Vaccines and Gene Therapies

FDA Commissioner Marty Makary told staff late Friday that Dr. Vinay Prasad, the agency’s embattled head of vaccines and biotech products, will leave at the end of April 2026 to return to the University of California, San Francisco—his second departure from the post in under a year. Prasad, a longtime critic of what he called lax FDA drug standards, has recently drawn heavy fire from pharmaceutical executives, investors, some members of Congress and patient groups over a series of contentious calls, including initially refusing to let the FDA even review Moderna’s mRNA flu vaccine before abruptly reversing course and demanding an additional study. In another flashpoint, the FDA—under his purview—insisted that UniQure run a new, sham‑surgery‑controlled trial of a Huntington’s disease gene therapy it had previously guided differently, prompting an unusually public war of words in which an anonymous senior FDA official described the existing data as “stone cold negative” and the product as a “failed” therapy. Those fights cap a broader pattern in which more than half a dozen rare‑disease and specialty drugmakers say they’ve seen prior green lights walked back or been ordered to launch costly, years‑long studies, deepening industry concern about unpredictability in U.S. approval standards even as some critics of accelerated approvals quietly cheer tougher scrutiny.