Trump Taps Vinay Prasad to Oversee FDA Biotech Program

44 mins ago

3021 posts

Trump Taps Vinay Prasad to Oversee FDA Biotech Program \ Newslooks \ Washington DC \ Mary Sidiqi \ Evening Edition \ Dr. Vinay Prasad, a frequent critic of the FDA and vaccine policies, has been appointed to lead the agency’s vaccines and biotech drug program. His selection by FDA Commissioner Dr. Marty Makary marks a shift from traditional leadership and aligns with the Trump administration’s pattern of elevating medical contrarians. Prasad replaces longtime vaccine chief Dr. Peter Marks.

Quick Looks

Dr. Vinay Prasad to head FDA vaccine and biotech program, replacing longtime chief Dr. Peter Marks.
FDA Commissioner Marty Makary praised Prasad’s medical career, despite his critiques of the agency.
Prasad is known for opposing COVID-19 policies, including boosters and mandates.
His views align with other Trump-era appointees, including Robert F. Kennedy Jr. and Jay Bhattacharya.
Prasad has publicly questioned the value of the FDA, calling it unnecessary in its current form.
Drugmakers worry his leadership could disrupt predictable FDA review processes.
Marks resigned after conflicts with Health Secretary Kennedy over vaccine safety.
Prasad previously criticized FDA cancer drug approvals, citing weak evidence.
Appointment draws concern from pharmaceutical and biotech industries.
Critics say Prasad lacks expertise in infectious diseases and vaccines.

Deep Look

In a decision that’s already sending shockwaves through the biomedical industry, the Food and Drug Administration (FDA) has appointed Dr. Vinay Prasad, a prominent critic of pharmaceutical regulation and vaccine policy, to lead its Office of Vaccines and Biologics, which oversees vaccine development and biotech drug approvals. The move, announced Tuesday by FDA Commissioner Dr. Marty Makary, reflects a continued shift under President Donald Trump’s second administration toward placing outspoken skeptics of public health orthodoxy in influential federal roles.

Traditionally, this high-level FDA post has been filled by career scientists with extensive experience navigating the regulatory landscape of vaccine safety, efficacy, and approval. But Prasad—a hematologist-oncologist and academic at the University of California San Francisco—has built his public profile by challenging the very system he will now oversee.

His appointment follows the abrupt departure of Dr. Peter Marks, who resigned in March amid clashes with Health Secretary Robert F. Kennedy Jr. over vaccine safety and the future direction of the agency. In a social media post, Prasad mocked Marks, likening him to a “bobblehead doll” that rubber-stamped approvals without adequate scrutiny.

The announcement is raising alarm across the pharmaceutical and biotech industries, which depend on the FDA’s historically stable review framework to guide development strategies, regulatory filings, and investment timelines that can span decades. Prasad’s long-standing opposition to fast-track drug approvals and vaccine mandates has led many to question whether his leadership will undermine the FDA’s ability to respond swiftly to emerging health crises.

“Dr. Prasad has a long and distinguished history in medicine,” Commissioner Makary wrote in an internal agency memo. “His critical lens on health policy will help strengthen scientific rigor within the agency.”

However, critics warn that Prasad’s views have often gone beyond healthy skepticism and into territory that could destabilize public trust in the agency’s mission.

A Voice Against FDA Norms

Prasad gained national attention during the COVID-19 pandemic for his public criticisms of lockdowns, mask mandates, and the authorization of vaccine booster shots—especially in adolescents and young men. In a 2022 co-authored paper with Dr. Makary, he questioned the need for boosters in this demographic, citing the risk of vaccine-related myocarditis, a rare and typically mild inflammation of the heart. The paper concluded that the harms of booster mandates outweighed the benefits, despite strong backing from the broader public health community.

Notably, none of the authors were specialists in infectious disease or vaccine science, a fact that fueled backlash from experts and leading medical organizations.

Prasad has also been an outspoken critic of the FDA’s accelerated approval program for cancer drugs, pointing out that many treatments are greenlit based on surrogate endpoints—such as tumor shrinkage—without concrete evidence of increased survival or improved quality of life. While the agency argues this approach gives hope to terminally ill patients, Prasad contends it results in expensive therapies with questionable benefits.

His contrarian stance extends to the structure of the FDA itself. In a 2023 podcast with former GOP presidential candidate Vivek Ramaswamy, Prasad said Americans might be better off without the FDA as it currently exists.

“If you’re talking about FDA 2024,” Prasad said, “I think they’d probably be better off as a result of not having the FDA.”

Industry and Policy Repercussions

The reaction to Prasad’s appointment has been swift. Biotech executives and pharmaceutical lobbyists expressed concern that under his leadership, the predictability and transparency of the FDA’s drug and vaccine approval process could erode, leading to delays, increased costs, and regulatory uncertainty for lifesaving treatments.

His close ties to Robert F. Kennedy Jr., a longtime critic of vaccine safety standards and leader of the “Make America Healthy Again” movement, also raise red flags for public health advocates. Prasad has appeared regularly on pro-Kennedy podcasts and has echoed claims that the FDA is unduly influenced by the pharmaceutical industry—a central theme in Kennedy’s populist health agenda.

Despite these concerns, the Trump administration continues to defend the appointment as a way to reform what it sees as entrenched and unaccountable bureaucracies. Alongside figures like Makary and NIH Director Jay Bhattacharya, Prasad is part of a broader strategy to reshape federal health agencies into bodies that emphasize “individual choice” and “scientific dissent” over institutional consensus.

“The agency needs critical thinkers, not rubber stamps,” said one Trump health official. “We’re not here to repeat the mistakes of the past four years.”

Looking Ahead

It remains unclear how Prasad’s leadership will affect day-to-day operations at the FDA. His critics argue that his lack of direct experience in infectious diseases or vaccine science could slow regulatory reviews and discourage biotech innovation at a time when new therapies for cancer, COVID-19, and autoimmune diseases are entering clinical trials at record pace.

Meanwhile, supporters argue his appointment is a necessary corrective to years of perceived overreach and a pharmaceutical industry that many believe has grown too close to regulators.

One thing is clear: Prasad’s leadership marks a new era for the FDA’s vaccine and biologics division—one likely to be defined by public debate, legal challenges, and sharp divisions within both science and politics.