Media Lying About Peter Marks Departure From FDA

Biotech and Pharma stocks are being hammered today as the financial import of Dr. Marks departure from FDA sinks in:

https://www.reuters.com/business/healthcare-pharmaceuticals/biotech-stocks-tumble-reports-fdas-top-vaccine-regulator-leave-2025-03-31/

Drugmakers sink after key FDA official ousted as Trump plans health overhaul
By Manas Mishra - March 31, 2025

Summary
*  Biotech shares pressured after resignation
*  S&P 500 biotech ETF down 4.9%, Moderna slumps 12.3%
*  Marks' departure adds uncertainty

March 31 (Reuters) - Shares of U.S. drugmakers fell on Monday after reports that the Food and Drug Administration's top vaccine official, Peter Marks, had been forced to resign, the most high-profile exit at the regulator as the Trump administration undertakes an overhaul of federal health agencies.

The pharma and biotech sector has been under pressure since Donald Trump returned to the White House earlier this year.

Shares have dropped on worries Trump's extensive plans for tariffs will include drugs, which have traditionally been excluded from such levies, and Secretary of Health and Human Services Robert F. Kennedy Jr's plans to revamp the federal agencies.

Kennedy, an environmental lawyer, has a history of sowing doubts about the safety and efficacy of vaccines.

Marks, who played a key role in Trump's first term in developing COVID-19 vaccines, will leave effective April 5, according to his resignation letter, which was first reported by the Wall Street Journal on Friday. Marks criticized Kennedy's views on vaccines in the letter.

The S&P 500 biotech ETF slid 4.9%, which would add to the roughly 6% drop this year, as the resignation amplified uncertainty among biotech investors.

"It's no secret that biotech has been under immense pressure recently given broader macro issues, this unfortunate update does nothing to reassure investors or provide relief," said BMO Capital Markets analyst Evan Seigerman.

Vaccine-focused companies such as Novavax (NVAX.O), opens new tab and BioNTech fell about 7%, while gene therapy developers including Taysha Gene Therapies (TSHA.O), opens new tab, Solid Biosciences (SLDB.O), opens new tab and Sarepta Therapeutics (SRPT.O), opens new tab slumped between 15% and 23%.

Kennedy has announced plans to reshape the federal public health agencies that could involve firing thousands of workers.
The reports on Friday said Marks was given the choice by a Health and Human Services (HHS) official to resign or be fired. As director of the FDA's Center for Biologics Evaluation and Research, Marks has publicly supported programs that expedited the development of rare disease treatments and gene therapies during his tenure.

"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," said William Blair analyst Matt Phipps.

Marks' departure follows the exit of head of the FDA's drug evaluation unit, Patrizia Cavazzoni, roughly two months ago.
While a replacement is still unclear, "there is clearly a risk that the candidate's views will be in line with Secretary Kennedy's on vaccines," Phipps said.

Marks did not respond to a request for comment over email on Monday.

https://www.politico.com/news/2025/03/31/new-fda-commissioner-signed-off-on-ousting-top-vaccine-regulator-after-private-swearing-in-00260582

New FDA commissioner agreed to oust top vaccine regulator after private swearing-in
The forced resignation of Peter Marks has unsettled scientists and researchers.
By Adam Cancryn and David Lim - March 31, 2025

Food and Drug Administration Commissioner Marty Makary signed off on the ouster of top vaccine official Peter Marks shortly after being quietly sworn in as the agency’s new leader late last week, four people familiar with the matter told POLITICO.

The forced removal was Makary’s first major act as commissioner and sent a powerful signal to a stunned Washington that was already anxious about the role vaccine skepticism would play under Secretary Robert F. Kennedy Jr.’s Health and Human Services Department. Makary and Kennedy had previously agreed to push out Marks, who led the FDA’s vaccine division for more than eight years, as part of a broader overhaul of HHS leadership.

The decision has alarmed lawmakers and the pharmaceutical industry, who see it as an effort by Kennedy to lay the groundwork for remaking the government’s approach to vaccines after years of sowing doubts about the shots.

While Kennedy made the final call to force Marks’ exit, he did so only after Makary consented, said the people familiar, who were granted anonymity to discuss private deliberations. Makary was sworn in late last week, according to multiple people granted anonymity to discuss the timing.

