Vinay Prasad, a MAHA-aligned hematologist-oncologist with an avid cyber following, was named director of the FDA Center for Biologics Evaluation and Research, where he will be responsible for the agency’s regulation of vaccines and biologics, including cell and gene therapies.
Prasad, who was most recently a professor of epidemiology at the University of California, San Francisco, is perhaps best known for his combative social media presence and criticisms of the mainstream medical community—particularly FDA.
During the COVID-19 pandemic, he became a vocal critic of public health responses, such as masking and vaccine mandates, and at one point compared pandemic restrictions to events in Nazi Germany (The Cancer Letter, Oct. 8, 2021).
In November 2024, the day after the election, Prasad wrote in a post on his diary-esque Substack called “Vinay Prasad’s Observations and Thoughts”: “The FDA is a failure. It rubber stamps too many useless products. It needs to either remove itself from the picture, or demand randomized trials measuring appropriate endpoints.”
Trump-allied appointees for the Department of Health and Human Services all seem to have this in common: a disdain for the agency which they have now been appointed to lead.
Jayanta Bhattacharya, the NIH director, has criticized NIH for destroying scientific authority due to the agency’s mishandling of the pandemic (The Cancer Letter, April 04, 2024). FDA Commissioner Marty Makary similarly criticized FDA for its pandemic lockdowns, and said the agency “lied to the American people” about the need for boosters and other COVID measures. Prominent vaccine skeptic Robert F. Kennedy Jr., who took the helm of HHS in February, has criticized the organization for being a “wasteful and inefficient” bureaucracy and has initiated mass firings across all its agencies (The Cancer Letter, March 28, 2025).
Prasad’s nomination comes approximately one month after his predecessor’s controversial departure. Peter Marks, the former CBER director, turned in his resignation in late March after butting heads with Kennedy on the subject of vaccines.
In his resignation letter, Marks wrote that “truth and transparency are not desired by the Secretary, but rather he wishes subservient confirmation of his misinformation and lies.”
After Marks’s ouster, Prasad wrote on X that “you could replace Peter Marks with a bobblehead doll that just stamps approval and you would have the same outcome at FDA with lower administrative fees. Maybe something DOGE should consider.”
Prasad also wrote that Marks was “the best ally of Pharma! He did more for Sarepta than the CEO… He did kill that boy with Duchesne’s [sic] but Sarepta still profits.”
Prasad’s post seems to reference the recent death of a 16-year-old boy who received the Sarepta Therapeutics Duchenne muscular dystrophy gene therapy Elevidys (delandistrogene moxeparvovec-rokl).
The therapy received an accelerated approval in 2023 based on biomarker data indicating increased microdystrophin protein expression. Marks had reportedly advocated for convening an FDA advisory committee to evaluate Elevidys’ risk-benefit profile before a final decision was reached. This was relevant, because FDA scientists initially favored rejecting the treatment, and Marks later overrode their recommendation, granting accelerated approval.
Prasad is a longstanding critic of Elevidy’ s approval. His nomination coincided with a sharp market reaction—Sarepta’s stock dropped more than 26% on May 6.
Prasad’s concerns extend beyond this specific case. He has been a vocal opponent of FDA’s use of the accelerated approval pathway, which allows drugs to reach patients based on impact on intermediate endpoints.
The accelerated pathway is widely used in oncology, where sponsors are required to prove patient benefit. In fact, the FDA Oncology Center of Excellence now wants confirmatory trials to be ongoing at a time an accelerated approval is granted.
Prasad has not responded to a request for an interview with The Cancer Letter.
A warm welcome
Announcing Prasad’s appointment, FDA Commissioner Marty Makary wrote on X that “Prasad brings the kind of scientific rigor, independence, and transparency we need at CBER—a significant step forward.”
To FDA staff, Makary wrote an email introducing Prasad’s appointment at CBER.
The internal email reads:
Dear Colleagues,
I am pleased to inform you of the appointment of Vinayak “Vinay” Kashyap Prasad, M.D., M.P.H., as the new director of the Center for Biologics Evaluation and Research (CBER).
Dr. Prasad, whose specialty is hematology and oncology, has a long and distinguished history in medicine, having worked in a variety of public scientific, medical, and academic institutions at both the federal and state level. He comes to the FDA from The University of California at San Francisco, where he has served since 2020 as a professor in the Department of Epidemiology and Biostatistics.
Before that, Dr. Prasad was a Professor of Medicine in the Division of Medical Oncology and the Department of Public Health and Preventive Medicine at Oregon Health & Science University.
Before entering academia, Dr. Prasad worked at the National Cancer Institute, where he completed a Fellowship in Cancer Prevention, and concurrently was a Fellow in Hematology and Oncology at the National Institutes of Health.
Dr. Prasad has published more than 500 academic articles, done extensive research in the field of oncology and has presented at hundreds of scientific and medical conferences. He is also the author of the books, “Malignant: How Bad Policy and Bad Evidence Harm People with Cancer” and “Ending Medical Reversal: Improving Outcomes, Saving Lives.”
