Peter Marks, the venerable head of the FDA’s Center for Biologics Evaluation and Research, has been forced out. In this special edition of BioPharm Executive, BioSpace takes a deep dive into the instability of the HHS.
This deep dive was originally published Apr. 2, 2025 as a special edition of Biopharm Executive. Subscribe to Biopharm Executive to receive market insights, deals, business stories and deep dives into key policy issues impacting biopharma.
Peter Marks, the venerable head of the FDA’s Center for Biologics Evaluation and Research, has been forced out.
Given the choice between resigning or being fired, Marks chose to step aside, writing in his resignation letter that he could no longer work with Health and Human Services Secretary Robert F. Kennedy Jr.
“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.
A scientist and physician by training, Marks joined the FDA in 2012, working his way up to head of the CBER division in 2016. He was responsible for overseeing the safety and effectiveness of complex biological products, from vaccines to gene therapies to blood products.
Marks was a champion of innovative therapies, particularly cell and gene therapy, and was committed to finding a regulatory solution to pay for them. He was also known for his embrace of surrogate endpoints and the accelerated approval pathway, and a rare disease advocate. But the issue that may have drawn Kennedy’s ire was his work with the Trump administration’s Operation Warp Speed to develop COVID-19 vaccines to combat the pandemic.
Accordingly, the resignation sent biotech shares tumbling.
The biopharma industry has already been reeling from several years of turmoil post-pandemic, during which a sugar rush infused the industry with an unsustainable flow of cash and new companies. Experts had begun to see 2025 as the year things would finally turn around. Instead, Marks’ exit pushed the S&P Biotech Index down even further.
Stifel said the Marks departure was “arguably biotech investors’ greatest fear” with the Trump administration coming true.
As the industry reacted to Marks’ resignation, another wave of layoffs began at HHS, including the FDA, with many employees reportedly served notice that they were relieved of their duties as they arrived at work on Tuesday.
The cuts are part of Kennedy’s broader goal to remove as many as 10,000 staffers from HHS. Peter Stein, director of the Center for Drug Evaluation and Research’s Office of New Drugs, was among the casualties at the FDA.
Heard Around Biopharma
The FDA as we’ve known it is finished, with most of the leaders with institutional knowledge and a deep understanding of product development and safety no longer employed. I believe that history will see this a huge mistake.
We have been told over and over ‘don’t worry, RFK will not interfere with vaccines or reviewers at FDA.’ Now he’s crossed the red line on both.
[Marks’] resignation is far more than the departure of a highly respected figure. It is a stark and unequivocal warning. His words are as courageous as they are devastating: truth and transparency are no longer welcome. What is demanded instead is obedience. This letter should shake us all.
If there is reason to be hopeful for the near term, it’s that Dr. Marks was not a lone actor at FDA; we think the agency broadly, across divisions, and many existing personnel, more or less reflected his philosophy.
Poll: Do you believe Kennedy should get the axe?
Following the announcement of 10,000 job cuts across the Department of Health and Human Services and forced resignation of widely respected FDA CBER chief Peter Marks, analysts at Cantor Fitzgerald called for HHS Secretary Robert F. Kennedy Jr.’s dismissal—less than two months after his confirmation.
