FDA Leadership Shakeup Continues as CDER Directorship Remains Vacant

The U.S. Food and Drug Administration (FDA) faces ongoing leadership challenges as the search for a new director of the Center for Drug Evaluation and Research (CDER) continues. This development comes in the wake of recent high-profile departures and amid broader changes at the Department of Health and Human Services (HHS).

Tidmarsh's Brief Tenure and Abrupt Exit

George Tidmarsh, who was appointed as CDER director in July, resigned on Sunday after less than four months in the role. His departure followed an FDA probe into "serious concerns about his personal conduct," resulting in his placement on administrative leave last Friday. In a surprising turn of events, Tidmarsh appeared to reconsider his resignation, telling Endpoints News, "I'm going to fight it. It's my name and credibility."

Potential Candidates and Declined Offer

As the FDA seeks to fill the crucial CDER leadership position, several candidates have emerged:

• Richard Pazdur, director of the FDA's Oncology Center of Excellence, reportedly turned down an offer to lead CDER.
• Mike Davis, CDER's Deputy Director, has expressed willingness to assume the director's duties, though a formal selection process would still be required.
• Mary Thanh Hai, currently head of the Office of New Drugs, is also under consideration for the directorship.

A meeting between Pazdur, Davis, and FDA Commissioner Marty Makary took place at HHS on November 3, though the details of their discussion remain undisclosed.

Broader Leadership Changes at HHS

The turmoil at CDER is part of a larger pattern of leadership changes within HHS under Secretary Robert F. Kennedy, Jr.:

• Peter Marks, former head of the Center for Biologics Evaluation and Research, departed his position.
• Vinay Prasad, Marks' successor, was briefly removed from his post in late July before being reinstated 10 days later.
• Susan Monarez, former director of the CDC, was fired in late August. She later testified to lawmakers that her dismissal came after refusing to pre-approve vaccine recommendations without evidence and declining to fire career officials without cause.

Kennedy has denied allegations related to Monarez's firing.

These ongoing leadership changes and controversies continue to shape the landscape of U.S. pharmaceutical regulation, with potential implications for drug evaluation and approval processes in the coming months.