The U.S. Food and Drug Administration has appointed Katherine Szarama as the acting director of its Center for Biologics Evaluation and Research, the agency confirmed on Thursday. Szarama will lead the unit that handles regulation of vaccines, gene therapies and the blood supply after the recent departure of Vinay Prasad.
Prasad's term at the center ended this week. He is an oncologist who, prior to joining the agency, had been publicly critical of U.S. drug and vaccine policy, notably on COVID-19 mandates. During his time at the FDA, his tenure was notable for several high-profile decisions involving rare disease drugs and vaccines.
FDA Commissioner Marty Makary said earlier this week that a permanent successor to Prasad has not been selected. Makary indicated that the agency expects to announce a permanent appointment in the coming weeks, leaving the center under interim leadership in the near term.
Szarama's assumption of the acting director post places her at the helm of a center with wide-ranging responsibilities in public health and biomedical regulation. The Center for Biologics Evaluation and Research is charged with reviewing and approving vaccines, overseeing gene therapy products, and managing policies related to the national blood supply.
The leadership change follows a period during which the center made decisions drawing public attention. Prasad's background as an oncologist and his prior public positions on drug and vaccine policies were frequently referenced during his time at the agency. His exit and the ongoing search for a permanent director create a brief interval of transition for the center's management team.
Commissioner Makary's statement that a permanent successor is still to be named frames the next several weeks as a period of selection and potential clarification of the center's longer-term leadership. Until a permanent director is announced, Szarama will carry out the center's duties in an acting capacity.
Clear summary
Katherine Szarama has been appointed acting director of the FDA's Center for Biologics Evaluation and Research following Vinay Prasad's departure. The center regulates vaccines, gene therapies and the blood supply. No permanent replacement has been named, and the agency expects to make an announcement in the coming weeks.
Key points
- The FDA has installed Katherine Szarama as acting director of the Center for Biologics Evaluation and Research.
- The center is responsible for oversight of vaccines, gene therapies and the blood supply, affecting the biotech and pharmaceutical sectors as well as public health administration.
- Vinay Prasad departed this week; the agency has not yet named a permanent successor and expects to announce one in the coming weeks.
Risks and uncertainties
- No permanent director has yet been chosen - the timing and identity of a successor remain uncertain, which leaves the center in an interim leadership phase.
- Leadership change follows the departure of a director whose tenure included several high-profile decisions, leaving questions about continuity in regulatory priorities during the transition period.