The FDA reassigned Sandra Retzky, director of the Office of Orphan Products Development, and she is no longer in that role, an administration official confirmed. The move removes a key figure responsible for orphan drug designations and programmatic support for rare‑disease developers. The reassignment introduces uncertainty for sponsors relying on the orphan designation pathway and for teams that coordinate with the office on rare‑disease development incentives. Industry groups tracking the change flagged potential impacts on ongoing designation reviews and organizational continuity. FDA officials did not elaborate on reasons or the duration of the reassignment; companies with pending submissions will monitor staffing and procedural continuity closely as the agency communicates next steps.