Following a lobbying campaign to remove a top FDA official publicly driven by right-wing activist Laura Loomer – using his past criticisms of President Trump and self-declarations of being a progressive – Dr. Vinay Prasad resigned from his post under White House pressure. While a campaign to reinstate Prasad succeeded – including both outside advocates and top officials like FDA commissioner Dr. Marty Makary – this temporary hiatus is not a story of Prasad saying he likes Senator Bernie Sanders (I-VT). It is actually a story of decades of Big Pharma influence and the corruption of American medicine.

Serving as director of the Center for Biologic Evaluation and Research (CBER), Dr. Prasad has overseen the regulation and approval of vaccines and biologic treatments, such as gene therapies. He joined the Trump Administration’s health department headed by Robert F. Kennedy Jr as part of a rebuke of the previous public health establishment and particularly their COVID-19 pandemic policies. For example, he attacked the low-certainty evidence backing universal COVID-19 vaccine boosting which lacked data from randomized control trials (RCTs) – the gold standard form of evidence that the FDA required for the original shots – about clinical outcomes like symptomatic infection, severe illness, and death.

As CBER head, Prasad joined FDA Commissioner Dr. Marty Makary in May, announcing a risk-based approach to approving COVID-19 vaccines better reflecting the policies of peer nations. Accordingly, the FDA approved two COVID vaccines in May for seniors and people with at least one risk factor for severe COVID-19 based on weaker immune-response data while getting vaccine maker commitments to conduct RCTs on clinical outcomes for younger, healthy populations.

Prasad’s dedication to requiring companies to prove their products’ safety and effectiveness is not unique to COVID-19 vaccines. It reflects his overall position as an oncologist to avoid wasting patients’ time and money with ineffective treatments

But this approach soon ran into powerful industry opposition. In June 2024, Prasad’s predecessor, Dr. Peter Marks, overrode multiple FDA review teams to approve Sarepta Therapeutics’ gene therapy, Elevidys, to treat Duchenne muscular dystrophy (DMD). Previously, an FDA advisory committee narrowly recommended accelerated approval – a regulatory pathway that requires another trial after the product is on the market – to treat 4-5 year-old children after the drug failed to show that it improved muscle function. In its postapproval trial, Elevidys again failed to show a benefit in improving function, leading FDA reviewers to oppose fully approving the drug. 

Yet, Marks pushed the drug’s approval and expanded the eligible population from just 4-5-year-olds to everyone above the age of 4. Former FDA acting chief scientist Luciana Boro reacted, “Peter Marks makes a mockery of scientific reasoning and approval standards that have served patients well over decades … This type of action also promotes the growing mistrust in scientific institutions like the FDA.”

Since approval, three patients either receiving Elevidys or another, very similar Sarepta gene therapy died with signs of liver failure, each of them being above the age of 4. Consequently, Prasad and the FDA pushed Sarepta to stop shipping Elevidys; the company initially resisted but ultimately complied.

In response, industry supporters launched a significant campaign to oust Prasad. The Wall Street Journal ran multiple anti-Prasad pieces, citing his Elevidys decision and lambasting him as a “Bernie Sanders acolyte.” Loomer derided Prasad for sabotaging Trump’s “deregulatory agenda” and “blaming pharmaceutical companies, not the FDA, for delays in drug access.” 

Former Senator Rick Santorum attacked Prasad about Elevidys and reportedly lobbied the White House. Senator Ron Jonson (R-WI) directly alerted President Trump about his opposition to the FDA asking Sarepta to pause shipments. Right before Prasad’s forced resignation, the FDA allowed Sarepta to resume shipping the product.

While Commissioner Makary and Secretary Kennedy defended Prasad, President Trump reportedly ordered his removal. Yet less than two weeks later, Prasad rejoined the FDA after Commissioner Makary publicly stated his desire for Prasad to return, having previously called him an “impeccable scientist” and “one of the greatest scientific minds of our generation.”

While Prasad’s reinstatement shows the influence of Commissioner Makary and Secretary Kennedy on the White House, the fact he departed the agency at all from outside pressure is revealing of a larger phenomenon. The intense backlash against a regulator for asking Sarepta to stop shipping an unproven, potentially dangerous treatment is not unique – it reflects immense industry influence over the FDA over the last thirty years.

In 1992, Congress passed the Prescription Drug User Fee Act (PDUFA) which increased the FDA’s budget to increase the speed of approvals by taking money directly from drug companies. Industry funding sunsets every five years, so the agency has negotiated with drug companies about regulatory priorities to reauthorize and increase funding before every five-year congressional reauthorization. Industry funding constitutes roughly half of total FDA funding, including 70 percent of the budget for human drugs.

PDUFA reauthorizations have repeatedly reduced evidence standards, so that the FDA approves treatments with less evidence that they are safe and effective. For example, the agency has let companies increasingly rely on surrogate measures to predict clinical benefit rather than directly showing the benefit itself, like just showing a drug lowers cholesterol instead of proving it actually decreases heart attacks and strokes. Yet, several studies – some of which Dr. Prasad authored – have shown that many, even most, FDA-accepted surrogate measures have no or extremely poor evidence showing they actually predict any clinical benefit.

For every five-year period, the FDA chases performance goals that are tethered to faster review times for more approvals. The FDA lacks performance goals for quality data showing safety and effectiveness or pulling dangerous, ineffective treatments off the market. Given that several studies show majorities of new drugs are not better than existing standards of treatment, the current regulatory framework explicitly favors pharmaceutical industry profits over public health.

To get more products on the market quickly, the agency has shifted more to relying on determining safety and effectiveness after approval rather than beforehand. This comes with risks, as several studies have shown drugs approved in expedited programs have more safety issues. The FDA approved Vioxx via an expedited review program without requiring Merck to conduct proper safety trials even after heart attack concerns arose. Vioxx then killed an estimated 30-60 thousand people, and it was the manufacturer Merck, not the FDA, that ultimately pulled it from the market.

Dr. Prasad represented a rejection of inappropriately weakening standards of evidence for the sake of faster approvals and greater industry profits while giving patients’ false hope with ineffective and sometimes dangerous treatments. Catherine Collins, a mother of a son with DMD, stated that the lax regulatory framework behind DMD drugs like Elevidys “just hasn’t worked out for our community, and we’re just completely worked over by Sarepta.” The public campaign against Prasad directly cited industry priorities; Loomer chastised him for missing expedited approval deadlines under the PDUFA framework.

We do not know if President Trump and the White House were personally more swayed to initially push out Prasad because of the Sarepta case or Prasad’s previous critical statements of him. Regardless, it spawned from Dr. Prasad challenging drug companies’ stranglehold over the FDA. This saga sends both a warning and a hopeful message. On one hand, if regulators attack the pharmaceutical companies’ interests, the industry and its backers will go after them – and might cost them their jobs. On the other hand, if key administration officials fight back on behalf of those protecting the public interest, they can win.