Amid Chaos and Confusion, Scott Steele Replaces Peter Marks at FDA
FDA names Scott Steele as interim director of FDA’s CBER
Late last week, Peter Marks resigned from the U.S. FDA’s Center for Biologics Evaluation and Research (CBER) after being told to resign or be fired. Julie Tierney, Marks’ deputy, took over the position before she was placed on administrative leave. Steele has been a senior advisor to the CBER since late 2022. The FDA’s Chief Medical Officer, Hilary Marston, also stepped down, as well as Peter Stein, director of CDER’s Office of New Drugs, and Ross Segan, director of the medical device center’s Office of Product Evaluation and Quality.
Whereas Marks held an MD and PhD, Steele holds a PhD in molecular biology (Tierney was an attorney). The previous director of CBER, Karen Midthun, also was an MD.
Robert F. Kennedy, Jr., HHS Secretary, has recently conducted mass layoffs, which started Tuesday at the Centers for Disease Control and Prevention (CDC) and at the FDA. The plan is to cut 10,000 jobs at HHS. In total, between earlier layoffs and early retirement offers, HHS is expected to drop its headcount from 82,000 to 62,000.
Kenney has argued that he wants to slash connections between biopharma and public health agencies. Although it makes a certain kind of sense to avoid conflicts of interest (not something the Trump administration is known to spend much time and energy avoiding), it makes little sense to have people with no biopharma industry experience regulating the biopharma industry.
Steele’s career is a mix of academic and government positions but he has never worked directly in biopharma. Steel’s resume indicates he began in 2003 as a Research Associate at the Woodrow Wilson School of Public and International Affairs and The Program on Science and Global Security at Princeton University before moving to the FBI, then back into academia at George Washington University. The most recent position is Director of Regulatory Science Programs, Clinical and Translational Science Institute at the University of Rochester Medical Center in Rochester, NY.
Marty Makary just took over as Commissioner of the FDA late last amid the chaos and confusion. His first official act was the forced removal of Marks, something apparently he and Kennedy had agreed to do. Somewhat puzzling is it appeared Makary’s swearing in was so secret that few if anybody at the FDA was aware he was the new commissioner, including Marks, who addressed his scathing resignation letter to Sara Brenner, who was the acting commissioner.
To date, 23 states and the District of Columbia are suing HHS and Kennedy, arguing that the terminations and cuts of $11 billion in public health funding are “harmful” and “unlawful.” The lawsuit was filed in federal court in Rhode Island.
In part, the lawsuit stated, “These termination notices and substantially similar subsequent notices immediately triggered chaos for State and local health jurisdictions. If the funding is not restored, key public health programs and initiatives that address ongoing and emerging public health needs of Plaintiffs will have to be dissolved or disbanded. The result of these massive, unexpected funding terminations is serious harm to public health.”