REFILE-FDA drug center head expected to leave after commissioner's exit, sources say

* Hoeg's departure comes amid broader shakeup of ​health agency

* Hoeg helped lead changes to childhood vaccination schedule

* Drug center has had five directors since last year

WASHINGTON, May 15 (Reuters) - The acting head ​of ‌the U.S. Food and Drug Administration's drug center, Tracy Beth Hoeg, is expected to leave the agency just days after Commissioner Marty Makary resigned, according to three ⁠people familiar with internal planning. Hoeg, an epidemiologist and sports physician who cast doubt ⁠on COVID vaccines during the pandemic, 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. Those childhood vaccine schedule changes were put on hold as part of a lawsuit addressing the overhaul of vaccine policies under Health Secretary Robert F. Kennedy.

"HHS and FDA do ​not comment ‌on personnel matters," HHS spokeswoman Emily Hilliard said in a statement.

The decision, while expected, has not yet been finalized. Hoeg was not immediately available for comment.

OTHER DEPARTURES EXPECTED

Hoeg's departure would come amid a broader shake-up of the health department. The White House has exerted more control over the department in recent months as polls show Kennedy's efforts to rewrite U.S. vaccine policy could prove costly with voters in November's midterm ​elections that will decide whether Republicans retain control of Congress.

The White House installed Chris Klomp as Kennedy's No. 2, and Klomp has since helped ‌bring in a slate of more conventional nominees for top health positions, such as director of the Centers for Disease Control and Prevention and Surgeon General.

Since Makary's resignation on Tuesday, Klomp has ‌been pushing to rid the FDA of controversial appointees and replace them with more traditional picks, according to two of the sources.

A number of lower-level FDA officials - most of whom were brought in by Makary - are also expected to depart, including chief of staff Jim Traficant; deputy chief ​of staff Samuel Doran; and associate director of policy and research strategy Sanjula Jain-Nagpal, the sources said.

Traficant, Doran and Jain-Nagpal were not immediately available for comment.

LEADERSHIP MARKED BY ‌CONTROVERSY Makary's leadership of the FDA was marked by tumult and controversy. Thousands of experienced career employees left the agency last year as part of Elon Musk's Department of Government Efficiency purge, and top leaders were forced out. Hoeg, the fifth person to run the Center for Drug Evaluation ⁠and Research in ⁠the 15 months of President Donald Trump's second term, was in the job for five months.

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, a ​move that was strongly objected to by experts.

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. (Reporting by Yasmeen Abutaleb in Washington and Michael Erman in New York; Editing by Caroline Humer and Bill Berkrot)

Merck

Sanofi

Astrazeneca