Overview
- HHS and Commissioner Marty Makary confirmed Prasad’s late‑April departure with a planned return to UCSF, and Makary said a successor will be named before he leaves.
- His unit initially refused to review Moderna’s mRNA flu vaccine application in February before the FDA reversed course and accepted a revised filing.
- The agency’s standoff with UniQure over a Huntington’s gene therapy escalated to a rare press call where officials criticized the data, and a congressman later accused a senior FDA official of improper disclosure during that briefing.
- Under Prasad, CBER increased scrutiny of cell and gene therapies, rejecting or seeking new trials for multiple rare‑disease products as companies and patient groups questioned shifting standards.
- His tenure drew internal and external backlash, including a November memo alleging COVID‑vaccine‑linked child deaths condemned by 12 former FDA commissioners, while biotech shares such as UniQure rose sharply after the exit news.