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Stock Markets May 16, 2026 12:58 PM

Acting FDA Drug Center Chief Reported Likely to Leave Following Commissioner's Resignation

Tracy Beth Hoeg's exit would follow a broader shake-up at the Health Department amid contested vaccine policy changes

By Leila Farooq

The acting director of the U.S. Food and Drug Administration's drug center, Tracy Beth Hoeg, is expected to depart the agency days after the resignation of FDA Commissioner Marty Makary, according to multiple people familiar with internal planning. Hoeg, an epidemiologist and sports physician who criticized COVID vaccines during the pandemic, was a key figure in a controversial effort to trim the childhood vaccination schedule earlier this year. That schedule revision has been paused amid a lawsuit challenging vaccine policy changes led by Health Secretary Robert F. Kennedy. The Health and Human Services Department declined to comment on personnel matters.

Acting FDA Drug Center Chief Reported Likely to Leave Following Commissioner's Resignation

Key Points

  • Tracy Beth Hoeg, acting head of the FDA's drug center, is expected to depart the agency shortly after Commissioner Marty Makary's resignation (impacts healthcare regulation).
  • Hoeg, an epidemiologist and sports physician who raised questions about COVID vaccines during the pandemic, led an effort to reduce the childhood vaccination schedule from 17 to 11 shots in January (impacts public health policy and immunization programs).
  • The childhood vaccine schedule changes have been paused as they are subject to a lawsuit challenging the vaccine policy revisions promoted by Health Secretary Robert F. Kennedy (impacts legal and regulatory uncertainty in the health sector).

(Refiles Friday story to correct spelling of acting head's first name to Tracy from Tracey in first paragraph)

WASHINGTON, May 15 - The acting head of the Food and Drug Administration's drug center, Tracy Beth Hoeg, is expected to leave the agency, according to three people familiar with internal planning. The reported move would follow the resignation of FDA Commissioner Marty Makary by a matter of days.

Hoeg, who trained as an epidemiologist and practises as a sports physician, drew attention during the COVID-19 pandemic for voicing doubts about COVID vaccines. Earlier this year she helped lead an initiative to revise the United States childhood vaccination schedule, cutting the recommended number of shots from 17 to 11 in January. That overhaul has since been placed on hold as part of a lawsuit tied to broader changes to vaccine policy under Health Secretary Robert F. Kennedy.

Asked about personnel developments, the Department of Health and Human Services provided a brief statement. HHS spokeswoman Emily Hilliard said, "HHS and FDA do not comment on personnel matters." The decision to remove Hoeg from her acting role, while described by sources as expected, had not been finalized when the reporting was completed. Hoeg was not immediately available to comment.

If her exit happens, it would occur amid what sources describe as a wider shake-up within the health department. The White House has increased its oversight of the department in recent months as public opinion polling has highlighted the political sensitivity of Secretary Kennedy's efforts to alter federal vaccine policy. Those polls suggest such revisions could carry political costs in November's midterm elections, which will determine whether Republicans maintain control of Congress.

The developments touch on internal leadership at a major regulatory agency and on contentious vaccine policy changes that have prompted legal action. The pause in implementing the childhood schedule revision means the policy remains unsettled while the lawsuit proceeds.

Contact: Not available for immediate comment from the acting director; HHS spokeswoman provided the departmental statement.

Risks

  • Personnel instability at HHS and FDA could slow regulatory decision-making and oversight - relevant to healthcare, pharmaceuticals, and biotech sectors.
  • The paused childhood vaccination schedule and pending litigation introduce policy uncertainty for public health programs and vaccine manufacturers - relevant to vaccine producers and public health funding.
  • Increased political scrutiny and White House involvement tied to polling on vaccine policy could create shifting priorities ahead of the November midterm elections - relevant to government health agencies and stakeholders engaged with federal policy.

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