Following the dramatic late-night resignation of Peter Marks last Friday, Steele, a senior advisor to the division, takes the reins in a department inside an agency beset by cuts, layoffs, and confusion.
Five days after Peter Marks announced his resignation as head of the FDA’s Center for Biologics Evaluation and Research, the agency has named an interim successor, Scott Steele.
Since late 2022, Steele had been the senior advisor to the center, better known as CBER. He will be taking over from Julie Tierney, Marks’ deputy who temporarily took over the role before being let go herself, according to reporting from Politico.
Steele is an atypical person for the position in that he doesn’t have a medical degree. Marks held both a Ph.D. and an M.D., and Karen Midthun, who served before Marks, was an M.D. as well.
Steele is a Ph.D. trained in molecular biology. He has bounced between academic and government positions for his entire career. He has never been directly employed by a biopharma company, according to his resume. Robert F. Kennedy Jr., the newly anointed secretary of Health and Human Services overseeing the staffing changes at FDA, has been adamant about cutting ties between biopharma and public health agencies, and FDA officials often work in industry before or after their government service. Patrizia Cavazzoni resigned as the director of FDA’s Center for Drug Evaluation and Research (CDER) just before Donald Trump was sworn in again as president; she now serves as chief medical officer at Pfizer.
Steele served as the executive director of the President’s Council of Advisors on Science and Technology under the George W. Bush administration before starting a nearly 15-year stint as a professor and administrator at the University of Rochester. He returned to government as an advisor at the FDA’s Office of Medical Policy Initiatives in 2020, before joining CBER.
Steele is stepping into a maelstrom of recent political intrigue. His predecessor Marks was an outspoken advocate for vaccine policy who committed to working with the new administration, despite Kennedy’s history of vaccine denialism. He resigned late Friday night after being given the choice to do so or be fired.
Marks wrote in his resignation letter that despite his willingness to work with the Secretary on vaccine safety, “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.”
Also stepping down in recent days is the FDA’s Chief Medical Officer Hilary Marston. The Office of the Chief Medical Officer (OCMO) supports medical product development and promotes patient safety.
“I am sad that this chapter is coming to an end and very sorry for others experiencing the same,” Marston wrote in a LinkedIn post announcing her stepping down.
The loss of these and other FDA leaders, including Peter Stein, the director of CDER’s Office of New Drugs, which oversees drug development and marketing, Ross Segan, the director of the medical device center’s Office of Product Evaluation and Quality, which oversees medical devices review and post market monitoring, and even Marks’ deputy, Celia Witten is just the tip of the iceberg. Some 3,500 layoffs total are expected to unfold at the FDA of the 10,000 employees reportedly being cut across HHS. Numerous FDA departments have been hit, including its public records and communications team, internal agencies focused on older adults and people with disabilities, HIV research teams and leadership supervising the country’s response to the bird flu epidemic.
Reporting has described scenes of disorder and chaos, where FDA employees reported to work to find their keycards turned off. Robert Califf, the former FDA commissioner under the Biden administration, wrote on LinkedIn that “The FDA as we’ve known it is finished with most of the leaders with institutional knowledge and a deep understanding of product development and safety no longer employed.”
