FDA Names Acting Heads of Drug and Biologics Centers as Leadership Turnover Widens

The US Food and Drug Administration has new acting leaders at its drug and biologics centers and in the commissioner's office, after the acting head of the drug center was fired days after Commissioner Marty Makary resigned, according to reports from Reuters and the Regulatory Affairs Professionals Society (RAPS).

Tracy Beth Hoeg, acting director of the Center for Drug Evaluation and Research (CDER), was fired on Friday, May 15, according to her social media post, Reuters reported in a story read via 92.7 FM WHTC. Reuters said Hoeg announced her departure in a post on X late that day.

Who is in charge now

In an email to staff that Friday, acting Commissioner Kyle Diamantas announced that Michael Davis would serve as acting CDER director, Karim Mikhail as acting director of the Center for Biologics Evaluation and Research (CBER), and Lowell Zeta as acting chief of staff, RAPS reported on May 21.

Davis had been CDER's deputy director for about a year, according to Reuters. Mikhail had been working at the FDA as an adviser; the CBER post was left open when Vinay Prasad departed in April. Zeta had been deputy commissioner and special counsel. He replaces Jim Traficant, who had been chief of staff and, according to a Department of Health and Human Services official cited by Reuters, is staying on in an advisory role.

Hoeg told MD Reports that she first learned of her firing from news media reports and thought they were rumors until two FDA officials came to her office demanding that she resign or be fired, RAPS reported. Bloomberg News also reported that Deputy Chief of Staff Sam Doran and Chief AI Officer Jeremy Walsh left the agency the same week, according to RAPS.

A wider shake-up

Diamantas, previously the FDA's deputy commissioner for food, replaced Makary as acting commissioner the previous week. Reuters said Makary left after weeks of clashing with top White House and health advisers over decisions that drew criticism, including on drug approvals. It said the departures come amid a wider shake-up of an agency that has lost thousands of people through firings and voluntary departures since President Donald Trump took office.

Hoeg, an epidemiologist and sports physician, helped lead the effort to cut the number of recommended childhood vaccinations from 17 to 11 in January, a move a US court has put on hold, Reuters reported. The White House this year named Chris Klomp as the No. 2 to Health Secretary Robert F. Kennedy Jr., and he has helped bring in new nominees for top health posts, the news agency said.

The leadership changes came as the agency continued other work. RAPS reported that the FDA published minutes from a May 15 meeting with drug industry groups in which it said it had concluded technical negotiations on the next Prescription Drug User Fee Amendments, or PDUFA VIII. The device center is also taking proposals until June 18 for its Experiential Learning Program, which lets CDRH staff make training visits to learn about technologies in development, RAPS said.