Makary’s involvement in the decision was not widely known even within the FDA, which has yet to acknowledge that he’s already been sworn in as head of the agency. On the agency’s website, Sara Brenner is still listed as the acting commissioner of food and drugs.

Even Marks appeared unaware of Makary’s status on Friday, addressing his resignation letter to Brenner and using his parting words to take aim at Kennedy. Marks declined to comment.

“I was willing to work to address the Secretary’s concerns regarding vaccine safety and transparency,” Marks wrote. “However, 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.”

Makary’s support for driving out Marks is likely to further unsettle drug companies and supporters of the FDA, who had hoped that the former Johns Hopkins surgeon and researcher would serve as a bulwark against major changes to the nation’s vaccine policies.

Makary gained prominence in recent years as a vocal critic of the FDA and of the government’s response to the Covid pandemic. But unlike Kennedy, he has generally supported vaccines and never embraced the debunked theory advanced by the HHS secretary that they are linked to autism.

The Senate confirmed Makary to run the FDA last Tuesday. But he was not expected to begin working out of his office at the agency until this week, the people said.

An HHS spokesperson declined to comment. The Pink Sheet first reported the timing of Makary’s swearing in.

Makary has discussed seeking additional changes across the FDA in his first weeks, including installing new leadership at another major center within the agency, the Center for Tobacco Products, three of the people said.

That potential change would come on top of the upheaval already underway at the FDA. Since Trump’s election, the agency’s top drug and food officials have quit, as well as its principal deputy commissioner. A sweeping reorganization that Kennedy announced last week would reduce the agency’s staff by 3,500 over the next several weeks.

But amid the restructuring, Marks’ ouster has generated outsize concern within the FDA and across the health care landscape. Vaccine manufacturers Moderna and Novavax saw their stocks drop sharply when the market opened Monday.

Biotechnology Innovation Organization President and CEO John Crowley said the loss of leadership at the FDA could erode scientific standards and impact the development of new medicines.

“We advocated strongly for Peter’s continued leadership,” Crowley texted.

While at times a polarizing figure at the agency, Marks is credited with helping establish the Operation Warp Speed initiative during President Donald Trump’s first term that delivered a Covid vaccine in a matter of months.

The vaccine regulator had won the trust of FDA commissioners and lawmakers in both parties, developing a reputation over more than 12 years at the FDA’s Center for Biologics Evaluation and Research as a fierce defender of scientific independence and the agency’s rigorous approach to developing and testing vaccines.

“Peter’s commitment to bringing the best science and data to the development and availability of lifesaving biomedical technologies, from gene and cell therapies to the Trump Administration’s Operation Warp Speed, has saved countless lives,” Mark McClellan, who ran the FDA during the George W. Bush administration, told POLITICO. “His decade-long leadership at the FDA is a big reason why the FDA is the gold standard for advancing the most innovative breakthrough medicines.”

Robert Califf, commissioner during the Biden administration, said last week that Marks’ “interest was always with the combination of public health and the special needs of patients.”

“The role of the FDA Commissioner is largely to fend off political interference so that career civil servants without financial conflicts can make decisions based upon the statutes and rules governing these decisions,” Califf wrote in a LinkedIn post on Monday.

Sen. Bill Cassidy (R-La.), a physician who cast a crucial vote in favor of Kennedy’s confirmation, said in a statement Saturday that Makary and Kennedy should “replace him with someone of similar stature and credibility amongst the scientific community,” adding that Marks’ departure was “a loss to the FDA.”

But Kennedy and his allies — which include prominent anti-vaccine figures — had long expressed skepticism of Marks and the FDA’s approach to vaccines, often accusing the agency without evidence of downplaying the health risks they believe the shots pose.

The HHS secretary said during a NewsNation interview last week that he wants to create an office within the Centers for Disease Control and Prevention that would specialize in “vaccine injuries.” Kennedy also ordered a large-scale study on potential links between vaccines and autism, despite extensive research that has failed to find evidence of such a connection.

Kennedy’s approach to the measles outbreak put him at odds with Marks as well, the vaccine regulator wrote in his resignation letter. Kennedy has offered only tepid support for the measles vaccine while also promoting the questionable use of vitamin A supplements as a treatment for the disease.

