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FDA appoints Tracy Hoeg as acting director of drug evaluation center

ReutersDecember 04, 2025 at 2:20 AMFull Content
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The FDA appoints Tracy Hoeg as acting director of CDER amid leadership changes and sweeping policy shifts under new health leadership.

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The U.S. FDA has named Tracy Beth Hoeg as acting director of the Center for Drug Evaluation and Research (CDER) following the sudden retirement of Richard Pazdur. Hoeg, a senior FDA adviser and critic of certain past pandemic policies, is seen as a key figure in the agency's ongoing transformation under FDA Commissioner Marty Makary and Health Secretary Robert Kennedy Jr. Her appointment comes during a period of major regulatory changes, including a pending vote on delaying hepatitis B vaccinations for children.

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!CDC advisory panel for vaccines convenes in Atlanta

Senior Advisor for Clinical Sciences at the FDA Tracy Beth Hoeg, MD, PhD, speaks at the meeting of the members of the Advisory Committee on Immunization Practices as the U.S. Centers for Disease Control and Prevention's (CDC) advisory panel for vaccines convenes, in Atlanta, Georgia, U.S. June 25, 2025.  REUTERS/Megan Varner * Companies

* U.S. Food and Drug Administration

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Dec 3 (Reuters) - The U.S. Food and Drug Administration said on Wednesday it has appointed Tracy Beth Hoeg as acting director of the Center for Drug Evaluation and Research, after the sudden retirement of Richard Pazdur just weeks after he assumed the role.

Pazdur, the veteran oncology chief at the regulatory agency, took over the role on November 11, after George Tidmarsh resigned amid serious concerns about his personal conduct.

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The appointment of Hoeg, a COVID vaccine skeptic and close aide to FDA Commissioner Marty Makary, comes as U.S. Health Secretary Robert Kennedy Jr. makes stark changes at the agency.

"Dr. Hoeg is the right scientist to fully modernize CDER and finish the job of establishing a culture of cross-center coordination there," Makary said.

Hoeg assumes the role at a time when the U.S. health regulator has been making sweeping changes on vaccines.

A panel will vote this week on whether to delay hepatitis B shots for most American children, a move that would be the most consequential change since the health secretary began remaking vaccine policy.

CDER is the FDA's largest and most important division, which regulates over-the-counter and most prescription drugs.

Hoeg, who opposed key U.S. health policies during the COVID-19 pandemic and questioned the use of some childhood vaccines, was named a special assistant to Makary in April.

A physician and epidemiologist, Hoeg has also practiced physical and interventional spine and sports medicine before joining the FDA as senior adviser for clinical sciences in the office of the commissioner and the Center for Biologics Evaluation and Research.

Both Hoeg and Makary expressed contrarian views on U.S. COVID policies, including opposition to mask requirements for children and universal vaccine mandates for the public, while supporting vaccination in general as a key public health measure.

Reporting by Sriparna Roy and Angela Christy in Bengaluru; Editing by Sherry Jacob-Phillips

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