He also hosted the oncology podcast Plenary Session and ran The Drug Development Letter.
Dr. Prasad graduated from Michigan State University with a B.S. in Physiology and Philosophy. He received his M.D. from the University of Chicago Division of Biological Sciences Pritzker School of Medicine, with an Internship and Residency in Internal Medicine at Northwestern University, and a Masters Degree in Public Health from the Johns Hopkins University Bloomberg School of Public Health.
He brings a great set of skills, energy, and competence to the FDA, and I know that he is eager to begin immersing himself in the important work of CBER and the agency as a whole.
I want to thank Scott Steele for serving as Acting Director of CBER. Scott will continue to work to ensure a smooth transition in leadership and will resume his previous position in CBER as Senior Advisor for Translational Science.
I hope you will join me in congratulating Dr. Prasad on his selection to this important post and thanking Dr. Steele for his excellent work as Acting Director.
Sincerely,
Marty
Martin A. Makary, M.D., M.P.H.
Commissioner of Food and Drugs
Cyber-contrarian
People pursuing government roles usually play it safe when it comes to what they say in public.
Not Vinay Prasad.
He has never shied away from speaking his mind—whether in academic papers, on YouTube, or his Substack.
With 312.7k followers and 50.3k posts under the handle @VPrasadMDMPH, Prasad is a veteran of countless X debates.
He is also known for his aggressive “blocking” on social media of people who disagree with him. In fact he blocks with such frequency that at the height of the pandemic there was a hashtag: #blockedbyvinay.
A following of such magnitude means that Prasad can easily disseminate and amplify his academic publications when they appear in peer-reviewed journals, turning otherwise obscure papers into social media hits.
Looking over Prasad’s readily accessible views on media platforms may provide insight into how he might approach his new tenure as CBER director.
In 2018, The Cancer Letter spoke to Prasad about his vocal criticism of new directions in oncology and his rise to X (Twitter at the time) stardom (The Cancer Letter, June 22, 2018).
“Let’s be honest, why do I use Twitter? Number one, I find it fun. I find it fun to use Twitter, it’s enjoyable, it’s interactive, you get to hear from interesting people,” Prasad said to The Cancer Letter at the time.
Prasad seemed to retire his Twitter/X account in 2018 (The Cancer Letter, Sept. 7, 2018), but has been active on it again up until his nomination to CBER, with his most recent post on May 4 directing his followers to his publications.
Now, his X biography reads: “inactive acct due to govt service.”
Prasad is also outspoken about his political alliances. Back in November 2024, Prasad responded on X to White House Covid advisor Ashish Jha’s “God gave us two arms for flu shot and Covid booster” with an analogy of his own:
“Ashish Jha should remember that God gave people two arms… One to vote for Donald Trump, and the other one to give thumbs up to RFK Jr.”
On his Substack, which has over 62,000 followers, Prasad posts his views on a broad spectrum of topics—from the COVID-19 vaccine for children to his most recent post, a review of Wim Wender’s film Perfect Days.
Prasad’s Substack subscription costs a minimum of $70 a year per paid subscriber.
While Substack doesn’t publicly display exact paid subscriber counts, a rough estimate can be found by observing the colored checkmark badges on the Substack profile—Prasad has an orange checkmark, indicating thousands.
Prasad has frequently expressed contempt for healthcare journalists, FDA, and CDC.
A sampling of recent headlines include: “3 ways the media coverage of health care is dishonest;” “Kennedy might pull the COVID shot for kids: Good!!!;” and “The same media that lied about all things COVID is lying about Peter Marks’ departure from FDA.”
While Prasad is now apparently off X, it’s unclear whether, under government ethics rules, he would be allowed to continue his postings on Substack.
During the pandemic, Prasad argued that public health measures may have laid the groundwork for the onset of fascism in the U.S. (The Cancer Letter, Oct. 8, 2021).
Prasad speculated that in the name of public health and safety, an unscrupulous U.S. government could turn fascist.
“When democratically elected systems transform into totalitarian regimes, the transition is subtle, stepwise, and involves a combination of pre-planned as well as serendipitous events,” Prasad wrote. “Indeed, this was the case with Germany in the years 1929-1939, where Hitler was given a chance at governing, the president subsequently died, a key general resigned after a scandal and the pathway to the Fuhrer was inevitable.”
In response to his comments and comparisons, Arthur L. Caplan, then Drs. William F. and Virginia Connolly Mitty Professor and founding head of the Division of Medical Ethics at NYU Grossman School of Medicine, wrote a guest editorial calling Prasad’s Nazi analogies “egregious” and “unnecessary” (The Cancer Letter, Oct. 8, 2021).
“You don’t need to go down that road to make points,” Caplan said. “If you think current public health efforts are overbearing or intrude too much on individual rights, what takes you from that position to allege that the next thing we’re going to see is a public health movement worldwide under the banner of fascism?”
Prasad on drug approval pathways
In his new job, Prasad may be able to reshape the landscape for biotech and biopharma.
His philosophy, laid out in a prolific number of peer-reviewed papers from his professorships—as well as on social media—is likely to have a profound influence on the standards by which CBER evaluates and approves new medicines.
