FDA fires top drug chief

The U.S. Food and Drug Administration removed Tracy Beth Hoeg as acting director of its drug center on Friday and installed deputy Michael Davis in the role, according to Hoeg’s public statement, internal agency communications reported by CNBC and changes posted on the FDA’s website. Hoeg said on X that she had been fired and did not know who made the decision or why. The move came days after FDA Commissioner Marty Makary left the agency and Kyle Diamantas was put in place as acting commissioner, according to Reuters and CNBC. The personnel changes also reached the biologics center and the commissioner’s office, extending a week of leadership turnover at the agency. ### Who was removed, and who replaced her? Tracy Beth Hoeg was serving as acting director of the Center for Drug Evaluation and Research, the FDA division that regulates prescription and over-the-counter drugs, including reviews of new medicines. Reuters reported on May 16 that Hoeg was fired Friday, citing her social media post, and that Michael Davis had replaced her as acting director. (whbl.com) Michael Davis had been CDER’s deputy center director for about a year before the change, Reuters reported. An FDA biography describes Davis as deputy center director at CDER, confirming his senior role inside the drug-review operation before his elevation. ### What did Hoeg say about her dismissal? (whbl.com) Hoeg said in a post on X late Friday that she had been fired from the FDA. The New York Times reported that Hoeg said she did not know who had fired her or why, and did not know whether Health Secretary Robert F. Kennedy Jr. knew about the decision. (whbl.com) Reuters reported it had first said Hoeg was expected to leave the FDA on Friday, before her public statement confirmed that she considered the move a firing. CNBC separately reported that an internal memo said Hoeg would leave her role, while Hoeg herself wrote that she had been fired. (nytimes.com) ### Which other FDA jobs changed hands this week? Katherine Szarama, the acting head of the Center for Biologics Evaluation and Research, was also removed from that job, according to a memo seen by CNBC. CNBC reported that Karim Mikhail would replace Szarama at CBER and that Szarama would remain at the agency. Reuters also reported that Mikhail, previously an FDA adviser, had been named acting director of the biologics center after Vinay Prasad left that post in April. (whbl.com) Lowell Zeta was named acting chief of staff, replacing Jim Traficant, who will remain in an advisory role, Reuters reported. CNBC said the FDA’s organization chart had been updated by Friday night to reflect the changes. ### How does this connect to Marty Makary’s exit? Marty Makary resigned as FDA commissioner on May 12, according to CNBC and Reuters reporting surfaced in other outlets. (cnbc.com) CNBC reported that President Donald Trump said Kyle Diamantas, previously the FDA’s top food official, would serve as acting commissioner while the administration looked for a permanent nominee. (whbl.com) CNBC reported that the administration hoped to name a permanent commissioner nominee within weeks and that the post would require Senate confirmation. That leaves the FDA’s top job, the drug center and the biologics center all under acting leadership for now. (cnbc.com) ### Why does the drug center matter to companies and patients? The Center for Drug Evaluation and Research is the FDA unit that reviews applications for new drugs and oversees many prescription and over-the-counter products. Hoeg had led the office since December, CBS reported, putting her in charge of one of the agency’s most consequential regulatory divisions. (cnbc.com) Reuters reported that the FDA has lost thousands of employees since President Donald Trump took office through firings and voluntary departures. Any effect on review timelines or company behavior remains uncertain, but the immediate next facts are clear: Davis is now leading CDER on an acting basis, Mikhail is leading CBER, and the administration is searching for a permanent FDA commissioner nominee who would face Senate confirmation. (cbsnews.com) (whbl.com)