HHS Ousts Dr. Peter Marks with Biopharma Lamenting Loss of ‘Ally’ at FDA

Shares of Moderna, BioNTech, Novavax and Pfizer declined 11%, 7%, 6% and 2%, respectively, on the news, Fast Company reported. STAT News reported that Marks’ departure “is a worst-case scenario realized” for investors and “a biopharma industry that saw him as an ally.”

“Given Dr. Marks’ influence on the development of biologics and uncertainty as to who will replace him and how his legacy might continue, his departure will create a significant near-term overhang,” William Blair analyst Matt Phipps told Reuters.

The Biotechnology Innovation Organization, an industry lobbying group, said it was “deeply concerned” Marks’ resignation would “broadly impact the development of new, transformative therapies to fight diseases for the American people.”

Brian Hooker, Ph.D., chief scientific officer for Children’s Health Defense (CHD), said the reaction to Marks’ departure on the part of the markets and the pharmaceutical industry is indicative of the influence Big Pharma had over the FDA. He said:

“Marks gave an over $100 billion gift to Pfizer and Moderna via the woefully undertested and outright dangerous COVID-19 mRNA vaccine. So, yes, for the short term, I would imagine that some investors would not like his departure from the FDA.

“Marks’ departure also signals a shift from ‘sick care’ and ‘customers for life’ where, unfortunately, Pharma invests now, to ‘Make America Healthy Again’ where everyone benefits from ending chronic disease in the U.S.”

John Gilmore, executive director of the Autism Action Network, welcomed Marks’ departure. “The American people are well-served by Marks’ resignation.” Gilmore cited the “institutional failure” of the Center for Biologics Evaluation and Research (CBER) “to use the highest standards for evaluating the safety and efficacy of products that are injected in almost all American children.”

Marks has led the FDA’s CBER since 2012 and “played a key role,” The Wall Street Journal reported, in Operation Warp Speed in 2020, leading to the development of the COVID-19 vaccines.

In his resignation letter, Marks wrote: “It has become clear that truth and transparency are not desired by the Secretary, but rather he wishes subservient confirmation of his misinformation and lies.”

Resignation letter of Peter Marks from FDA’s director for the center for biological evaluation and research pic.twitter.com/KQ1unQ8EKL

— Stephanie Armour (@StephArmour1) March 29, 2025

Marks’ ‘support of immunizations conflicted with Kennedy’s skepticism’

According to the Journal, an HHS official gave Marks a choice between resigning or being fired. His resignation is effective April 5. Marks wanted to remain in his position, but “his support of immunizations conflicted with Kennedy’s skepticism.”

“Undermining confidence in well-established vaccines that have met the high standards for quality, safety, and effectiveness that have been in place for decades at FDA is irresponsible, detrimental to public health, and a clear danger to our nation’s health, safety. and security,” Marks wrote in his resignation letter.

Marks said he was “willing to work to address” Kennedy’s concerns on vaccine safety, including through a series of public meetings, but that these proposals were rejected. He also accused Kennedy of spreading “misinformation and lies” during the “ongoing multistate measles outbreak.”

But in a post on X, Steve Kirsch, founder of the Vaccine Safety Research Foundation, said that while Marks “claimed he wanted to stop misinformation,” he “refused all offers to meet with the ‘misinformation spreaders’ to settle the question on just who is spreading the misinformation.”

GAME CHANGING! Peter Marks is GONE!!!

Marks claimed he wanted to stop misinformation but REFUSED all offers to meet with the “misinformation spreaders” to settle the question on just who is spreading the misinformation! pic.twitter.com/sqYRM1eB3D

— Steve Kirsch (@stkirsch) March 29, 2025

While Marks claimed he was willing to address questions on vaccine safety, he also wrote, “Efforts currently being advanced by some on the adverse health effects of vaccination are concerning.”

One day before Marks’ resignation, Kennedy announced the creation of a new sub-agency under the Centers for Disease Control and Prevention (CDC) to focus on vaccine injuries — part of a broader restructuring of public health agencies, including the FDA.

In February, Kennedy promised that under his watch, HHS and CDC would develop a better system for tracking vaccine injuries.

Earlier this month, Reuters reported that unnamed sources within the CDC said the agency was planning to study the possible link between vaccines and autism. The story triggered negative mainstream news reports claiming the study isn’t needed.

Last week, The Washington Post, citing anonymous sources, reported that HHS had tapped researcher David Geier — a researcher and expert on the connections between toxic exposures and autism — to lead a study of possible links between vaccines and autism. The Post and other media outlets used the opportunity to attack Geier and the need for such a study.

Marks’ resignation also came as the FDA is considering a petition a group of scientists submitted earlier this year, calling upon the FDA to suspend or withdraw the mRNA COVID-19 vaccines.