“A longtime critic of FDA policies and an outspoken voice from UCSF on drug approvals and regulatory standards, Prasad is anything but a status quo appointment,” Audrey Greenberg, an executive with experience in the cell and gene therapy space, wrote on LinkedIn.
“Some will cheer his focus on data rigor and skepticism of accelerated pathways. Others will worry about delays and roadblocks in advancing urgently needed therapies,” Greenberg wrote. “What’s clear is that [Prasad’s] appointment will force tough conversations about standards, speed, and how we balance urgency with rigor.”
In a conversation with The Cancer Letter in 2018 (The Cancer Letter, June 22, 2018), Prasad said that intermediate endpoints are overused by FDA:
I believe that surrogate endpoints can be used to approve new drugs. In fact, I have a paper called, it’s an open access paper, it’s published in BMC Medicine, and it’s with Robert Kemp is the first author.
It’s called “When Should Surrogate Endpoints be Used for Drug Approval and are They Currently Overused?” In my paper, we argue that we believe that they can be used, and they should be used for drug approval, under certain circumstances, as accelerated approval, with a post-marketing commitment for at least one trial that measures survival and quality of life—in most cases.
We also say the FDA is currently using them too much. I think the nuance here is that it would be easy to say, and incorrect, that I have asked for two trials in all cases prior to approval, that’s wrong.
What I’m saying is they are currently overusing surrogates. They’re using surrogate for regular approval, where there are no post-marketing commitments, which I believe is a dangerous precedent, especially when those surrogates are unvalidated, and a paper with Chul Kim and I in the Mayo Clinic Proceedings shows are about a third of the case.
That they are unvalidated surrogates used for full regulatory approval with no postmarketing commitment, and I disagree with that.
But I do believe surrogates can be used for accelerated approval in certain instances, with post-marketing commitment.
I think the only thing I would say strongly is that, in the current world, in a paper we showed, of the 36 drugs were approved based on surrogate, in 4.5 years of followup, only five of them later showed survival benefits.
I guess I would say that 31 drugs on the market for five years with uncertain survival benefits, or quality of life benefits, I think that is a bit too high, out of 36. I think that we could do a better job of providing that information.
The mainstream consensus in oncology is that in some indications it’s no longer feasible to conduct trials designed to show overall survival.
This can happen, for example, because, with many lines of therapy used, it can be difficult to tease out the beneficial (or harmful) effect of any specific therapy on a patient’s overall survival.
However, in some indications—including multiple myeloma—multiple therapies were approved on non-survival endpoints.
As these drugs were used in earlier disease settings, in combinations, and sequentially, they had an impact on overall survival observable in target population.
In 2018, the American Association for Cancer Research and, separately, the American Society of Clinical Oncology invited Prasad to argue that exaggeration of benefits runs rampant in cancer care today (The Cancer Letter, June 22, 2018).
At AACR, Prasad was featured at a session titled “Is Genome-Informed Cancer Medicine Generating Patient Benefit or Just Hype?” The scene was repeated at a “meet the professor” session at ASCO.
When ASCO was planning that session, there was no shortage of candidates arguing in favor of precision medicine. However, one name clearly stood out for arguing the “con” side—Prasad.
The FDA is a failure. It rubber stamps too many useless products. It needs to either remove itself from the picture, or demand randomized trials measuring appropriate endpoints.
Vinay Prasad on Substack
“He has positioned himself as the iconoclast/John Ioannidis model for oncology. That was how he floated to the top,” Jeremy Warner, then an associate professor of medicine and biomedical informatics at Vanderbilt University and ASCO 2018 Annual Meeting Education Committee track leader of the Health Services Research, Clinical Informatics, and Quality of Care track, said to The Cancer Letter at the time. Warner is now professor of medicine and professor of biostatistics at Brown University and the associate director of data science at the Legorreta Cancer Center at Brown University.
In 2018, as chairman of a subcommittee advising the Oregon Health Authority, Prasad spearheaded an unsuccessful attempt to deny Medicaid coverage for next-generation sequencing tests in the state.
At the time, Prasad, was on the faculty of the Oregon Health & Science University and head of an advisory panel to the the Oregon Health Authority.
A review of medical literature conducted by Prasad’s group determined that “direct evidence of clinical utility is not available” for NGS technology and a randomized controlled trial would be needed to demonstrate clinical utility of NGS tests.
Such trials would be neither ethical nor feasible, opponents of Prasad’s proposal said.
Had it been enacted, this first-of-its-kind formal policy proposal by a government entity for denying coverage for the poor could potentially have been used by other state Medicaid programs as well as by private insurers dredging for reasons to deny payment for NGS tests and treatments they may point to.
Ultimately, the measure was tabled indefinitely (The Cancer Letter, Sept. 28, 2018).
After news broke of Prasad’s appointment, the biotech stock index XBI fell by about 7%.
mRNA vaccine manufacturer Moderna and cancer cell therapy developer Allogene Therapeutics were among more than a dozen companies that have lost large chunks of their market value since news of Prasad’s appointment.
