Peter Marks has resigned from his role as Director of the FDA’s Center for Biologics Evaluation and Research (CBER), with some media outlets reporting that Marks was given the choice of resigning or being fired. His final day will be April 5.
In his resignation letter, which has been leaked in full online, Marks emphasized his concerns over efforts to undermine confidence in vaccines and took aim at Secretary of Health and Human Services Robert F. Kennedy Jr. The letter says: “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 given to the BBC, the Department of Health and Human services said that 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.”
Marks was appointed to his position in 2016, but he first joined CBER in 2011, after his work in industry led to an interest in the agency. Speaking in an interview in 2021 about his career, Marks explained: “My first industry role was with Genzyme and involved interacting with the Center for Biologics. The Center had both an applied scientific research component and a regulatory component working with a nifty set of products. It was so interesting to me that, in 2011, I applied for a job there. At the time, gene and cell therapies were becoming very exciting – and, as a hematologist-oncologist, blood products were, of course, of interest to me. The opportunity to have an impact on the development and availability of important medical products was attractive.”
During the COVID-19 pandemic, Marks played a leading role in Operation Warp Speed. He has received the American Society of Hematology Outstanding Service Award and was named by TIME as one of the 100 most influential people in healthcare in 2024.
Numerous scientists and organizations have come forward to express their thanks for Marks’ hard work over the years, and concerns about his departure. The Alliance for Regenerative Medicine described him as a “visionary leader, advocate for rare disease patients, and champion of cell and gene therapy.”
BIO President and CEO John Crowley said, in a statement, “Under the extraordinary leadership of Dr. Peter Marks, the FDA shepherded in a new era of scientific breakthroughs – from new vaccines to curative cell and gene therapies that have strengthened and saved the lives of millions of patients and families.
“The U.S. has long been recognized as the world leader in medical and scientific innovation and regulation, grounded in transparency and scientific rigor. 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.”
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