Prasad Returns to Head FDA’s CBER

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Vinay Prasad is resuming his position as head of FDA’s Center for Biologics Evaluation and Research (CBER) just over a week after stepping down (1). “At the FDA's request, Dr. Vinay Prasad is resuming leadership of the Center for Biologics Evaluation and Research,” US Health and Human Services spokesperson Andrew Nixon confirmed in a statement to Reuters (2). Less than 2 weeks earlier, Nixon told Biopharma Dive that “Dr. Prasad did not want to be a distraction to the great work of the FDA in the Trump administration and has decided to return to California to be with his family” (3).

Prasad, an oncologist with prior roles at the University of California San Francisco, the National Cancer Institute, and the National Institutes of Health, was appointed to lead CBER in May by FDA Commissioner Marty Makary (3). His return comes after a short departure that began as abruptly on July 30.

Gene Therapy Safety and Regulatory Pressures

Prasad’s tenure has unfolded against the backdrop of heightened scrutiny over FDA’s regulation of advanced therapies, particularly gene therapies (3). Criticism intensified following the agency’s handling of Sarepta Therapeutics’ gene therapy for Duchenne muscular dystrophy (DMD). The therapy was linked to the deaths of two teens with advanced DMD. After a third death in a separate experimental therapy from the same company, FDA on July 18 halted shipments of the approved product due to safety concerns (3).

Ten days later, on July 28, the FDA revised its stance, allowing shipments to resume for the primary patient population (3). For pharmaceutical technology professionals, the rapid policy shifts underscore the challenges regulators face in balancing innovation with patient safety, especially for high-risk biologics and gene therapies.

Political Climate and Leadership Changes

Prasad’s leadership has drawn attention both inside and outside the agency. On July 20, activist Laura Loomer criticized him publicly, calling him a “progressive leftist saboteur” in a blog post (2). His return also takes place amid broader leadership transitions across the FDA and other US health agencies under Health Secretary Robert F. Kennedy Jr (4-6).

For those in drug development and manufacturing, the reinstatement signals continuity at a time when the biologics sector is under intense scientific, regulatory, and political pressure. The events surrounding Sarepta’s therapy highlight FDA’s role in managing cutting-edge treatments that promise significant benefits but also carry serious risks, decisions that can directly influence development timelines, manufacturing scale-up, and market access strategies.

References

1. Bayer, M. Prasad Returns to FDA, Resuming Head of CBER Role. EndpointsNews.com. August 9, 2025.
2. Reuters. Vinay Prasad Returns to Role as Top Vaccine Regulator at FDA Days After Leaving US Agency. Reuters.com. August 9, 2025.
3. Cole, C. FDA Shake-Up: Vinay Prasad Exits Amid Tumult in Biologics Oversight. BioPharmInternational.com. July 30, 2025.
4. Cole, C. Implications of RFK Jr.’s CDC Vaccine Committee Overhaul for the Pharmaceutical Industry. BioPharmInternational.com. June 10, 2025.
5. Lavery, P. RFK Jr.'s Removal of Thimerosal from Flu Vaccines Spurs Opposing Reactions. BioPharmInternational.com. July 24, 2025.
6. Lavery, P. Reaction and Fallout as HHS ‘Winds Down’ mRNA Vaccine Development, Canceling $500 Million in Projects. BioPharmInternational.com. August 6, 2025.