FDA drug chief Tracy Høeg exits

Dr. Tracy Beth Høeg, the acting head of the U.S. Food and Drug Administration’s drug center, left the agency on May 16 after saying she was fired. An internal email obtained by The Associated Press said Høeg would be replaced as acting director of the Center for Drug Evaluation and Research, or CDER, by deputy director Mike Davis. Høeg wrote on X late Friday, “today I was fired,” and added that she had learned “so much” and left “with no regrets.” The move came days after FDA Commissioner Marty Makary resigned and weeks after vaccines and biologics chief Vinay Prasad stepped down. ### Which job did Tracy Beth Høeg hold at the FDA? The FDA said on December 3, 2025, that Høeg had been appointed acting director of CDER, the center that regulates most prescription and over-the-counter drugs in the United States. The agency described her as a physician and epidemiologist who had joined the FDA as a senior adviser for clinical sciences in the Office of the Commissioner and the Center for Biologics Evaluation and Research. (abcnews.com) CDER is the FDA’s largest center and is responsible for reviewing applications for new drugs, according to agency materials and reports on Høeg’s appointment and exit. ABC, citing AP reporting, said Høeg had been leading the drug program since December after a rapid rise under Makary. (fda.gov) ### What exactly did Høeg say about her departure? Høeg said in a social media post late Friday that she was “fired,” according to AP and STAT. STAT reported that she wrote, “today I was fired. … I learned so much & leave with no regrets.” AP separately reported the same account and said the agency email named Davis as her replacement. (fda.gov) Mike Davis was already serving as CDER deputy director, according to the FDA’s leadership page. Reuters, as cited in other outlets, had reported earlier that Høeg was expected to leave the agency after Makary’s resignation. ### Why was Høeg a closely watched official? Since arriving at the FDA in March 2025, Høeg had led or helped lead reviews involving COVID-19 vaccines, antidepressants and other therapies, according to AP. (abcnews.com) The same report said she had drawn attention during the pandemic as a critic of masking, school closures and vaccine mandates before joining the government. (fda.gov) ABC’s AP report said Høeg had been involved in scrutiny of injectable RSV drugs for children, antidepressants and COVID-19 vaccinations. Those reviews reflected issues she had publicly focused on before entering government, the report said. ### How does this fit into the broader FDA turnover? (abcnews.com) Marty Makary resigned as FDA commissioner on May 12, President Donald Trump said, after clashes with White House and health advisers, according to Reuters. AP reported that Høeg’s departure followed Makary’s exit and Vinay Prasad’s departure from the vaccines and biotech post last month. (abcnews.com) On May 15, the agency also announced that Karim Mikhail would take over as acting director of the vaccines center, according to AP reporting carried by multiple outlets. CNBC reported, citing a memo, that the FDA was shuffling its top drug and biologics regulators as the Trump administration worked to fill several health vacancies. (msn.com) ### Who is taking over now? The internal email obtained by AP said Mike Davis would become acting director of CDER. The FDA’s leadership page lists Michael Davis, M.D., Ph.D., as deputy center director of CDER. Karim Mikhail was named acting director of the vaccines center on May 15, AP reported. (abcnews.com) The next formal confirmation of the FDA’s leadership lineup is likely to come through updated agency webpages, internal staff notices or any White House and Health and Human Services announcements naming permanent successors.