Trumped by Pharma: How Donald Trump Was Bamboozled into Ousting FDA's Vinay Prasad

Many in the medical community were stunned when Vinay Prasad, a hematologist-oncologist and professor at the University of California, San Francisco, who has spent years ringing the alarm about the pharmaceutical industry’s grip on medicine and policy making was pushed out a short few months after his appointment to an influential role in the Trump FDA as the head of the Center for Biologics Evaluation and Research (CBER).

The anatomy of his fall raises red flags about the control pharmaceutical companies exert over the government officials that are supposed to regulate them.

Vinay Prasad: The Outspoken Critic Who Challenged Pharma and COVID Orthodoxy

Prasad was a prolific academic that has long believed the pharmaceutical industry manipulates evidence-based medicine to push drugs with shaky benefits, burdening society with exorbitant costs—a critique that set the stage for his later battles. During the COVID-19 pandemic, he noted the same shoddy level of evidence and critical thinking was deployed to support all manner of authoritarian wishes. While many of his colleagues became willing cheerleaders to a public health monolith that maintained their policies were rooted in The Science, his skepticism of these policies and regular evisceration of the major players in public health pushing these policies garnered him popular notoriety among those on the right and left who like Prasad, felt lockdowns, mask mandates, and vaccine mandates ignored trade-offs, especially for younger populations. It was this reputation as a sharp outspoken critic that caught the eye of the new members of the Trump administration who came to D.C intent on shaking up the status quo, but it also foreshadowed the storm that would force him out.

Dr. Prasad goes to Washington D.C.

In May 2025, Prasad took the helm of the FDA’s Center for Biologics Evaluation and Research (CBER), tasked with overseeing vaccines, gene therapies, and biologics—a role where his principles would face their toughest test. He hit the ground running, collaborating with FDA Commissioner Marty Makary to tighten standards, scaling back COVID booster recommendations for healthy people under 65 and mandating placebo-controlled booster vaccine trials be completed in lower risk individuals before being labeled as “safe and effective” by the FDA. He also ensured warnings for myocarditis risks in young males were added to COVID vaccines, addressing a shamefully long cover up brought to light in startling detail by Wisconsin Senator Ron Johnson. (Please see footnote per Naomi Wolf) [1]

But ultimately it was his confrontation with a relatively small biotech company — Sarepta Therapeutics — and their gene therapy Elevidys for a rare terminal muscle wasting disease that strikes 1/5000 boys that really ignited the fire. Priced at $3.2 million per patient, Elevidys had been given accelerated approval by the FDA in 2023 despite failing to meet its primary endpoint in its key trial. The very real questions of effectiveness of the therapy paled in comparison to its potential toxicities. When three patient deaths from liver failure surfaced in July 2025, Prasad had seen enough. Under his direction, the FDA asked Sarepta to voluntarily halt shipments and pause trials, citing “unreasonable risk.” Sarepta stock nose dived as investors began to take stock of the fact the company they were long on for promising break through drugs in the muscular dystrophy space may actually be worth nothing.

This wasn’t the first time Sarepta had been in the spotlight for shaky evidentiary standards.

Sarepta's Playbook: Exploiting Hope and Evading Accountability in DMD Drug Approvals

Sarepta Therapeutics, a Cambridge, Massachusetts biotech, has long exploited desperate DMD families and advocacy groups—many they help fund—to pressure the FDA for accelerated approvals based on surrogate markers like micro-dystrophin expression, and then promising follow-up studies they take a very long time to complete. At a 2024 patient conference, Catherine Collins, a DMD mom, called out this behavior, noting a pattern of getting early approval for drugs based on promising surrogates that offered glimmers of hope, but never coming through with actual follow up data to show significant improvement in important clinical endpoints.

