The acting head of the U.S. Food and Drug Administration's drug center, Tracy Beth Hoeg, was fired Friday, according to her social media post, and replaced by deputy Michael Davis, the FDA's website shows.
Tracy Beth Hoeg, M.D., Ph.D., U.S. Food and Drug Administration director of the Center for Drug Evaluation and Research, participates in a Dec. 4 meeting of the Advisory Committee on Immunization Practices (ACIP) to discuss childhood vaccine schedule at the Centers for Disease Control and Prevention in Atlanta, Georgia.
Reuters was first to report Hoeg was expected to leave the FDA on Friday, just days after Commissioner Marty Makary was replaced.
Kyle Diamantas, who was FDA deputy commissioner for food, replaced Makary, who left after weeks of clashing with top White House and health advisers over decisions that drew criticism regarding drug approvals and other issues.
Davis, the new acting director of the Center for Drug Evaluation and Research, was the deputy director of CDER for about a year.
Changes at the FDA
Makary's leadership of the FDA was marked by tumult and controversy.
People are also reading…
The departures of Hoeg and Makary came amid a wider shakeup of the agency, which lost thousands of people through firings and voluntary departures since President Donald Trump took office. Thousands of experienced career employees left the agency last year as part of billionaire Elon Musk's Department of Government Efficiency purge, and top leaders were forced out.
As part of a move to tighten control on the health agency, the White House this year named Chris Klomp as Health Secretary Robert F. Kennedy Jr.'s No. 2. He since helped bring in new nominees for top health positions, such as director of the Centers for Disease Control and Prevention and surgeon general.
Since Makary's resignation Tuesday, Klomp pushed to rid the FDA of controversial appointees and replace them with more traditional picks, according to two sources.
Karim Mikhail was named acting director of the Center for Biologics Evaluation and Research, or CBER, the FDA's website shows. Vinay Prasad left that job last month. Mikhail had worked at the FDA as an adviser.
Lowell Zeta, who was deputy commissioner and special counsel, was named acting chief of staff. He replaces Jim Traficant, who was the chief of staff and, according to a Department of Health and Human Services official, will stay on in an advisory role.
Hoeg's tenure at FDA
Hoeg, who announced her departure via a social media post late Friday, is an epidemiologist and sports physician who cast doubt on COVID-19 vaccines during the pandemic.
She helped lead the effort to overhaul the U.S. childhood vaccination schedule by reducing the number of recommended shots from 17 to 11 in January, though a U.S. court put that move on hold.
She considered a plan to change the label of COVID-19 vaccines to say the risks outweighed the benefits for men ages 12 to 24 because of the risk of a relatively rare heart-related side effect; experts strongly objected to the potential move.
She initiated safety questions over approved protective RSV treatments for infants from Merck, Sanofi and AstraZeneca.
She also disagreed with FDA scientists who recommended approving a Type 1 diabetes drug from Sanofi, prompting the company to ask the FDA to remove the medication, teplizumab, from a pilot program aimed at speeding drug approvals.
Hoeg, the fifth person to run the Center for Drug Evaluation and Research in the 15 months of Trump's second term, was in the job for five months.
 ___
This version corrects the spelling of Tracy Beth Hoeg's first name.
Reporting by Anusha Shah in Bengaluru, Michael Erman in New York and Yasmeen Abutaleb in Washington, D.C.
