FDA Names Deputy Katherine Szarama Acting CBER Director as Vinay Prasad Departs

The Food and Drug Administration has named Katherine Szarama acting director of its Center for Biologics Evaluation and Research (CBER), the unit that regulates vaccines, gene therapies and the blood supply, STAT reported on April 30. A Health and Human Services official confirmed the move, which was first reported by Politico, to STAT.

Szarama replaces Vinay Prasad, who left the agency on Thursday, according to STAT. Prasad had served as both director of CBER and the FDA's chief medical and scientific officer, leading the agency's oversight of vaccines, drugs and biotherapies, and Commissioner Marty Makary confirmed in March that Prasad would resign from both positions at the end of April, AABB reported at the time. Makary said in March that Prasad would return to the University of California San Francisco, STAT reported.

Who is leading CBER

Szarama has served as Prasad's deputy since December 2025, according to her LinkedIn profile, RAPS reported. Before joining the FDA, she worked as a social science research analyst and presidential management fellow at the Centers for Medicare and Medicaid Services, as director of clinical trials at Arnold Ventures and as a program manager at the Advanced Research Projects Agency for Health (ARPA-H), according to RAPS.

It is not clear when a permanent director will be named. At a news conference on Thursday, Makary said the selection process is progressing but did not provide a timeline, RAPS reported.

A contested tenure

Prasad's time at the center was marked by several controversies, RAPS reported, including overruling reviewers to deny or delay products such as Moderna's mRNA influenza vaccine and uniQure's Huntington's disease treatment, and allegations of abusive treatment toward subordinates. STAT described his tenure as tumultuous, marked by a series of controversial decisions on rare disease drugs and vaccines.

The leadership change came during a busy week at the agency. RAPS reported that Makary also announced plans for a pilot aimed at real-time review of clinical trials by regulators, and that the House Appropriations Committee on Wednesday approved a bill that would fund the FDA for fiscal 2027 at $7.1 billion, less than the $7.2 billion requested by the Trump administration. The agency also launched two proof-of-concept studies that will gather and report endpoints and other signals from early-phase studies to regulators in real time, according to RAPS.

Rep. Rosa DeLauro of Connecticut, the committee's ranking member, opposed the funding bill, asserting that the administration “is less focused on proven treatments and more attentive to Secretary Kennedy’s personal opinions,” according to a statement from her office cited by RAPS.