Tracy Beth Høeg Named FDA CDER Director | FDA Leadership Update

by Grace Chen

Tracy Høeg Named New Leader of FDA’s Drug Evaluation Center

The Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) will have a new leader, as Tracy Høeg, a key advisor to FDA Commissioner Marty Makary, steps into the role.

The appointment comes amid a period of transition for the agency, with former CDER Director Richard Pazdur recently filing for retirement at the end of the month. Høeg’s selection marks the fifth leadership change at the center this year, signaling ongoing shifts within the FDA.

CDER plays a crucial role in ensuring the medicines we rely on are both safe and effective,” Høeg stated in an official announcement. “This is an incredible opportunity to serve my fellow Americans.”

Høeg’s rise within the FDA has been closely watched, particularly given reporting from STAT Plus detailing her influence on FDA vaccine policy as a “Covid contrarian.” This background adds a layer of complexity to her new position, as she will now oversee the evaluation and approval of all new drugs entering the US market.

Pazdur’s decision to retire followed less than a month after he initially accepted the role, reportedly at the urging of Commissioner Makary. The rapid succession of leadership changes raises questions about the stability and direction of the CDER, a critical component of the nation’s healthcare infrastructure.

The agency has not yet announced a timeline for the formal transition of leadership. Further details regarding Høeg’s priorities and vision for the CDER are expected in the coming weeks.

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