A Washington Post report on March 28 that the US Department of Health and Human Services (HHS) forced the Food and Drug Administration's (FDA's) top vaccine official—Peter Marks, MD—to resign or be fired quickly caught the attention of some lawmakers, along with members of the scientific and business communities.
Marks submitted his resignation letter, with an effective date of April 5. The development comes amid a major change in focus under the leadership of new HHS Secretary Robert F. Kennedy Jr., a long-time vaccine skeptic, which the agency spelled out in a March 27 announcement.
Marks: Kennedy wants support for misinformation, lies
Marks is a hematologist oncologist who has led the FDA Center for Biologics Evaluation and Research (CBER) since 2016 after serving as its deputy director since 2012. He has widely been credited as playing a key role in Operation Warp Speed, a partnership between the federal government and the private sector that streamlined the development, production, and distribution of COVID-19 vaccine.
In his resignation letter, published by the Post and other media outlets, Marks raised concerns about efforts to undermine confidence in vaccines, especially against the backdrop of a multistate measles outbreak that is especially severe in Texas. Marks said he was willing to work with Kennedy to address his concerns over vaccine safety and transparency. Kennedy has minimized the outbreak and has suggested alternative treatments, including vitamin A, which some hospital officials said has been linked to cases of liver problems.
"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," Marks wrote.
In a statement to CBS News, HHS said if Marks doesn't want to get behind restoring science to its golden standard and promoting radical transparency, he has no place at the FDA under Kennedy's leadership.
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.
HHS's recent appointment of a vaccine critic to lead a new study on the purported link between vaccines and autism has raised questions about the agency's scientific standard under Kennedy. Numerous studies have shown no link between childhood vaccines and autism.
Although Kennedy has pledged radical transparency, HHS recently sidelined its vaccine advisory committee, an independent group of scientists, which has regularly live-streamed its meetings and posted all documents for the public to review in advance. Instead, HHS convened its own panel of federal experts that made recommendations for the strains to include in the 2025-26 flu vaccines in a nonpublic meeting and posted the presentations afterwards. The HHS committee also excluded presentations from vaccine manufacturers.
Lawmakers want credibility, worry about vaccine availability
The day after news broke of Marks' departure, some lawmakers on both sides of the aisle weighed concerns about the new development.
Sen Bill Cassidy, MD (R-LA), cast the tiebreaking vote that advanced Kennedy's HHS nomination to a full Senate vote in early February, after getting specific promises from Kennedy. On X, Cassidy thanked Marks for his service and said his departure was a loss to the FDA.
"Commissioner Makary and Secretary Kennedy should replace him with someone of similar stature and credibility amongst the scientific community, who will lead without bias," Cassidy wrote.
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On the same day, Rep Gerald Connolly, (D-VA), ranking member of the House Committee on Oversight and Government Reform, announced that he sent a letter to Kennedy demanding the immediate resumption of the agency's core function to make recommended vaccine available, following what he said was the shocking resignation of the FDA's top vaccine official.
Connolly also raised concerns about HHS canceling vaccine advisory committee planning and grants for life-saving vaccine research. He said the administration’s attacks on vaccine availability and research come alongside broader attacks on science and a worsening measles outbreak that has already killed one person and is suspected in the death of another.
He also called out Kennedy's persistent push of widely debunked vaccine claims and spread of misinformation, including an assertion that children of certain races and ethnicities don't need to be vaccinated against a range of diseases.
Concerns from scientists, industry
Ashish Jha, MD, MPH, dean of the Brown University School of Public Health, said on X that Operation Warp Speed was one of the best examples that "America can still do hard things…. Its chief scientific architect was Peter Marks." Jha served as White House Coronavirus Response Coordinator in the Biden Administration.
In a separate post, he said Marks' ouster dramatically weakens the FDA and makes it less effective.
Today Public Citizen, a nonprofit consumer advocacy organization based in Washington, DC, said about 1,900 members of the National Academies of Sciences, Engineering, and Medicine, speaking individually, have released a letter to the American public to sound a clear warning that the nation's scientific enterprise is being decimated.
In a statement, Public Citizen said the warning comes at a critical time with Marks' ouster and Kennedy continuing to consolidate his control over HHS and advance an agenda "full of misinformation and lies."
Meanwhile, the leader of the Biotechnology Innovation Organization (BIO), an advocacy group that represents the biotechnology industry, on March 29 issued a statement on Marks' resignation.
John Crowley, JD, BIO president and chief executive officer, said that, under Marks' leadership, the FDA has shepherded in a new era of breakthroughs, from new vaccines to cell and gene therapy cures that have saved lives.
"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."
We are deeply concerned that the loss of experienced leadership at the FDA will erode scientific standards...
Crowley added that it's important to uphold and advance the high standards that health institutions are known for, and that BIO is committed to working with the new FDA commissioner and presidential administration to support a strengthened and modernized FDA.