Marks ‘became a cheerleader for the jab’

Writing on Substack, investigative journalist Maryanne Demasi, Ph.D., said it’s “evident there was a significant clash over vaccine safety” that led to Marks’ resignation. She said Marks’ departure “may be an opportunity for the FDA to refocus on its mission of protecting public health rather than rubber-stamping new vaccine approvals.”

Epidemiologist Nicolas Hulscher agreed. “Those who believe vaccine safety must not be questioned do not belong in our regulatory agencies. When it comes to injectable products, safety is more important than blind faith in vaccine ideology.”

According to The New York Times, while Marks “was viewed as a steady hand by many during the Covid pandemic,” he was criticized “for being overly generous to companies that sought approvals for therapies with mixed evidence of a benefit.”

The Times cited Marks’ role in pressuring two FDA scientists to approve full licensure of Pfizer’s mRNA COVID-19 vaccine in 2021, leading to the researchers’ resignation. Pfizer’s vaccine was fully licensed in August 2021 — one day later, the Biden administration mandated COVID-19 vaccination for military service members.

The rushed licensure of the Pfizer vaccine was the topic of a congressional hearing last year in which Marks testified. In a post on X Saturday, Rep. Thomas Massie (R-Ky.) wrote, “Instead of verifying safety and efficacy of the shots, Marks swept things under the rug and became a cheerleader for the jab.”

Last year I held a hearing exposing COVID vaccine malfeasance led by Peter Marks at the FDA.

Instead of verifying safety and efficacy of the shots, Marks swept things under the rug and became a cheerleader for the jab.

Yesterday Peter Marks resigned from the FDA under RFKjr.!

— Thomas Massie (@RepThomasMassie) March 29, 2025

“In order to get the vaccines to people in need when thousands of people were dying, we actually allowed the safety to be authorized with just two months of median follow-up, rather than the normal six to 12. But we were confident that that would capture adverse events,” Marks testified at last year’s hearing.

‘It was clear that he did not want to know about our injuries’

While Marks was actively engaged in the licensure of the Pfizer COVID-19 vaccine, he “remained steadfast” in dismissing concerns about injuries related to the COVID-19 vaccines as “misinformation,” Demasi wrote.

In 2023, The BMJ wrote that “more than once” during FDA meetings, Marks “expressed confusion about why it would matter to doctors whether or not regulators acknowledged that a condition might be related to the vaccine.”

Documents CHD obtained last year through a Freedom of Information Act request showed that Marks was aware of COVID-19 vaccine injuries in early 2021 when several vaccine injury victims emailed him for help. Marks blew off scheduled meetings with them.

According to TrialSite News, even though Marks was aware of the growing number of COVID-19 vaccine injuries, “vaccine injury became a political hot potato under the Biden administration,” leading Marks to abandon the vaccine-injured.

Brianne Dressen, co-founder of React19, an advocacy group for the vaccine-injured, sustained serious injuries after participating in a clinical trial for the AstraZeneca COVID-19 vaccine in 2020 and later sought meetings with Marks but was rebuffed.

“Constant emails and calls with Marks … sent while I was in constant pain, literally begging for help, begging for them to help others, begging for a lifeline. A lifeline that never ever came,” Dressen said.

Dr. Danice Hertz, a retired gastroenterologist from California injured by the Pfizer COVID-19 vaccine, also communicated with Marks but said he “brushed off anyone who contacted him regarding vaccine side effects.”

“He systematically refused to hear our pleas for acknowledgment and help,” Hertz said. “This is why the medical community is unaware of these injuries and cannot help us. One would think that the FDA would want to know about serious adverse reactions to the novel COVID vaccines. I can say from first-hand experience that they don’t … It was clear that he did not want to know about our injuries.”

Dressen said it “didn’t matter what we said or how we said it, COVID vaccine injuries were not a priority at the FDA. Didn’t matter if it was safety signals for MIS-V, dysautonomia, neuropathy, tinnitus or reports of suicides. It was never enough. We begged, we pleaded, we pushed as hard as we could, and came up with nothing.”

According to Demasi, Marks instead “blurred the line between regulation and promotion” by participating in FDA videos promoting the COVID-19 vaccines and by authorizing COVID-19 mRNA vaccines for children without sufficient testing.

“Without randomized data regarding clinical outcomes, he repeatedly approved COVID boosters for kids as young as 6 months,” Dr. Vinay Prasad, professor of epidemiology and biostatistics at the University of California, San Francisco, wrote on Substack, calling these “some of the biggest regulatory errors in the 21st century.”

Demasi said Marks “repeatedly pointed to the Vaccine Adverse Event Reporting System (VAERS) as proof of rigorous safety monitoring, yet failed to improve its efficiency.”

During last year’s congressional hearing, Marks claimed that numerous false reports of vaccine injuries are submitted to VAERS, a government-run database. However, he acknowledged, “We probably have not done a good enough job of communicating sometimes the actual numbers of deaths versus what’s in VAERS.”