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May 7th, 2025
FDA’s Latest Appointment Is … Interesting
Those of us who follow infectious diseases and vaccine science closely (OK, obsessively) know that the FDA’s Center for Biologics Evaluation and Research (CBER) plays an enormous role in public health. Vaccines, gene therapies, monoclonal antibodies, blood products — all pass through CBER on their path to approval. During the COVID-19 pandemic, this center became a household name under the steady leadership of Dr. Peter Marks, who has long championed rigorous scientific review combined with clear communication to the public.
Now comes news of a major change. Dr. Vinay Prasad, a highly visible (and often polarizing) physician, scientist, and commentator on medical evidence, has been appointed to lead CBER.
To call this appointment interesting barely scratches the surface.
I first learned about Vinay through his social media activity on what was once called Twitter, may it R.I.P. His attention-getting posts on COVID-19 reflected someone brilliant, analytically rigorous, prolific, and passionate about improving the way we generate and apply medical evidence.
When the RECOVERY trial released data showing dexamethasone’s survival benefit, and the investigators made the protocol immediately available, he urged us to adopt the findings right away — not to wait for the (inevitably slower) publication.
He loudly and repeatedly criticized prolonged school closings, correctly identifying that vulnerable populations — kids attending public schools, especially those from less affluent families — would bear the brunt of the delays in learning and social development.
He also flagged with alarm the rare but serious clotting side effects of the Johnson & Johnson and AstraZeneca COVID vaccines, issues that ultimately contributed to their withdrawal.
And he pressed for better evidence on community masking mandates. He found the data wanting — and let’s face it, masking (especially outdoors) eventually became more a political signal than a meaningful infection control strategy.
So persuasive was Vinay on these and other issues that I invited him on the Open Forum Infectious Diseases podcast, where he gave what one colleague described as a “hyper-caffeinated” take on the pandemic. No one has come close to his words-per-minute record. A high bar!
In short, he has made a career challenging dogma and questioning medical practices that are adopted with too little critical scrutiny. These qualities — intellectual sharpness, a relentless drive to improve science — will serve him well in this important job.
But there’s another side.
Vinay also embraces a confrontational style, especially in public forums. His sharp critiques can sometimes alienate as much as they illuminate. And in the nuanced and emotionally charged world of vaccine policy, that carries obvious risks. Vaccines aren’t just scientific products aiming to improve health anymore — wouldn’t that be nice? They’ve become flashpoints in public trust, political identity, and social discourse. Navigating this terrain requires careful engagement, deep listening, and collaboration with a wide range of stakeholders.
While I respect Vinay’s formidable intellect, I hope he brings his best and most collaborative self to CBER. We need a leader who values respectful dialogue, embraces uncertainty when necessary, and sees scientific regulation as a team sport — and not a zero-sum game or a chance to attack others.
For context, I also know Peter Marks and respect him enormously. He shepherded CBER through COVID-19 with grace and steadiness, during a time of tremendous uncertainty and societal anxiety, and often under intense political pressure. I am especially concerned about the reasons he has given for departure, which likely reflect growing tensions within HHS and a troubling and stubborn anti-vaccine sentiment at high levels.
Ultimately, my deepest hope — and I suspect everyone’s — is that this appointment of Dr. Vinay Prasad leads to a continued focus on improving the safety, efficacy, and public trust in biologics, especially vaccines. We need rigorous science, honest communication, and thoughtful leadership more than ever.
Before publishing this, I plan to share the post with both Peter and Vinay — partly as a courtesy, but also because I believe that transparent and respectful dialogue starts with how we talk about each other.
The stakes, after all, could not be higher.
