FDA Health and Human Services Katherine Szarama Vinay Prasad Center for Biologics Evaluation and Research biologics regulation vaccine approval gene therapy oversight FDA leadership rare disease drugs

The U.S. Food and Drug Administration (FDA) has appointed Katherine Szarama as the acting director of the Center for Biologics Evaluation and Research (CBER), the agency confirmed on June 13, 2025.

CBER oversees the regulation of vaccines, gene therapies, and the national blood supply, making Szarama’s appointment a key leadership change within the FDA’s biologics division.

A senior official at the U.S. Department of Health and Human Services (HHS) verified the appointment to STAT, noting that the news was first reported by Politico.

Szarama takes over from Vinay Prasad, who stepped down from his role on June 12, 2025, following a tumultuous tenure at the FDA. During his time as CBER director, Prasad made several controversial decisions, particularly regarding the approval of treatments for rare diseases and vaccines.

In March 2025, FDA Commissioner Marty Makary announced that Prasad would return to his position at the University of California, San Francisco, where he previously served as a professor.

The leadership transition at CBER comes at a critical time, as the FDA continues to navigate complex regulatory challenges in the biologics and vaccine sectors.

Source: STAT News
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