The director of the FDA office that oversees orphan drug designations was removed from the role and reassigned, an administration official confirmed to Endpoints News. Sandra Retzky’s reassignment represents an internal leadership change at the Office of Orphan Products Development, the agency unit that plays a central role in granting incentives for therapies targeting rare diseases. Regulatory insiders said the shift could affect timelines and policy decisions around orphan designations and sponsor interactions, though the FDA characterized the move as an administrative reassignment. Sponsors and patient groups monitor such leadership changes closely because the office interprets policies that materially influence trial design, development incentives, and regulatory engagement for rare disease programs.