Critic of drug industry and COVID-19 measures to lead FDA vaccine program

WASHINGTON (AP) — Dr. Vinay Prasad, a prominent critic of the pharmaceutical industry and the Food and Drug Administration, has been named to oversee the agency’s program for vaccines and biotech drugs.

FDA Commissioner Dr. Marty Makary announced the appointment Tuesday in a message to agency staff, praising Prasad's “long and distinguished history in medicine.”

Prasad is the latest in a series of medical contrarians and critics of COVID-19 measures to join the federal government under President Donald Trump.

Unlike political roles such as FDA commissioner, the job Prasad is stepping into has traditionally been held by an FDA career scientist. His appointment raises new questions about whether vaccines and other new therapies will face unnecessary scrutiny from regulators.

Prasad replaces Dr. Peter Marks, FDA’s longtime vaccine chief who resigned in March after clashing with Health Secretary Robert F. Kennedy Jr. over concerns about the safety of vaccinations.

In a social media post, Prasad likened Marks to “a bobblehead doll that just stamps approval."

Last year, he told former Republican presidential candidate Vivek Ramaswamy that Americans would probably be better off without the FDA in its current form.

“If you’re talking about FDA 2024, I think they’d probably be better off as a result of not having the FDA” Prasad said during an appearance on Ramaswamy's podcast.

A professor at the University of California San Francisco, Prasad's medical training is in cancer and blood disorders. He first came to prominence among academics more than a decade ago for a series of papers scrutinizing the evidence behind new cancer therapies.

Research by Prasad and his colleagues showed that many cancer drugs fast-tracked by the FDA have never been shown to improve or extend patient lives. Instead, the drugs are often approved based on alternate measures, such as the ability to shrink tumors, which are thought to predict long-term survival in patients.

The FDA has long defended this practice as a way of accelerating approval of medicines for gravely ill patients.

During the COVID-19 pandemic, Prasad reached a much broader audience as a critic of vaccine and mask mandates, lockdowns and moves to speed the availability of booster shots from Pfizer and Moderna. Many of his views mirror those of other Trump appointees, including Makary and National Institutes of Health Director Jay Bhattacharya.

In 2022, Prasad and Makary were co-authors on a paper attacking the recommendation for booster shots in teens and young adults, particularly boys and young men. Those patients received particular attention because early vaccinations showed a higher rate of myocarditis, a rare form of heart inflammation that is usually mild.

The paper concluded that requiring booster shots in young people would cause more injury than benefit. None of the authors specialized in studying infectious diseases or vaccine reactions, prompting pushback from many health experts.

Angela Rasmussen, a virus expert at the University of Saskatchewan in Canada, said Tuesday's announcement “bodes extremely poorly for vaccine approvals in the U.S.”

“This decision will invariably result in decreased vaccine access for the public, less transparency, and fewer approvals,” Rasmussen wrote in an email.

In recent years, Prasad became a regular on podcasts associated with Kennedy’s “Make America Healthy Again” movement, which often portrays the FDA as beholden to the pharmaceutical industry.

Prasad's appointment is likely to rattle drug and vaccine makers, who depend on the predictability of FDA standards and procedures to guide drug development plans that can span years or even decades.

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Associated Press writer JoNel Aleccia contributed to this story.

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