FDA’s top vaccine and gene therapy official resigns

Dr. Vinay Prasad, Director of the Food and Drug Administration’s Center for Biologics Evaluation and Research, resigned on 29 July 2025 following a high-profile public campaign against him, led by right-wing influencer Laura Loomer, reports the New York Times. Prasad, known for his skepticism toward rapid drug approvals, had recently denied several treatments for rare diseases, drawing the ire of both political actors and patient advocacy groups.

During his tenure, Prasad limited use of COVID-19 vaccines and increased warnings on potential cardiac side effects. His critics accused him of politicizing drug reviews, noting his history of progressive activism and anti-Trump statements. Loomer and former Senator Rick Santorum, with ties to affected biotech firms, amplified attacks, questioning Prasad’s impartiality and alleging deliberate obstruction of the administration’s deregulatory priorities.

Despite support from senior health officials—including HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary—political backlash won the day. Advocacy organizations for rare disease patients strongly objected to drug access restrictions and regulatory delays, intensifying scrutiny. Industry stakeholders raised concerns that Prasad’s rigorous evidentiary standards—favoring robust clinical trials—undermined the Right to Try law and delayed innovations.