The FDA’s top biologics official voted for Biden and Sanders—and ridiculed Trump’s Right to Try law.
Imagine telling a poor cancer patient they can’t access the same genomic test their wealthier neighbor receives—not because it doesn’t work, not because it's unsafe, but because a bureaucratic panel has declared the science behind it “not pure enough.”
This isn’t a dystopian hypothetical. It almost happened in Oregon, where a Medicaid board nearly blocked coverage for genetic testing that could guide life-saving cancer treatment. At the helm of that chilling deliberation? Dr. Vinay Prasad.
Yes, the very same Vinay Prasad who now presides as director of the FDA’s Center for Biologics Evaluation and Research—the division responsible for approving gene therapies, stem cell treatments, and cutting-edge immunotherapies. The same Prasad who, before joining the FDA, accused the agency of using “shenanigans” to approve therapies for Duchenne muscular dystrophy (DMD)—treatments he dismissed as “useless.”
Trump and Jordan McLinn embrace, as president signs "right to try" bill May, 2018
Now, he’s the official in charge of reviewing the safety of Elevidys, Sarepta’s gene therapy for DMD.
Prasad, as chair of Oregon’s Health Technology Assessment Subcommittee, made his disdain for innovation crystal clear. “Genome-informed cancer medicine,” he wrote, “has some benefit, but is mostly hype.” That posture translated into policy. He supported what would have been the nation’s first formal move to deny Medicaid coverage for genomic testing—an act so ethically corrosive that oncologists and health equity advocates revolted.
Dr. John Stewart of the University of Illinois Cancer Center called it plainly: “This is potentially an assault on the treatment of underrepresented populations.” The draft policy was ultimately withdrawn.
Prasad’s hostility toward breakthrough therapies is not confined to policy memos. He has dismissed Elevidys as “disgusting” because of its $3.2 million price tag, decried its “unclear benefit,” and labeled it a “useless drug.” He lumped it together with Sarepta’s earlier exon-skipping therapy Exondys 51, calling its approval the result of “shenanigans” and “FDA politics” overriding science.
To Prasad, the danger isn’t a fatal disease killing your child—it’s the prospect that someone might get a new medicine he doesnt think is worth using . In 2016 he wrote: The case for rationing: Why we should limit public spending on cancer drugs.”
In this essay, Prasad made an explicit and unapologetic endorsement of rationing, arguing that public spending on cancer drugs should be subject to limits like those he used to ration genetic testing to Medicaid patients. This is not a man who sees suffering and responds with urgency. This is a man who sees urgency and responds with contempt.
Parents are seeking something more.
When families learned that access to Elevidys might be curtailed due to internal FDA dissent, the reaction was swift and anguished. “Families who have fought tirelessly for access to this therapy, those who have already received it, and those who are in line to receive it are now left with more questions than answers,” said Parent Project Muscular Dystrophy (PPMD), which demanded answers from both Sarepta and the FDA.
The Muscular Dystrophy Association echoed the pain: “These developments are painful, and they’ve shaken the hope that many families have carried for years.”
Sarepta must provide data to restore trust with patients and regulators. Normally, the company could work with with families and the FDA on resuming Elevidys distribution and enhancing future reviews.
But these are not normal circumstances.
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.
Prasad has long made clear that he would reverse what he sees as the FDA’s leniency. “Their job is the safety and efficacy of drug products,” he snapped on social media, listing Exondys, Aduhelm, and COVID boosters as examples of supposed failure. “Now they want to tweet snark?”
But families aren’t asking for snark or leniency They’re asking for the same moral urgency the Right to Try law was built upon—urgency that President Trump understood viscerally. The 2018 law wasn’t just policy; it was a declaration that in America, a desperate parent has more standing than a bureaucratic panel. That a patient facing death deserves a shot at hope—even if the clinical endpoint isn’t yet statistically significant.
Prasad rejected that vision outright. He mocked Right to Try as symbolic and insisted it had no value. And now he sits atop the very agency that Trump sought to unshackle from bureaucratic inertia.
This is no small irony, given that Prasad has become a darling of some conservative commentators. A few vaccine-hesitant soundbites and critiques of lockdowns, and suddenly he’s portrayed as a maverick ally of the populist right. But don’t be fooled.
Prasad is not a Trump Republican. He’s not even a reluctant centrist. He is a lifelong progressive who proudly supported Bernie Sanders and Joe Biden. He derided Trump as “Mr. Orange,” called 2020 election challenges “laughable and pathetic,” and supported a wealth tax, 50% marginal tax rates, student loan forgiveness, and race-based structural reform in medicine. He called Trump’s immigration policy “a human rights violation.”
This isn’t libertarian contrarianism. This is textbook academic leftism dressed in an occasional lab coat of nuance.
Even his COVID criticisms—while sometimes thoughtful—came long after the damage was done. He was “fine” with school closures and once praised Anthony Fauci as “St. Anthony.” He co-authored op-eds with Zeke Emanuel blaming Trump for hundreds of thousands of deaths. His objection wasn’t to government overreach—it was to Trump’s execution of it.
And now, families who have given everything—biological samples, years of advocacy, their children’s very bodies—are being handed back bureaucratic indifference and ideological scorn.
They deserve better. From Sarepta. From the FDA. From a system that promised them hope.
If the FDA wants to preserve its integrity, restore public confidence, and honor the spirit of the President’s Right to Try vision, then Prasad must resign—or at least recuse himself from all matters related to Sarepta and gene therapy review.
Because no one —especially one with an ideological vendetta—should have the power to ration hope.
Robert Goldberg is Vice President of The Center for Medicine in the Public Interest .
