Peter Marks Resigns as CBER Director

Peter Marks, MD, PhD, head of FDA’s Center for Biologics Evaluation and Research (CBER), announced Friday that he will resign from the agency, effective April 5. His resignation comes amid a broader shakeup in the nation’s health agencies led by Secretary of Health and Human Services Robert F. Kennedy, Jr. 

In a letter to acting FDA Commissioner Sara Brenner, Marks referenced several of his significant contributions to public health. He led CBER since 2016, where he oversaw the regulation of biological products, including vaccines, gene therapies, blood products and cellular and tissue-based therapies. During his tenure, the U.S. saw a rapid expansion in the number of FDA-approved cell and gene therapies. FDA also updated policies that expanded blood donor eligibility while maintaining donor and patient safety. 

During the first Trump administration, Marks played a key role in establishing Operation Warp Speed, an interagency initiative that began early in the pandemic with the goal of accelerating the development of candidate COVID-19 vaccines and other therapies for COVID-19. Throughout the pandemic, Marks provided unprecedented access and support to the blood community, expediting the delivery of COVID-19 convalescent plasma to patients as a first-line treatment early in the pandemic. 

“Though I will regret not being able to be part of future work at the FDA, I am truly grateful to have had the opportunity to work with such a remarkable group of individuals as the staff at FDA and will do my best to continue to advance public health in the future,” Marks wrote in his resignation letter. 

On Tuesday, FDA appointed Scott Steele, PhD, acting director. 

AABB Statement