FDA CBER Director Peter Marks Resigns

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In a letter to Sara Brenner, FDA’s acting commissioner of Food and Drugs, Peter Marks, the director of FDA’s Center for Biologics Evaluation and Research (CBER), resigned his post. Marks pointed to an “unprecedented assault on scientific truth” that “adversely impacted public health” and the current administration’s concerns over vaccine safety (1) in his resignation.

“Over the past 13 years I have done my best to ensure that we efficiently and effectively applied the best available science to benefit public health,” Marks said in the letter. “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. 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.”

In a statement released by the Biotechnology Innovation Organization (BIO), John Crowley, BIO director and CEO, praised Marks for shepherding a “new era of scientific breakthroughs” such as vaccines and cell and gene therapies, and he voiced his concern 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. We are committed to working with the new Commissioner and the Administration to support and enable a strengthened and modernized FDA,” Crowley said (2).

According to NPR, an official at the Department of Health and Human Services (HHS) stated (3), “if Marks ‘does not want to get behind restoring science to its golden standard and promoting radical transparency, then he has no place at FDA under the strong leadership of Secretary Kennedy.’"

NPR also cited a comment by Dr. Paul Offit of the University of Pennsylvania, who referred to HHS Secretary Robert F. Kennedy, Jr. as a “wolf guarding the hen house” (3).

CBER regulates biologic products for use in humans, including vaccines. Marks joined FDA as deputy center director of CBER in 2012 and became the center’s director in 2016. He was a part of Operation Warp Speed, which was instrumental in the development of COVID-19 vaccines. He has also put forth several initiatives to advance cell and gene therapies (4). His resignation is effective April 5, 2025.

“I leave behind a staff of professionals who are undoubtedly the most devoted to protecting and promoting the public health of any group of people that I have encountered during my four decades working in the public and private sectors,” Marks said of his staff in the letter. “I have always done my best to advocate for their well-being and I would ask that you do the same during this very difficult time during which their critical importance to the safety and security of our nation may be underappreciated.”

Reuters reported that pharmaceutical company stocks fell on Monday after Marks’ resignation. Shares in vaccine companies such as Moderna fell between 6% and 12% (5).

On March 27, HHS announced a restructure of the organization in response to a Trump Administration Executive Order, which will include the reduction of its workforce by 10,000 full-time employees. Cuts to FDA’s staff include the reduction of approximately 3500 full-time employees. HHS stated the reduction will not impact drug, device, or food reviewers or inspectors and will streamline operations and centralize administration functions (6, 7).

References

1. Marks, P. Letter to Sara Brenner, MD, MPH Acting Commissioner of Food and Drugs U.S. Food and Drug Administration. March 28, 2025. Posted by The New York Times. https://static01.nyt.com/newsgraphics/documenttools/c946b864e1dc08f9/05e7e4f0-full.pdf
2. BIO. BIO Statement on Resignation of Peter Marks from the FDA. March 29, 2025. BIO.org. https://www.bio.org/press-release/bio-statement-resignation-peter-marks-fda
3. Stein, R. The Top FDA Vaccine Official is Forced Out, Cites RFK Jr.'s 'Misinformation and Lies'. NPR.org. March 28, 2025.
4. Marks, P. Updates on the FDA’s Efforts to Accelerate Advances in Cell and Gene Therapy. ARM Cell & Gene State of the Industry Briefing. Jan. 13, 2025. https://alliancerm.org/wp-content/uploads/2025/01/ARM-Marks-011325.pdf
5. Mishra, M. Pharma Stocks Sink after Ouster of Top FDA Vaccine Regulator. Reurters.com. March 31, 2025. https://www.reuters.com/business/healthcare-pharmaceuticals/biotech-stocks-tumble-reports-fdas-top-vaccine-regulator-leave-2025-03-31/
6. HHS. HHS Announces Transformation to Make America Healthy Again. Press Release. March 27, 2025.
7. HHS. Fact Sheet: HHS’ Transformation to Make America Healthy Again. HHS.gov (accessed March 27, 2025). https://www.hhs.gov/about/news/hhs-restructuring-doge-fact-sheet.html