10 Responses to “FDA’s Latest Appointment Is … Interesting”
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Paul E. Sax, MD
Contributing Editor
NEJM Journal Watch
Infectious Diseases
Biography | Disclosures | Summaries
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I have listened to Dr. Prasad on podcasts with Dr. Zubin Damania (ZDogg MD) for several years. I have always felt he was very evidenced based and as a front line practitioner who leads a hospital department I have always felt he was both fair and for the most part represented the way I felt about many topics. Hoping him nothing but the best, and after listening to him for years I feel he will be a voice of reason when we have others in positions of leadership touting dangerous unscientific opinions on certain topics. (i.e. Kennedy, I agree with some of his sentiments on topics like the importance of nutrition but he needs to give up this skepticism of the MMR vaccine and feeling that it causes autism)
“Vaccines…They’ve become flashpoints in public trust, political identity, and social discourse.” So well put. Hopefully, Dr. Prasad can help bring this topic back to the center. He is a brilliant physician and policy expert, so I feel he has the potential to do great things for the FDA. If he can only channel his brilliance and leave out the “podcast” vitriol. I think he can.
Thanks for respectfully sharing your high-level perspective openly with us and Drs. Prasad and Marks.
I have followed Dr. Prasad throughout the pandemic and been impressed by his insights into the folly and errors made by the public health establishment. I look forward to him bringing his keen intellect, understanding of EBM, and rigorous skepticism to the FDA. The agency is fortunate to have someone of his talent. I predict he will have a lasting positive influence on CBER and US public health. We in the “medical establishment” need to be open-minded and humble and embrace the kind of change that Drs. Makary and Prasad are trying to bring to our field.
I agree, Dr. Marine.
I have followed Dr. Prasad since Elon Musk/X took over the censored Twitter platform, where his and other voices of highly qualified, physician scientists such as Dr. Bhattacharya, Dr. Scott Atlas, Dr. Aaron Kheriaty and others had been minimized and outright censored.
The Twitter Files reporters told us the clear, well-documented story of the US Executive Branch and academia’s role in that censorship, aimed at views that differed from the official US government preferred narrative. Scientific debate and critical thinking were effectively diminished with resultant harms, including medical, socioeconomic, developmental, educational.
I welcomed the return of these voices, as I had wondered why there was no public debate about the COVID-19 policies, unlike any previous pandemic in my 30 year career as an ID physician. IDSA continued to simply parrot the CDC’s recommendations, leading to my resignation from that organization after expressing my deep concerns in writing and receiving no response, after 30+ years of membership and a career spanning clinical practice, public health and drug development as a drug safety, benefit/risk physician.
Dr. Marks allowed the COVID-19 mRNA vaccine makers to miss their deadlines for post-EUA safety study commitments by many months, now years. Critical interim data from those uncompleted studies was not communicated to physicians or the public.
Dr. Marks also pushed further authorizations and approvals of the mRNA vaccines for infants and children, and for subsequent versions of these vaccines, based on no placebo controlled, randomized trials, with no clinical efficacy data, and with vastly inadequate safety data. Hence, we didn’t have the data necessary to guide physicians in assessing benefit/risk, and in counseling patients to allow their true informed consent.
I’m delighted to see Dr. Prasad in this role. I have read his writings and listened to his presentations with interest. I appreciate his medical and regulatory science expertise and insights, and his attention to medical ethics.
Thank you for this information, Paul.
Is he a thoughtful skeptic or a nihilistic, contrarian provocateur? Or both?
He has a communication style that may not be well suited to a leadership role. My biggest concern is related to why he was appointed, particularly when you consider Trump’s health appointments, most notably Atlas and Kennedy (though there are other rogues in that gallery). Since reducing vaccine use is a longstanding goal of the Secretary of HHS, I fear that the choice of Dr. Prasad may be intended to move that agenda forward, perhaps by requiring for approval a level of proof unobtainable in ethical and practical clinical trials.
I am cautiously pessimistic. I hope he proves me wrong.
“cautiously pessimistic.” Never heard or read that before. ¡Me gusta mucho!
Excellent blog on NEJM Journal Watch. I’m guessing Vinjay’s confrontational style is what attracts him to the Trump administration. At least, to your point, he will bring actual science into his service.
Someone as smart as Dr. Prasad needs to learn from experts about better communication skills as he needs to communicate with aplomb not anger and disrespect for other views. Shall we say he needs to reach an emotional maturity that follows his intellectual talent. He will accomplish more and will win more proponents for reasonable vaccine coverage with a different approach.