On July 29, Dr. Vinay Prasad abruptly left his job at the U.S. Food and Drug Administration (FDA); less than two weeks later, on August 9th, he returned. It’s been a long, strange season for the director of the FDA’s Center for Biologics Evaluation and Research (CBER), who only began work at the agency in May. His brief tenure was disrupted by MAGA influencers such as Laura Loomer, who accused Prasad of being a “progressive left saboteur” bent on undermining the Trump administration. Shortly before his departure from the FDA, the Wall Street Journal editor Allysia Finley penned an op-ed calling the hematologist-oncologist “a one-man death panel.”
Finley was referring to Prasad’s immense authority over the nation’s drug market as well as his skepticism of the pharmaceutical industry and his reluctance to approve new drugs. Prasad’s return to the FDA marks a curious moment in the Make America Healthy Again movement. He has attracted great scrutiny in part because of the power he seeks to wield; in a January 2023 post from his own Substack newsletter, he begins by noting that he is a progressive who favors “a strong regulatory state” and who supports Bernie Sanders. An ardent opponent of the Trump administration’s “right to try” law, he virtually always errs on the side of granting patients fewer treatment options.
Despite being a proud progressive, Prasad found common cause among many conservatives by opposing severe Covid-19 measures, including school shutdowns and sweeping vaccine mandates. In May 2025, he published a study in the New England Journal of Medicine (co-authored by FDA commissioner Dr. Martin Makary) that proposes a nuanced Covid-19 vaccine schedule, taking things like age and underlying conditions into account. But Prasad’s skepticism of Covid-19 vaccines appears to extend to pharmaceuticals in general.
In July alone, Prasad made the news several times by scuttling treatments for rare and severe illnesses. On July 18, he halted shipments and use of Sarepta Therapeutics’ Elevidys, the sole approved gene therapy for Duchenne muscular dystrophy. In response to extreme backlash by the families and doctors of young people with Duchenne, the FDA partially reversed Prasad’s decision. Also on July 18, the FDA rejected Genentech’s postmarketing confirmatory study for its new lymphoma treatment, despite the fact that it had already been granted accelerated approval for certain advanced lymphoma patients. On July 11, the FDA rejected Ultagenyx’s new gene therapy for Sanfilippo syndrome, a fatal genetic disease that mainly affects the brain and spinal cord. And Replimune’s new therapy for advanced melanoma was denied on July 22, despite strong initial results among patients who had exhausted existing treatments.
Prasad’s unpredictable approach in reviewing treatments for rare illnesses has created turmoil in an already challenging industry. Replimune noted that the FDA’s grounds for rejection–namely, concerns with Replimune’s study design–had not been cited by the FDA at any point during mid- or late-cycle review. The FDA had in fact initially aligned with the drug company on the design of their confirmatory study. As a result, patients suffering from advanced melanoma are being prevented from accessing a promising new treatment.
Prasad’s stance on these and other drugs should not come as a surprise. In a 2021 paper about an FDA-approved cell therapy for multiple myeloma–a treatment that had reduced disease progression or death by half among patients with advanced cancers who hadn’t responded to already approved therapies–Prasad concluded that it “is crucial to question whether non-curative therapies . . . are worth it.” The therapy was expensive, he noted, and it might “only delay inevitable progression” of the disease in some patients. Of course, many medicines, from flu remedies to cancer treatments, are meant to prolong the inevitable progression of the human life cycle, which ends in death.
In a 2022 paper, Prasad estimated that patients with advanced cancers spend 16 more hours a month accessing and receiving novel treatments than if they had accepted hospice or home palliative care. “Time is a valuable resource for people who have cancer,” Prasad noted, without considering why such patients are willing to gamble to get more of it. In 2016, he published an op-ed lauding the highly restrictive approach to drug research in the United Kingdom and suggested the U.S. consider doing more to ration treatments. Here too, Prasad ignored the fact that survival rates for hard-to-treat cancers are much lower in the U.K. than in America, and that British patients often travel abroad in search of life-saving care. In these and many other instances, Prasad advises patients and drug designers simply to throw in the towel early to save us all a few bucks.
Prasad’s approach is that of the classic bureaucrat. In ignoring the wishes of struggling patients and families, and shrugging off the promises of innovation, he seeks to strip the American health system of much of what makes it great.