Its fairly easy to verify Ms. Collins’ concerns by reviewing Sarepta’s controversial first drug Exondys (eteplirsen) that was approved by the FDA September 19th, 2016. This particular FDA approval was covered in great detail by a Science media that had yet to enter the phase of media life where their only mission was to make Donald Trump look bad. In brief, Sarepta applied for accelerated approval for a therapy that increased levels of the deficient dystrophin protein in boys that had a particular variant of Duchenne’s. The scientific committee at the FDA charged with making the decision reviewed the data submitted by Sarepta and found it wanting, voting 7-3 against full approval, and 7-6 against accelerated approval. They cited concerns about the poor quality data to support higher levels of dystrophin, no adequate controls, and no evidence of clinical benefit. Reviewers were troubled by the quality of the data Sarepta produced — the biopsies were of poor quality and the assay that Sarepta used to quantify protein expression ended up being debunked when subjected to independent analysis by the FDA. During the scientific meeting committee members also noted the “intense and near-incessant pressure from a large public audience” packed with patient advocates who all gave testimony in favor of approval.

Janet Woodcock, the Center director at the time, approved the drug. Extraordinarily, reviewers at the FDA responded by filing a formal complaint about Woodcock handling of the case, noting at the time that “this could be the first time a Center Director has overruled a review team on a question of whether effectiveness has been demonstrated”. The FDA commissioner at the time, Robert Califf, issued a 126 page report and acknowledged the many problems with approval based on murky data, but ultimately felt he did not have standing to overrule Woodcock. He noted that the FDA, in their approval letter, had mandated a dose finding study to assess clinical benefit at higher doses with the North Star Ambulatory Assessment as a primary endpoint, and this would answer the conclusion of the scientific committee who felt Sarepta’s drug just did not work.

Nine years later, Sarepta has had more drugs approved, and a search on clinicaltrials.gov, reveals one trial that fits the description of what the FDA mandated when it approved the drug: the MIS51ON trial (NCT03992430). The study is listed as still in progress. It was started in 2020, and expects to be completed in 2026.

And yet, Exondys as well as three other drugs are still on the market almost entirely based on higher expression of the dystrophin protein. How much benefit, or how any of these drugs alter the natural history of a terrible disease remains unclear.

You can now appreciate the frustration of parents who have been following the Sarepta like Ms. Collins. Elevidys is rinse and repeat. The message to parents is simple : A game changing new drug that increases dystrophin! Potentially life changing! And the only thing that stands in the way is those humbugs at the FDA.

Elevidys , a gene therapy delivered as a one shot using an adenoviral Adenoassociated viral vector (AAV) needed to show significant improvement in motor function as tested using the widely accepted North Star Ambulatory Assessment, but failed. It didn’t matter. FDA agency staff again recommended against approval, and this time the man in charge - Peter Marks - overrode their objections to allow the drug onto the market. The drug was initially approved for young ambulatory boys based on the trial (that failed), but amazingly in June 2024, then-CBER director Peter Marks expanded the approval for the drug to all ambulatory patients and non-ambulatory ones.

It was in this backdrop that you should be able to understand why the FDA moved swiftly when the third death associated with Sarepta’s gene therapy vector for Elevidys now made the risks of the therapy undeniable. It was one thing for the FDA to approve relatively safe drugs that didn’t work — expensive placebo’s… quite another thing to approve a therapy that may not work, and every now and then killed someone.

The toxicity should not have come as a surprise, either. It was well known that the adenoviral vector, AAVrh74, used to carry genetic material, was highly immunogenic, triggering immune responses that caused severe liver injury, requiring heavy steroids and immunosuppressive drugs like sirolimus. Highlighting the risks of Marks decision to broaden the indications for therapy based on flimsy data, two of the teens that died were older, non-ambulatory teens : the very group that was excluded from the original trial that lead to the FDA’s controversial drug approval.

The teens died of liver failure in March and June.. a third death—a 51-year-old man in a Sarepta trial using the same vector—was reported to the FDA on July 3, 2025. Sarepta knew this by their June 16th earnings call but made no mention of the newest death on the call. The Sarepta CEO, Doug Ingram, later noted that he didn't disclose the patient death on the earnings call, as "it was neither material nor central to the topics at hand".

On July 18, the FDA asked Sarepta to voluntarily halt Elevidys shipments and pause trials. Sarepta eventually capitulated on July 21, but behind the scenes a storm was brewing that eventually would take out Sarepta’s chief roadblock at the FDA.

