FDA Reinstates Vinay Prasad as CBER Director Amidst Political Attacks and Elevidys Controversy

WASHINGTON, D.C. – Dr. Vinay Prasad has been reinstated as Director of the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA), according to an announcement from the Department of Health and Human Services (HHS) on August 9, 2025. His return follows a brief departure from the role in late July, which was linked to public criticism and controversial decisions regarding Sarepta Therapeutics’ gene therapy, Elevidys.

The reinstatement, requested by FDA Commissioner Dr. Marty Makary and supported by HHS Secretary Robert F. Kennedy Jr., signals the agency's commitment to scientific integrity despite external pressures. Dr. Prasad's initial departure came amidst what were described as "politically motivated attacks," notably from activist Laura Loomer, whose claims against Prasad have been widely debunked by scientific and legal experts.

A central point of contention was Prasad's decision to temporarily pause shipments of Sarepta Therapeutics’ Elevidys, a gene therapy for Duchenne muscular dystrophy. This action, which followed reports of patient deaths and serious adverse reactions, was taken to prioritize patient safety. The tweet clarified, > "His decision followed standard FDA procedure, prioritizing safety over commercial or political pressures." The pause has since been lifted for a subset of ambulatory Elevidys patients.

The tweet addressed several "myths" propagated against Dr. Prasad, including a "Trump voodoo doll" story and false assertions about his regulatory decisions violating the "Right to Try" law. It clarified that Elevidys is an approved drug, thus outside the scope of the "Right to Try" act, which applies to experimental drugs. Furthermore, it noted that Prasad had previously called for Dr. Anthony Fauci to step down in 2021, challenging the narrative that he admired Fauci.

Dr. Prasad, a respected hematologist-oncologist and epidemiologist, is known for his dedication to evidence-based medicine. His decisions, though sometimes met with industry pushback, are grounded in scientific evidence, a quality stakeholders deem essential for public trust. His return is seen as a strong statement that the FDA will defend science-driven leadership, even when faced with partisan attacks.