FDA Leadership Shakeup: Steele Takes Helm at CBER Amid Industry Concerns

In a significant restructuring of federal healthcare leadership, the FDA has appointed Scott Steele, Ph.D., as the acting director of its Center for Biologics Evaluation and Research (CBER). This move comes in the wake of Peter Marks' abrupt resignation, marking a turbulent period for the agency amidst widespread changes in the federal health sector.

Steele's Appointment and Background

Scott Steele, a science, technology, and policy professional at the FDA, brings extensive experience in emerging science and technology, translational science, public health preparedness, and biodefense to his new role. Having served as a full-time adviser to CBER since late 2022, Steele's appointment was announced by the FDA on social media platform X.

Prior to his advisory role at CBER, Steele counseled the FDA's Office of Medical Policy Initiatives from June 2020 to September 2022. His background also includes a stint as a White House adviser on science and technology during the George W. Bush administration, highlighting his broad experience in both scientific and policy arenas.

Industry Reactions and Concerns

The sudden leadership change at CBER has sparked concern within the biopharmaceutical industry. John Crowley, CEO of the Biotechnology Innovation Organization (BIO), expressed apprehension about the potential impact on scientific standards and therapy development. In a statement, Crowley noted, "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."

Broader FDA and HHS Restructuring

Steele's appointment is part of a larger reshaping of federal health agencies under the current administration. The Department of Health and Human Services (HHS) is facing significant job cuts, with plans to eliminate 10,000 positions. This includes 3,500 layoffs at the FDA and 1,200 at the National Institutes of Health (NIH).

The FDA itself is experiencing a wave of departures and administrative changes. Julie Tierny, initially tapped as acting CBER director following Marks' resignation, has been placed on administrative leave along with Peter Stein, director of the Office of New Drugs, and Hilary Marston, the FDA's chief medical officer. These developments follow the earlier departure of Patrizia Cavazzoni, M.D., who left her position as head of the FDA's Center for Drug Evaluation and Research (CDER) in mid-January.

As the pharmaceutical industry grapples with these sweeping changes, all eyes will be on Steele and the FDA to maintain the agency's crucial role in overseeing biological product regulation and advancing public health initiatives.