“Undermining confidence in well-established vaccines that have met 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 a statement shortly after Marks’ resignation, an HHS official blamed Marks for failing to support Kennedy’s goals and said “he has no place at FDA under the strong leadership of Secretary Kennedy.”

Makary has yet publicly addressed Marks’ departure.

Dr. George F. Tidmarsh, an Adjunct Professor in Pediatrics and Neonatology at the Stanford University School of Medicine, goes into further detail on the reasons that Dr. Peter Marks was dismissed from the FDA:

https://realclearwire.com/articles/2025/04/01/follow_the_science_why_peter_marks_was_asked_to_leave_the_fda_1101329.html

Follow the Science: Why Peter Marks Was Asked to Leave the FDA
By George F. Tidmarsh - April 01, 2025

On Friday, Dr. Peter Marks announced his resignation from the U.S. Food and Drug Administration (FDA) as Director of CEBR (Center for Biologics Evaluation and Research) citing differences with Health and Human Services (HHS) Secretary Kennedy regarding vaccines. The New York Times, Washington Post, and other media outlets such as STAT News breathlessly reported that “FDA’s top vaccine scientist had been pushed out.” We have been told that science is at risk. The irony of these reports is that Marks didn’t resign and is not a vaccine scientist. Dr. Marks was asked to leave and then subsequently wrote that he did not want to become “subservient to [Secretary Kennedy’s] misinformation and lies.”

Peter Marks is not a hero of the resistance but instead has been subverting the scientific process at FDA for years.

The media proclamation that Dr. Marks’ is “FDA’s top vaccine scientist” is ironic because he decided to give himself that position. Marks is a physician but has no clinical or scientific training in vaccines or immunology. Dr. Marks trained as an oncologist, a field far from the important and complex area of vaccine biology. At FDA in 2021, Dr. Marks removed top career vaccine scientists so he could force through the approval of the COVID vaccine to meet an arbitrary Biden administration deadline. He also declined to convene the FDA Vaccine Advisory Committee to review his decision. These events are clearly outlined in the June 2023 House Judiciary Hearings. Marks ousted Dr. Gruber and Dr. Krause, the top scientists at the Office of Vaccine Research, due to “intransigence” of these real vaccine experts to not ram through the approval of the vaccine. Drs. Gruber and Krause had voiced concerns that they needed more time to understand the safety of the vaccine especially as it relates to inflammation of the heart, now a well known and accepted toxicity of the COVID vaccine. Marks approved the use of the vaccine in children despite the known fact that children have an extremely low risk of serious health effects of COVID-19 infection and yet a known significant increased risk of serious vaccine related toxicity.

On at least three additional, documented occasions during the Biden administration as Director of CBER, Marks disregarded the opinions and expert advice of long-time career scientists to advance his own dangerous agenda. In addition to ignoring and overruling FDA’s top vaccine scientists during the pandemic, Marks also overruled FDA career scientists and supported the approval of the Alzheimer’s drug ADUHELM; a decision later overturned. In 2023, he overruled his own staff scientists amid their concerns and those raised by an FDA Advisory Board to grant approval of ELEVIDYS, a gene treatment for Duchenne muscular dystrophy (DMD). Furthermore, in 2024 Marks expanded the approval of ELEVIDYS despite FDA staff objections and without FDA Advisory Committee input.

As tragic evidence of Marks’ failed judgement, just 2 weeks ago, the company that markets the therapy ELEVIDYS announced that a treated patient died of fulminant liver failure. Marks overruled his own career staff and experts to drive through a risky and unproven therapy that has now killed a patient. This tragedy should not have happened. After the initial FDA approval, the company conducted a subsequent trial which failed to meet the primary efficacy endpoint. On top of that, ELEVIDYS has proven toxicity including liver failure (22% of patients) and increase in serious adverse events. Despite the lack of proven efficacy and the concerning toxicity profile, Dr. Marks rammed through the initial ELEVIDYS approval and the full approval in June of 2024 against the counsel of his staff and the expert panel. While advocates point to the need for new therapies in severe debilitating diseases such as DMD, giving patients and families hope on a toxic therapy that does not provide a clinical benefit rises beyond simple incompetence. A patient died needlessly, and others have been harmed due to this incompetence.

