FDA drug center director removed in latest shake-up

FDA Commissioner Marty Makary resigns

Food and Drug Administration (FDA) Commissioner Marty Makary is resigning from his position Tuesday, a White House official told Fox News. The official said that Makary's resignation has to do with "process at the FDA" and not a specific issue, and said there is "no bad blood" between President Donald Trump and the outgoing commissioner. Health and Human Services Secretary Robert F. Kennedy Jr. pushed for Makary's resignation, according to the White House official. 

WASHINGTON - A Food and Drug Administration official involved in reviewing the safety of antidepressants, COVID-19 vaccines, and other widely used treatments has been removed from her position overseeing the agency’s drug program.

According to an email sent to agency staff on Friday and obtained by The Associated Press, Dr. Tracy Beth Hoeg will be replaced as acting director of the FDA’s drug center by Dr. Mike Davis, who has been serving as deputy director.

FDA drug center director Tracy Beth removed

What they're saying:

Hoeg said in a social media post late Friday that she was "fired," from the agency.

"Today marked 6 months as head of CDER at @FDA & today I was fired," she wrote on May 15, adding. "I’m incredibly grateful to have had this opportunity to serve this country & proud of the work we did. FDA staff are smart, talented, supportive & don’t get enough credit." 

She concluded, "I learned so much & leave with no regrets." 

Hoeg’s rise to FDA drug center director

The backstory:

Hoeg, who is closely aligned with Health Secretary Robert F. Kennedy Jr., had been leading FDA’s drug program since December.

Hoeg was promoted from serving as a special assistant to overseeing the agency’s largest center, responsible for regulating most U.S. prescription and over-the-counter drugs.

Dr. Tracy Beth Hoeg during a meeting of the CDC's Advisory Committee On Immunization Practices at the Center for Disease Control (CDC) headquarters in Atlanta, Georgia, on Thursday, Dec. 4, 2025. (Credit: Megan Varner/Bloomberg via Getty Images)

Since arriving at the FDA last March, Hoeg led investigations into the safety of injectable RSV drugs for children, antidepressants and COVID-19 vaccinations.

Hoeg was instrumental in the Trump administration’s recent effort to drop a number of federally recommended shots for children, including those for the flu and hepatitis B at birth. Those changes have been temporarily blocked by a federal judge in Boston, though the administration plans to appeal the decision.

Last shake-up at agency

Big picture view:

Hoeg’s departure is the latest in an ongoing shake-up at the regulatory agency.

Last week, Marty Makary, the head of the Food and Drug Administration, resigned just over one year since taking the job.  

RELATED: Trump's FDA commissioner, Dr. Marty Makary, to resign

A White House official told FOX News that Makary’s resignation had to do with "process at the FDA" and that there was "no bad blood" between Makary and President Donald Trump. 

Last month, Dr. Vinay Prasad, the agency’s vaccine and biotech chief, also stepped down following intense criticism from drugmakers, patients and investors.