both roles at the FDA yesterday. According to reports, his resignation was not entirely voluntary, but driven by coordinated pressure from political and industry actors. Chief among them was conservative activist Laura Loomer, who absurdly labeled him a “progressive leftist saboteur” of the MAHA movement, and former Republican Senator Rick Santorum, who referred to him as “the man destroying @POTUS legacy for helping patients.”
The purported reasons for these attacks are baffling. Long before his FDA appointment, Dr. Prasad had been critical of COVID lockdowns, mask mandates, and vaccine mandates—positions I also held. Since his appointment, the FDA has modified its COVID vaccine guidance, limiting recommendations primarily to older adults and those with serious health conditions, which I believe is a wise and overdue correction. Perhaps more immediately relevant to his resignation, Dr. Prasad has consistently questioned drug approvals that rely on poor evidence—something I view not as obstruction, but as prudence.
Oddly, the decisions most proximate to Dr. Prasad’s departure both involved treatments for a rare neuromuscular disease, Duchenne muscular dystrophy (DMD). Earlier this month, the FDA rejected an application by Capricor Therapeutics for a biologic called Deramiocel, which consists of progenitor cells derived from donor hearts. That decision was sound: the initial study was poorly designed, underpowered, and failed to demonstrate either efficacy or safety. Importantly, the therapy was not shelved entirely—the FDA simply requested additional data.
Just a week later, the FDA formally asked Sarepta Therapeutics to pause all shipments of their gene therapy drug, Elevidys, amid safety concerns. In June 2023, the FDA had granted limited accelerated approval of Elevidys, despite a lack of evidence of clinical improvement (for those checking my work: the drug showed some benefit on secondary endpoints, but not on its primary one—but that’s a discussion for another time). Since then, despite ongoing study, clear clinical benefit remains elusive. Reports of adverse events—including several deaths—prompted the FDA to request the pause. Shipments were partially resumed on Monday, the day before Dr. Prasad’s resignation
.There are two ways one might view the FDA’s role in regulating pharmaceuticals, biologics, and medical devices. One view holds that the agency is unnecessary—that companies should be free to develop and market their products directly to patients, without regulatory interference. This is a libertarian view which I sympathize with, but think unwise. The other view, which I share, is that regulatory oversight is essential—but only if it is applied rigorously, transparently, and grounded in evidence. Today, we seem to have the worst of both worlds: an agency that postures as rigorous while quietly succumbing to political influence and industry capture.
The FDA, in this case, functioned less as an arbiter of evidence than as a pressure valve—venting public criticism, absorbing industry demands, and ultimately ejecting someone who insisted on applying the same standards across the board. That’s not reform; it’s regression. And it sends a chilling message to others who might try to bring integrity back to the regulatory space: you will not be protected, even if you’re right.
It’s also worth noting who replaced Dr. Prasad—at least in the interim. Dr. George Tidmarsh, now acting director of CBER, is a physician and researcher with an impressive résumé—but also a long career as a biotech executive. He helped bring multiple drugs to market as CEO or founder of companies like Threshold Pharmaceuticals and Horizon Pharma. His appointment, coming immediately after the forced resignation of a regulator known for challenging weak evidence and resisting pressure, suggests a sharp return to business as usual. That’s not a judgment on Tidmarsh personally, but it’s hard to ignore the optics—or the implications for the future of reform.
For the MAHA movement, this is a clarifying moment. It exposes the limits of trying to change institutions from within—at least without sustained public support. It also underscores the importance of building parallel sources of accountability: independent watchdogs, transparent evidence reviews, and public forums where dissent isn’t just tolerated but welcomed. MAHA was never going to be transformative overnight. But if it’s going to grow, it needs to show that what happened to Dr. Prasad wasn’t the end of something—it was the beginning of a much larger reckoning.