The U.S. Food and Drug Administration is undergoing another round of leadership changes at its top drug and biologics divisions, according to a memo obtained by CNBC. The moves come just days after the resignation of former FDA commissioner Marty Makary and reflect ongoing turnover at the agency under the second Trump administration.
Acting director of the Center for Drug Evaluation and Research Tracy Beth Høeg and acting director of the Center for Biologics Evaluation and Research Katherine Szarama are stepping down from their roles, the memo states. These divisions oversee regulation of prescription drugs, including pills and vaccines, which together account for roughly 20 percent of U.S. consumer spending.
Szarama will remain at the agency in another capacity, according to the memo. Høeg, however, posted on X that she had been fired. Michael Davis will take over as acting director at CDER, while Karim Mikhail will replace Szarama at CBER. Lowell Zeta has been named acting chief of staff. An updated organization chart on the FDA website reflected the changes as of Friday night.
The shakeup caps a tumultuous week at the agency. Makary resigned following reports that President Donald Trump sought to remove him from the post. The FDA has experienced repeated leadership turnover since January, with multiple acting directors cycling through both CDER and CBER.
Davis becomes the latest in a string of officials to lead CDER since the start of the year. CBER has seen similar flux, including the brief return of Vinay Prasad, who departed again after a series of controversies. A senior administration official told CNBC this week that the Trump administration hopes to name a permanent commissioner nominee within weeks, though that individual would still require Senate confirmation.
"The two divisions are responsible for regulating prescription drugs, including pills and vaccines," the memo noted, underscoring the scope of the affected offices.
Health vacancies elsewhere in the administration remain unfilled, including the director position at the Centers for Disease Control and Prevention and the office of the surgeon general. Officials have described the FDA changes as part of a broader effort to stabilize leadership at agencies handling critical public health functions.
According to the memo, the transitions were effective immediately. An earlier version of the CNBC report incorrectly identified the new appointees' roles, prompting a correction that clarified Davis would lead CDER and Mikhail would head CBER.
Industry observers have noted that frequent leadership shifts can affect review timelines for new drug applications and vaccine approvals. The FDA regulates products that touch nearly every American household, from everyday medications to biologics used in cancer treatment and other serious conditions.
Trump administration officials have not publicly detailed the reasons behind the latest departures. Høeg's statement on X stands as the most direct comment from one of the departing leaders. Szarama's continued presence at the agency suggests the move at CBER was an internal reassignment rather than a full exit.
The agency has struggled with retention challenges since the start of the current administration, with several high-profile departures reported in recent months. A new permanent commissioner, once nominated and confirmed, would be tasked with charting a steady course amid these transitions.
Further personnel announcements are expected in the coming weeks as the administration works to fill remaining health-related posts. The FDA's regulatory reach continues to influence pharmaceutical development, vaccine policy, and consumer product safety nationwide.
