FDA appoints Scott Steele Acting Director of CBER amid leadership shift

USA—The U.S. Food and Drug Administration (FDA) has appointed Scott Steele, Ph.D., as the acting director of its Center for Biologics Evaluation and Research (CBER).

This move follows the sudden resignation of longtime CBER Director Peter Marks, M.D., Ph.D., who had been a key figure in the development of COVID-19 vaccines and an advocate for the accelerated approval of gene therapies. 

Dr. Steele, a seasoned professional in science, technology, and policy, has been serving as a senior advisor to CBER since late 2022.

 Previously, he served as an advisor to the FDA’s Office of Medical Policy Initiatives from June 2020 to September 2022.

His extensive experience spans emerging science and technology, translational science, public health preparedness, and biodefense and medical countermeasures.

Steele replaces Julie Tierny, who briefly held the acting director position after Marks’ resignation.

Marks’ departure was marked by controversy, as he criticized Health and Human Services Secretary Robert F. Kennedy, Jr., for spreading misinformation about vaccine efficacy and safety.

Marks’ resignation letter highlighted his commitment to serving until April 5, although his profile was quickly removed from the FDA’s website.

His exit is part of a broader wave of changes at federal health agencies, including thousands of layoffs under the Trump administration.

 The biopharma industry has expressed concern over Marks’ departure, with the Biotechnology Innovation Organization (BIO) stating that the loss of experienced leadership could erode scientific standards and impact the development of new therapies.

Despite these challenges, Steele’s background suggests that he may support expedited approvals, having explored ways to foster research collaborations and accelerate the development of medical products.

Steele’s appointment comes at a tumultuous time for the FDA, with significant restructuring efforts underway.

 The Trump administration has announced plans to cut 10,000 jobs at the Department of Health and Human Services, including layoffs at the FDA and the National Institutes of Health.

Additionally, several prominent FDA officials have recently stepped down, further complicating the agency’s operations.

As acting director, Steele faces the challenge of leading CBER during this period of upheaval.

CBER plays a crucial role in regulating biological products, such as vaccines and gene therapies, making Steele’s leadership pivotal for the future of these critical areas.

While Steele’s tenure as acting director is uncertain, his experience and policy background position him to navigate these complex issues.

In the past, Steele has also served as a White House adviser on science and technology under George W. Bush, providing him with a broad perspective on national health and technology policies.

His academic background includes a Ph.D. in molecular biology from Princeton University, which complements his extensive experience in government and academia.

As the FDA continues to evolve under new leadership and amidst significant organizational changes, Steele’s role will be closely watched.

His ability to balance the need for regulatory oversight with the push for innovative medical products will be crucial in shaping the future of biologics and related therapies in the U.S.

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