The U.S. Food and Drug Administration (FDA) has announced significant leadership changes within its critical drug and biologics regulatory centers. These shifts come on the heels of a turbulent week for the agency, which saw the departure of its former commissioner, Marty Makary. The latest restructuring involves key personnel at the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER), the divisions tasked with overseeing the approval of prescription medicines, vaccines, and other biological products.

Tracy Beth Høeg, who was serving as the acting director of CDER, and Katherine Szarama, the acting director of CBER, are stepping down from their interim roles. While Szarama is expected to continue with the agency in a different capacity, Høeg indicated in a social media post that her departure was a termination. Taking the helm at CDER will be Michael Davis, and Karim Mikhail will assume leadership of CBER. Additionally, Lowell Zeta has been appointed as the acting chief of staff. These organizational changes have been reflected in the FDA’s official website.

This leadership overhaul occurs at a pivotal moment for the FDA, an agency that regulates products contributing significantly to U.S. consumer spending. The recent departure of Commissioner Makary followed reports of potential ousting, adding to a pattern of staff turnover observed within the agency during the current administration. The leadership instability at CDER and CBER is not entirely new, as both centers have experienced multiple acting directors over the past year, highlighting ongoing challenges in maintaining consistent leadership for these vital regulatory functions.

The administration is reportedly working to identify and nominate permanent leaders for these positions, with expectations of naming a commissioner nominee in the coming weeks, pending Senate confirmation. Concurrently, efforts are underway to fill other high-level health positions, including the director of the Centers for Disease Control and Prevention (CDC) and the surgeon general, underscoring a broader focus on reshaping the nation’s public health leadership.