Vinay Prasad Resigns from FDA Following Recent Controversies

Vinay Prasad, MD, MPH, has stepped down as director of the FDA’s Center for Biologic Evaluation and Research (CBER), less than 3 months after he was appointed in May 2025 by FDA Commissioner Martin Makary, MD, MPH. Dr. Prasad, a hematologist-oncologist, was also named as the agency’s chief medical and scientific officer in June.

Anonymous sources told The Associated Press that his departure was driven by several recent controversies.¹ Dr. Prasad faced backlash from right-wing journalist and activist Laura Loomer, who described Dr. Prasad as a “progressive leftist saboteur undermining President Trump’s FDA” in a July 20 article.² Loomer wrote that Dr. Prasad’s policy views—including his support for single-payer healthcare—oppose the beliefs and priorities of the Trump Administration, and urged for his removal from the FDA.²

“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 and spend more time with his family,” a spokesperson from the Department of Health and Human Services said in a statement to STAT News.³ “We thank him for his service and the many important reforms he was able to achieve in his time at FDA.”

Dr. Prasad also faced controversy in regard to safety concerns around Sarepta Therapeutics’ gene therapy for Duchenne muscular dystrophy.¹ On July 25, the FDA requested and received voluntary suspension of distribution of the gene therapy after the death of an 8-year-old boy. A subsequent investigation determined that the death was unrelated to the gene therapy.^4,5

In his role as CBER director, Dr. Prasad oversaw the “FDA’s work regulating biological products for human use under federal laws,” according to the agency’s website. The CBER is responsible for ensuring that biological products are safe, effective, and available to patients, while informing the public about their safe and appropriate use.⁶

Before his FDA appointment, Dr. Prasad served as professor in the Department of Epidemiology and Biostatistics at the University of California at San Francisco (UCSF). He completed a fellowship in cancer prevention at the National Cancer Institute and a fellowship in oncology at the National Institutes of Health. His research has focused on medical evidence, clinical decision-making, health policy, and cancer drug pricing, according to his faculty profile at UCSF.⁷

“He did a tremendous amount of implementation of new policies in the time he was at the FDA,” Dr. Makary told CNBC in response to Dr. Prasad’s departure.⁸ “I think the guy’s a genius. He’s published 550 peer-reviewed studies in his career…he gave us some of his time. He’s got family in California; the commute was brutal. When he saw some of these smear pieces, he didn’t want to be a distraction.”

Dr. Prasad also raised criticism during the COVID-19 pandemic for his alleged “anti-vax” views, a label he denied during an FDA Direct conversation with Dr. Makary,⁹ Blood Cancers Today previously reported. Rather, he considers whether clinical evidence supports vaccination and described himself as “a longstanding believer in evidence-based medicine” during a CBER Town Hall meeting on May 20, where he outlined the FDA’s evidence-based strategy for COVID vaccination.¹⁰

Dr. Prasad announced that based on prior immunologic end points, the FDA will consider approval for patients 65 and older and for those with severe risk of COVID-19. In addition, the FDA asks companies to conduct a randomized trial testing their product against a placebo in patients aged 50 to 64.¹⁰

“These data are vital to inform an updated risk-benefit analysis that’s fit for 2025,” he said during the meeting.¹⁰

Drs. Prasad and Makary have not responded to Blood Cancers Today’s request for comment.