Marks resigns, blames Kennedy for spreading ‘misinformation and lies’

In a scathing letter resignation letter, Peter Marks, the US Food and Drug Administration’s (FDA) top biologics regulator, said he is leaving the agency due to Health and Human Services (HHS) Secretary Robert Kennedy Jr.’s promotion of vaccine misinformation.

On Friday, Peter Marks, director of the Center for Biologics Evaluation and Research (CBER), handed his resignation letter to acting FDA Commissioner Sara Brenner. In the letter, he raised concerns that Kennedy was using his position to foster vaccine hesitancy and endangering public health.

“As you are aware, I was willing to work to address the Secretary’s concerns regarding vaccine safety and transparency by hearing from the public and implementing a variety of different public meetings and engagements with the National Academy of Sciences, Engineering, and Medicine,” said Marks. “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.”

“My hope is that during the coming years, the unprecedented assault on scientific truth that has adversely impacted public health in our nation comes to an end so that the citizens of our country can fully benefit from the breadth of advances in medical science,” he added.

Kennedy has a long history of promoting anti-vaccine views, such as the debunked notion that vaccines cause autism.

During his confirmation hearing, Kennedy promised not to allow his personal opinions on vaccines to interfere with HHS’s vaccine initiatives. Since taking the reins, the department has cancelled multiple vaccine advisory committee meetings and has halted ad campaigns aimed at promoting the seasonal flu vaccine.

In recent months, Kennedy also initially downplayed a measles outbreak in Texas. Eventually, after the outbreak worsened, he penned an editorial saying the measles vaccine protects children, while emphasizing that it’s up to the parent’s discretion to inoculate their kids. He has also promoted vitamin A as a treatment for the disease; however, recent reports indicate that some children with measles in Texas have been treated for vitamin A toxicity.

In his resignation letter, Marks cited the handling of the measles outbreak as another instance of vaccine misinformation harming the public.

“The ongoing multistate measles outbreak that is particularly severe in Texas reminds us of what happens when confidence in well-established science underlying public health and well-being is undermined,” said Marks. “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.”

Several stakeholders and experts have voiced concerns about Mark’s resignation's implications for FDA and public health in general.

Howard Sklamberg, a partner at Arnold & Porter and a former FDA deputy commissioner for global regulatory operations and policy, noted that Marks is not only a top biologics expert, especially for vaccines and cell and gene therapies, but has led the agency in evaluating the COVID-19 vaccine and other groundbreaking therapies.

"Dr. Marks’s departure robs the public of someone with great expertise and integrity and an ability to get things done," said Sklamberg. "You can’t easily replace him because even someone with technical knowledge won’t have his skill at operationalizing."

"It’s not my place to tell the administration what to do," he added. "I hope that they will find a replacement that will build trust with the broader public, the scientific community, doctors, and patients who rely on FDA."

“What he describes in his resignation letter should be frightening to anyone committed to the importance of evidence to guide policies and patient decisions,” said former FDA Commissioner Robert Califf in a LinkedIn post. “I hope this will intensify the communication across academia, industry and government to bolster the importance of science and evidence. In other words--this is not an issue that will go away if you just keep your head down and do your work.”

Califf also spoke to Focus about the impact Marks' departure will have on FDA, noting that he was critical to the agency's work in reviewing and getting vaccines, cell and gene therapy, blood, and other biologics to market.

"The loss of Dr. Marks and others will impair the speed and quality of the work, at least for some time," he said. "Experience and ability to interact effectively with the regulated industries cannot be replaced easily."

Califf also warned that the kind of direct political interference that Marks faced risks public confidence in FDA's work. Furthermore, he said Kennedy and the administration are making a big mistake if they don't value the experience of FDA employees.

"If the anti-vaccine rhetoric from HHS leads to anti-vax efforts in CBER, we will almost certainly experience continued deterioration of our vaccine rates with corresponding death and serious illness," he added.

Similarly, another former top FDA official who asked not to be named for fear of professional reprisal told Focus that the recent staff cuts to the agency and Mark’s resignation will have a serious detrimental effect on public health.

“I think this plus the proposed cuts will be catastrophic for FDA,” said the official. “As far as public health, it is the combined efforts of this administration to undermine it that put the country at risk in a pandemic or other outbreak.”

During Kennedy’s confirmation hearing, Sen. Bill Cassidy (R-LA), chair of the Senate Health, Education, Labor and Pensions (HELP) Committee, was one of the only Republicans to raise concerns about Kennedy’s views on vaccines. He said that if Kennedy imposed his personal views about vaccines on HHS, he would hold him accountable.

However, after the news that Marks had resigned because of Kennedy, Cassidy went to X, formerly Twitter, to urge Kennedy to replace Marks with someone of similar caliber.

“I thank Dr. Marks for his dedicated service to the health of our country. His departure is a loss to the FDA,” said Cassidy. “Commissioner Makary and Secretary Kennedy should replace him with someone of similar stature and credibility amongst the scientific community, who will lead without bias.”

Sen. Patty Murray (D-WA), who also serves on the HELP Committee, however, had a more dire message about the consequences of Marks' resignation.

“No one should ignore the chilling warning coming from FDA’s former top vaccine official, who had a front-row seat to how Trump and RFK Jr. are pushing disinformation and lies that openly risk Americans’ health and safety," Murray told Focus. "We’re watching in real-time as this administration pushes out qualified public health officials en masse while elevating quack conspiracy theorists who want to relitigate long-settled science instead of find new treatments and cures."

"I'll keep saying it: the consequences of this administration’s all-out assault on Americans' health will be deadly,” she added.

John Crowley, CEO of the Biotechnology Innovation Organization (BIO), issued a statement praising Marks for his work and voiced concern about how his departure will affect innovation and regulations.

“The U.S. has long been recognized as the world leader in medical and scientific innovation and regulation, grounded in transparency and scientific rigor," he said. "We are deeply concerned that the loss of experienced leadership at the FDA will erode scientific standards and broadly impact the development of new, transformative therapies to fight diseases for the American people."

“It is imperative that we retain and recruit scientific expertise and strong leadership at our health agencies and that the high standards that are the hallmark of these health institutions are upheld and advanced," he added.

Steven Grossman, an FDA regulatory consultant and author of FDA Matters, penned a blog post praising Marks' leadership and willingness to pursue new ideas for the betterment of public health.

"FDA is immeasurably worse for Peter’s departure, as are the American people," said Grossman. "I worry—and you should too—that this is a harbinger of FDA’s fate: to be judged by individuals who do not believe in its fundamental purpose."

"I do not think the details of Peter’s resignation matter," he added. "We can be fairly sure that he was asked to agree to some action—a statement, advice to the American people, or some study protocol—and felt his attempts to find common ground were not reciprocated. He refers to a commitment to truth and transparency and it is clear that he and the Secretary see these differently."

Marks resigns, blames Kennedy for spreading ‘misinformation and lies’

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