Vinay Prasad, the US Food and Drug Administration's (FDA) head of vaccines and gene therapy, will leave his position at the end of April 2026[1][2]. Prasad was coming to the FDA with the goal of implementing four major reforms, including changing clinical trial requirements, establishing a national priority review system, and a new framework for ultra-rare diseases[1]. During his tenure, he faced criticism from the rare disease patient community, notably over the rejection of several drugs, including uniQure's gene therapy for Huntington's disease[1]. Prasad previously left the FDA unexpectedly in July 2025 amid controversy surrounding gene therapy decisions, but returned shortly thereafter[2]. FDA Commissioner Marty Makary announced that the agency would select Prasad's successor before his departure[1]. Prasad returns to the University of California, San Francisco, where he was initially on leave for a year[2].