Dr. Marks also failed to protect public health when he overruled career FDA scientists and supported the approval of the Alzheimer’s treatment AUDHELM, a controversial approval that was subsequently overturned. ADUHELM was approved in June 2021 despite strident objections from FDA staff and against the recommendations of an Advisory Board. In fact, two prominent members of that advisory board resigned in protest of the decision. These members cited a lack of clear efficacy and the risk of serious toxicity including brain swelling and bleeding that can be life threatening. These events led to a congressional investigation which found that FDA had “unusually close” interactions with Biogen, the AUDHELM sponsor and applicant. In January 2024, Biogen decided to remove ADUHELM from the market after confirmatory trials failed to show patient benefit. So, Dr. Marks again supported a dangerous and ineffective therapy that cruelly gave patients hope and provided nothing but risk and cost to Americans.

Both the ADUHELM initial approval and the ELEVIDYS approvals demonstrate that ignoring basic tenants of the use and interpretation of clinical trial data can be very damaging to public health. By ignoring these well-tested tenants of FDA review and approval, Marks endangered patients, gave false hope to those in desperate need and cost vast amounts of money that our health case system can ill afford. It cannot be overstated how destructive this practice is to drug development. This uneven application of basic clinical trial data interpretation calls into question the impartiality and credibility of the FDA. This is particularly relevant now as a patient who otherwise could have lived many more years died from an expected toxicity. And we have yet to fully determine the harm caused by Dr. Marks decision to remove the most experienced and trusted vaccine scientists that simply wanted more time to understand the, now proven, risks of the COVID vaccine.

While Dr. Peter Marks may try to claim differences with Secretary Kennedy on vaccines and the legacy media try to paint Marks as the FDA hero, the real reason he was terminated is that he made bad decisions that were contrary to FDA long-standing policies and which ran counter to the evaluations of professional career staff at FDA. Thanks to Dr. Marks’ terrible decisions, we are left with a drug that has no proven benefit and that just killed a young patient, a vaccine that is not completely safe is being administered to children that have no significant risk of harm from the underlying infection, and an overburdened healthcare system that had to pay billions for another unproven, harmful therapy. Advocates for Dr. Marks claim that he has acted to help patients with life-threatening conditions which have no alternative treatments. But in reality, he catered to industry and hurt patients. Of course, we should strive to advance safe and effective therapies for such conditions, but we should not approve ineffective and dangerous therapies simply to put something out on the market. Unfortunately, Dr. Marks has repeatedly disregarded long-held FDA policy that is in place to protect patients. That is malpractice not heroism.

Dr. Peter Marks says he refused to grant Health and Human Services Secretary Robert F. Kennedy Jr. access to the VAERS FDA vaccine safety database.  Once upon a time, this would be grounds for a felony conviction and a long vacation in a BoP Club Fed facility.  At the very least, he should lose his pension and medical license:

https://apnews.com/article/kennedy-rfk-vaccines-measles-fda-injury-marks-5eda3335bae9b8df88795c2d5e09ae69

Ex-official says he was forced out of FDA after trying to protect vaccine safety data from RFK Jr.
By Matthew Perrone - April 7, 2025

WASHINGTON (AP) — Shortly before he was forced to resign, the nation’s top vaccine regulator says he refused to grant Health Secretary Robert F. Kennedy Jr.'s team unrestricted access to a tightly held vaccine safety database, fearing that the information might be manipulated or even deleted.

In an interview with The Associated Press, former Food and Drug Administration vaccine chief Dr. Peter Marks discussed his efforts to “make nice” with Kennedy and address his longstanding concerns about vaccine safety, including by developing a “vaccine transparency action plan.”

Marks agreed to give Kennedy’s associates the ability to read thousands of reports of potential vaccine-related issues sent to the government’s Vaccine Adverse Event Reporting System, or VAERS. But he would not allow them to directly edit the data.

“Why wouldn’t we? Because frankly we don’t trust (them),” he said, using a profanity. “They’d write over it or erase the whole database.”

Marks spoke to the AP on Sunday, after officials in Texas confirmed the nation’s second measles-related death in an unvaccinated child this year. Marks attributed the death to the tepid response from the U.S. Department of Health and Human Services, which again encouraged the measles, mumps and rubella vaccine on Sunday but has also promoted claims about vitamin A supplements.

