Peter Marks, FDA’s top vaccine official, resigns

Peter Marks, the Food and Drug Administration’s top vaccine official, abruptly resigned from the agency on Friday, citing disagreement with Health and Human Services Secretary Robert F. Kennedy Jr.

Marks, who helped lead the successful advancement of COVID-19 vaccines during the first Trump administration, said he had tried to address Kennedy’s concerns around vaccine safety and transparency.

“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 letter to acting FDA Commissioner Sara Brenner, a copy of which was obtained by BioPharma Dive.

“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 continued.

Marks’ resignation is effective April 5. His departure will leave both of the FDA’s principal drug review offices without a permanent leader. Patrizia Cavazzoni, who was formerly head of the other office, stepped down from her role on January 18. In addition to Marks and Cavazzoni, several other agency leaders have either departed or been fired in recent months.

The Wall Street Journal first reported news of Marks’ resignation. Both HHS and FDA did not respond to multiple requests by BioPharma Dive for comment.

Marks, a physician and hematologist, has led the Center for Biologics Evaluation and Research since 2016, overseeing the agency’s review of vaccines, blood products and some genetic medicines. He helped come up with the idea for Operation Warp Speed, a cross-government initiative that helped the U.S. quickly develop, review and produce several safe and effective vaccines for COVID-19. He’s also championed the development of cell and gene therapies, pushing the agency to be more flexible and move faster — sometimes controversially so.

“I had the chance to work closely with [Marks],” Robert Califf, a former FDA commissioner under Presidents Barack Obama and Joe Biden, wrote on Bluesky. “While many people disagreed with one or another decision he made, I can assert that his interest was always with the combination of public health and the special needs of patients in this rapidly evolving world of technology.”

Marks’ ouster could spark concerns within the biopharmaceutical industry, which has been cautious in opposing Trump administration actions at HHS and the FDA.

“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,” John Crowley, head of the biotech lobbying group BIO, said in a statement.

“Marks will be sorely missed,” John Maraganore, a biotechnology leader and former CEO of Alnylam Pharmaceuticals, wrote on X.

In his letter, Marks directly cited the current measles outbreak that has sickened at least 483 people across 20 states through Thursday and led to the first U.S. death from the disease in 10 years. Kennedy, who for years pushed unproven claims about the safety of many vaccines, has been criticized for his handling of the outbreak. While he recommended parents discuss vaccination with their child’s physicians, he has also touted ineffective treatments like cod liver oil, which can cause injury if overdosed.

“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 letter.

Two doses of the measles vaccine available in the U.S. are 97% effective at preventing the disease and side effects are mild in the vast majority of cases. It has not been linked to autism, as Kennedy has long claimed.

Other actions by Kennedy since he became health secretary have also raised alarms. A meeting of advisers to the Centers for Disease Control and Prevention was postponed soon after Kennedy was sworn in, although it has since been rescheduled. According to reporting by Politico, Kennedy is also considering forcing out some of the advisers on the panel, and is scrutinizing other vaccine advisory committees.

Most significantly, Kennedy on Thursday unveiled plans to dramatically shrink HHS, including by cutting some 2,400 employees at the CDC and 3,500 at FDA. The layoffs follow a number of moves by the Trump administration to force government workers to leave or retire early, as well as to reduce funding for scientific research.

Martin Makary, President Donald Trump’s pick to run the FDA, was confirmed by the Senate Tuesday, but it’s not clear if he has been sworn in yet as commissioner.

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