Orchestrated Takedown: Media Strikes and Political Pressure

In the week after the FDA moved on Sarepta, a series of coordinated media strikes came out: Robert Goldberg of the pharma-backed Center for Medicine in the Public Interest slammed Prasad’s “unhinged” actions in influential publications read by many in the biotech space. Meanwhile, someone tipped right wing influencer Laura Loomer about 5 year old tweets of Prasad, painting him as a Bernie Sanders disciple that was a Trump saboteur. Parts of the Loomer report on Prasad appear to be suspiciously in sync with the usual line of attack the biotech/pharmacuetical industry typically takes.

Loomer cast Prasad’s push to improve evidentiary standards so drugs that don’t work wouldn’t hit the market as opposing Trump’s deregulation agenda. She also featured insider FDA details, with three hyperlinks to niche pharma and FDA outlets, including a Stat News link requiring a subscription. Is Laura Loomer really a regular rider of a publication that almost exclusively covers the pharmaceutical industry? The report had the desired effect of catching Donald Trump’s attention. Reporting from Stat news noted that Wisconsin congressman Ron Johnson was active talking to everyone he could about concerning actions being taken at the FDA that conflicted with right-to-try legislation he championed in Trump’s first term. He even reached out to the mom of a child with Duchenne’s who was in Washington DC for the signing of the right to try legislation. Prasad was gone a few days later.

Pharma's Power Play: Influence, Lobbying, and the Ousting of Vinay Prasad

To date, there is nothing to directly link Sarepta, or any other pharmaceutical company with the coordinated media attack and the political pressure that was brought to bear to oust Prasad, but it appears clear that there is a significant amount of influence the pharmaceutical industry exerts in Washington DC just by looking at how much money is spent, and whom it’s spent on. According to opensecrets.org, a site that tracks spending on lobbying, Sarepta spent $1 million in 2024 and has spent $580,000 in 2025 so far. The firm that has received the most recent dollars from Sarepta is the firm Michael Best & Friedrich, which counts a number of people close to Trump: Chris Lacivita for the 2024 presidential campaign co-chair, and Trump’s first white house chief of staff, Rience Priebus. Coincidentally, Michael Best & Friedrich tripled their just closed second quarter revenue bringing in close to $3.5 million.

The affair raises fresh questions about the political class and its demonstrably poor ability to remain free of influence of those with perverse motives.

• Ron Johnson, Wisconsin senator long apopleptic about the mrna covid vaccines and their potential side-effects is now responsible for advocating for an actual gene therapy agent that killed two teenagers and may not even work.

• Laura Loomer was “tipped” to push out an “investigative report” that lead to the firing of one of the loudest, and most vocal critics of the Left’s authoritarian COVID policies.

• Donald Trump, the president who spends much of his time talking about unilateral price reductions by pharmaceutical companies in the United States forced out one of the more competent individuals at the FDA because he stood in the way of a $3.2million gene therapy drug that may not work, and is responsible for the death of two teenagers.

The story also points to the almost complete failure of the news media that invariably paints the story as a story of a firebrand who moved too fast that just wasn’t a good fit. But Prasad wasn’t taken down by an endless parade of internal leaks, or an inability to do his job, he was forced out because he was too good at doing his job. Lost in all this was Prasad’s early moves that signaled a departure from a strict evidentiary standard in the setting of rare diseases, and his public overtures to the challenges faced by the cell and gene therapy community.

Unfortunately, it has become too much to expect extreme levels of competence from much of the federal bureaucracy. Prasad’s journey indicates the federal bureaucracy exists to serve itself and its masters — lobbyists, and industry seeking special favors from government to tip the scales in their favor so that their investors can buy bigger yachts. Try to get in the way of these interests to gum up the pharmaceutical wealth extraction scheme that rewards companies that grease the most palms in Washington DC rather than those that deliver actual value?

You’re gone.

Anish Koka is a cardiologist in Philadelphia. He writes about health policy, and co-hosts a podcast called the Doctor’s Lounge. Follow him on X Anish Koka MD (Cardiology)

Footnote/Corrections :

1. Per Naomi Wolf: Dr Koka, please issue a correction to your otherwise very interesting piece. Sen Ron Johnson did not expose the coverup of myocarditis. My team of researchers, the WatRoom/DailyClout Pfizer Documents Research team did so, via FOIA, in essays published in DailyClout, in 2023. We gave Sen Johnson the material, that he failed correctly to credit. Please credit the authors.