During his Senate confirmation hearings, Kennedy told lawmakers he is not “antivaccine.” But since taking office, he’s promised to “investigate” children’s shots, and agencies under his watch have terminated vaccine-related research, canceled meetings of vaccine advisers and are poised to reinvestigate ties between vaccines and autism — a link debunked long ago.

Since being sworn in, “Mr. Kennedy has increased the pace by which he intends to minimize the use of vaccines in this country,” Marks said.

An HHS spokesperson said Kennedy has advocated for vaccination multiple times since becoming health secretary and pointed to a social media post Sunday in which he called the vaccine “the most effective way to prevent the spread of measles.” But hours later, Kennedy also praised “extraordinary healers” in the Mennonite community who he said were using a drug combination to treat measles. Neither of the drugs has been shown to directly treat the disease, which is a viral infection.

Marks is highly regarded by former FDA leaders and biotech industry executives, but his time at the agency was not without controversy. During the COVID-19 pandemic he was alternately criticized for being too slow — under Trump— and too fast — under Biden— to authorize new vaccines and boosters.

Marks says he “tried everything” to work with Kennedy. At the center of that effort was a plan to increase publicly available information about vaccine ingredients, safety and side effects.

Marks and his team had hoped to kick off the initiative with a two-day public “listening session,” followed by an expert report written by an independent organization, such as the National Academies of Sciences.

Overhauling the VAERS system

The centerpiece of the effort would be a vast overhaul of the VAERS system, maintained by the FDA and Centers for Disease Control and Prevention.

FDA and CDC scientists monitor the database for “possible signals” of emerging problems with vaccines. But analyzing the data requires both medical and statistical expertise, because anyone can submit unverified reports of side effects, injuries and death. The public-facing website warns that the data is unverified and may be incomplete or inaccurate. Misinterpretations of VAERS have long been central to anti-vaccine groups and messaging.

Marks notes that government scientists spend hours adjudicating each report of serious injury or death, often by tracking down death certificates and interviewing health providers. It’s not unusual for investigators to find reports of deaths that were caused by something totally unrelated to a vaccine, like a car crash, or that a death occurred months after vaccination in someone with a serious illness.

Much of that detail is redacted for legal reasons. But Marks said his office was committed to making much more information available.

“This is a legitimate thing that I actually was willing to compromise on,” Marks said “We need to make VAERS more transparent so that people can understand that we actually do the work on the backend.”

Details of Marks’ plan were confirmed by a second person with direct knowledge of the matter, who spoke on condition of anonymity because they did not have permission to speak publicly about internal agency matters.

The proposal was sent to FDA’s acting commissioner, Trump appointee Dr. Sara Brenner, in mid-February, but Marks and his team did not hear back.

By mid-March, Marks’ office was fielding multiple requests from Trump administration staffers seeking full access to the VAERS database. In responding to the requests, Marks and his staff emphasized the sensitive nature of the data, which includes confidential personal, medical and corporate information.

The HHS spokesperson said that it would make “perfect sense” for staffers working for Kennedy to seek access to the VAERS database to do their own analysis.

Marks says Kennedy is ‘walled off’ from FDA

Marks said he never spoke directly with Kennedy, whom he described as “walled off” from FDA officials.

On the day he was forced out of his post, Marks said he was summoned to a meeting at HHS headquarters.

Two senior HHS officials greeted him and recalled Marks’ work during the COVID-19 pandemic; he had coined the name and developed the concept for “Operation Warp Speed,” which rapidly accelerated the development of vaccines and therapies to treat the virus.

After an awkward silence, Marks said, one of the officials told him: “Look, he wants you gone.” According to Marks, it was an obvious reference to Kennedy.

“It was pretty clear that either I was going to resign, or they were going to fire me,” Marks said.

He submitted his resignation later that day, citing Kennedy’s support for “misinformation and lies” about vaccines.

The HHS spokesperson said Kennedy is “installing scientists committed to reversing the chronic disease crisis,” and that Marks was a “rubber stamp” for the drug industry.

This week, Kennedy is making stops across the southwestern U.S. as part of a “Make America Healthy Again” tour focused on fluoridation, food dyes and other issues.

Marks said Kennedy should be working to get more children vaccinated to stop the outbreak.

“I consider these needless and senseless deaths,” Marks said. “These kids should get vaccinated. That’s how you prevent people from dying of measles.”