Scott Steele was named acting head. Peter Marks left the position last month over what he saw as HHS Secretary Kennedy’s ’misinformation and lies.’
After its top vaccine official left the Food and Drug Administration (FDA), the agency announced Thursday that it has named his replacement.
In an April 1 statement on X, the FDA said Scott Steele would be the acting head of the Center for Biologics Evaluation and Research (CBER), which Peter Marks once led.
Scott Steele, Ph.D. has been named FDA’s Acting Director for the Center for Biologics Evaluation and Research (CBER).
— U.S. FDA (@US_FDA) April 1, 2025
Dr. Steele is a science, technology, and policy professional at FDA with extensive experience in multiple disciplines, including emerging science and technology,…
“Dr. Steele is a science, technology, and policy professional at FDA with extensive experience in multiple disciplines, including emerging science and technology, translational science, public health preparedness, and biodefense and medical countermeasures,” the FDA statement said.
Since 2017, Steele has had multiple roles in the FDA and, most recently, was a senior adviser to CBER’s translational science office, according to the FDA. Before that, he worked on an assignment in the FDA’s Center for Drug Evaluation and Research on policies.
Aside from vaccines, CBER also oversees allergenic products, blood products, and cellular, tissue, and gene therapies.
Late last month, Marks submitted a letter to the FDA’s former acting director, Sara Brenner, saying he would step down in April. His letter cited concerns about how Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. would handle vaccines and other initiatives.
Marks had overseen the agency’s rapid review and approval of COVID-19 vaccines and treatments during the pandemic. Marks was also credited with coming up with the “Operation Warp Speed” name for the effort to quickly develop vaccines during that time period.
“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,” Marks said in his letter.
“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.”
