CBER Director Karim Mikhail Aims to Restore Stability After Turbulent Leadership Changes

The FDA's Center for Biologics Evaluation and Research (CBER) is working to regain stability after a period of rapid leadership turnover. Karim Mikhail, who was confirmed as the permanent director last month, said his priority is to steady the center and refocus on its core mission of overseeing vaccines, gene therapies and other biologics.

The turmoil began in April 2025 when longtime director Peter Marks was removed following a clash with the HHS secretary over vaccine policy. He was succeeded by Vinay Prasad, whose brief tenure was marked by controversy, including a high‑profile dispute over Sarepta Therapeutics’ Duchenne muscular dystrophy gene therapy Elevidys. Prasad left the agency in April 2026 after an 11‑month stint.

A short‑lived interim appointment of Katherine Szarama followed, adding to the perception of a revolving‑door at the agency. Mikhail initially stepped in as acting director in May and was later confirmed, bringing a background in regulatory science and a promise of continuity.

Mikhail’s strategy emphasizes rebuilding internal confidence, improving communication with industry stakeholders, and ensuring consistent regulatory review processes. If successful, the move could reassure biotech companies and investors that CBER will provide a predictable environment for product approvals.