US Health Department Names Permanent Directors for FDA Drug and Vaccine Centers

The US Department of Health and Human Services (HHS) has formalized the leadership of two critical Food and Drug Administration (FDA) review centers, appointing their acting heads to permanent director roles. The announcement on Tuesday ends a period of interim leadership at the units responsible for regulating medicines, vaccines, and other biologic products.

Michael Davis will now serve as the director of the Center for Drug Evaluation and Research (CDER), while Karim Mikhail takes over the top post at the Center for Biologics Evaluation and Research (CBER). Both had been serving in an acting capacity. Davis had been CDER's deputy director for roughly a year before assuming the acting director role in May, while Mikhail had been an adviser at the FDA prior to his acting appointment.

In a related move, the agency has also named Jared Seehafer as its first deputy commissioner for technology and artificial intelligence. Additionally, Bret Koplow, who was serving in an acting role, has been appointed as the director of the Center for Tobacco Products.

These appointments come at a time when the FDA is navigating significant internal challenges. The agency has faced an exodus of experts and top talent, including division heads, with more than 3,000 staff departures over the past year. This has contributed to plummeting morale and placed pressure on the agency to rebuild confidence among industry and public-health groups.

The leadership changes follow last month's nomination of White House policy aide Heidi Overton to lead the FDA. The agency has been dealing with fallout from widespread job cuts initiated by Health Secretary Robert F. Kennedy Jr., as well as ongoing debates over vaccines, drug approvals, and other regulatory matters.