The FDA reassigned the director of the office responsible for orphan drug designations, an internal realignment confirmed to industry press. The official, Sandra Retzky, was removed from the director role and reassigned within the agency, according to sources close to the matter. The reorganization follows heightened scrutiny of orphan‑drug policy and its intersection with accelerated pathways, pricing and exclusivity, and comes as companies increasingly rely on orphan designations for regulatory and commercial advantages. Biotech compliance and regulatory teams noted the leadership change could affect orphan designation processes and encouraged sponsors to engage early with the agency to clarify expectations during the transition.