Peter Marks resigns from FDA under pressure

Peter Marks, M.D., Ph.D. has resigned as director of the Center for Biologics Evaluation and Research (CBER) and retired from federal service.

Dr. Marks resigned on Friday, reportedly after he was called to the Department of Health and Human Services, now helmed by Robert F. Kennedy Jr., and told to choose between quitting or be fired, people familiar with the matter told several media outlets.

Dr. Marks’ resignation, effective April 5, was tendered via two-page letter dated March 28 to acting FDA commissioner Sara Brenner, MD. The letter included criticism of Kennedy’s ant-vaccine policies, with Marks warning that, “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.”

Board certified in internal medicine, hematology and medical oncology, and a fellow of the American College of Physician, Dr. Marks joined the FDA in 2012 as deputy center director for CBER and became director in 2016. 

During his tenure at CBER, Marks was instrumental in carrying out Operation Warp Speed and faciliting access to safe and effective vaccines for COVID, RSV and mpox. He oversaw the approval 22 gene therapies, including the first gene therapy ever to be approved in the U.S. “However, we know that we must do better to expedite the development of treatments for those individual suffering from any one of the thousands of diseases potentially addressable by the advances in molecular medicine over the past decades,” said Marks in his resignation letter, speaking of cell and gene therapies.

Dr. Marks’ exit was met with a considerable amount of dismay from those within the industry (ARM, BIO), with many insiders applauding his leadership while voicing concerns about the future integrity of FDA decisions.

The news comes amid a wave of departures at the FDA, including two senior staff in the Oncology Center of Excellence and Dr. Patrizia Cavazzoni, former head of the Center for Drug Evaluation and Research (CDER), who announced her retirement from the agency in January ahead of Donald Trump’s inauguration. Cavazzoni later rejoined Pfizer as chief medical officer.