Amid a dramatic reshaping of the federal healthcare apparatus, the FDA has named an acting leader of its Center for Biologics Evaluation and Research.
Agency adviser Scott Steele, Ph.D., will take over the key center for the time being, the FDA said on a post on X late Monday. Steele has been a full-time adviser to CBER since late 2022, according to his LinkedIn profile. Before that, he advised the FDA's Office of Medical Policy Initiatives from June 2020 to September 2022.
"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 said in the post.
The appointment comes a few days after longtime CBER director Peter Marks, M.D., Ph.D., abruptly resigned. Late last week, Marks authored a resignation letter blasting HHS secretary Robert F. Kennedy, Jr. for "misinformation and lies" surrounding vaccine efficacy and safety.
The former CBER official wrote that he would serve until April 5, though his profile on the FDA's website has already been taken offline. His departure is one of thousands taking place at federal health agencies under the Trump administration.
Steele replaces Julie Tierny, who was tapped as acting CBER director amidst Marks' resignation. Tierny, along with Peter Stein, director of the Office of New Drugs, and Hilary Marston, the FDA's chief medical officer, have been put on administrative leave, Politico reports.
Marks' sudden exit drew pushback from the biopharma industry, with Biotechnology Innovation Organization CEO John Crowley saying in a statement his organization is "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."
BIO did not immediately respond to Fierce Pharma's request for comment on Steele's appointment as acting CBER director.
CBER is one of the main pillars of the FDA, overseeing the regulation of biological and related products such as vaccines and cell and gene therapies for human use.
During his tenure at the head of the division, Marks developed a reputation as an advocate for the FDA's accelerated approval pathway for rare diseases, especially as it tied into gene therapies. The outgoing FDA official also played a key role in the U.S.' Operation Warp Speed effort to hasten the development of COVID-19 vaccines.
Steele, for his part, seems to have largely stayed out of the public eye during his time so far at the FDA. As for what the new acting director's priorities may be, Steele said in a 2018 "biographical sketch" for the agency that he has previously explored approaches to foster research collaborations and hasten the development and approval of medical products, suggesting that he too could be a proponent for expedited approvals.
Steele also served as a White House adviser on science and technology under George W. Bush, Reuters reported this week.
The acting director is slated to lead CBER at a tumultuous moment for the FDA, and for federal health agencies in general, thanks to sweeping efforts from the Trump administration to reduce government spending via layoffs.
Last week, the administration revealed plans to cut 10,000 jobs at the Department of Health and Human Services (HHS), which will so far include 3,500 layoffs of full-time workers at the FDA and 1,200 more at the National Institutes of Health (NIH).
Apart from the administration-mandated purge of federal staffers, several other prominent FDA officials have stepped down since the start of the year, including Patrizia Cavazzoni, M.D., who left her post as head of the FDA’s Center for Drug Evaluation and Research (CDER) in mid-January.
In the wake of Marks' exit from CBER, multiple news outlets have reported that the top vaccine official was given an ultimatum to either step aside or be pushed out of his role at the FDA.