Reinstated Vaccine Authority Vinay Prasad Resumes Role at the Food and Drug Administration
Dr. Vinay Prasad Returns to Lead FDA's Center for Biologics Evaluation and Research
Dr. Vinay Prasad, a prominent figure in the medical field, has returned to his role as Director of the Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER). This centre oversees the regulation of vaccines, gene therapies, and blood products, making Prasad the FDA's chief medical and scientific officer.
Prasad's tenure, which began in late July 2025, was marked by controversy. His resignation on July 30th came under pressure from conservative critics, particularly right-wing activist Laura Loomer, who criticised his liberal/progressive stance and disagreements over the FDA's review of Sarepta Therapeutics’ gene therapy Elevidys for Duchenne Muscular Dystrophy (DMD). Loomer branded him a “progressive leftist saboteur” and amplified criticism.
Prasad's regulatory approach, which included limiting COVID-19 vaccines to high-risk groups, also met resistance. However, FDA Commissioner Marty Makary and HHS Secretary Robert F. Kennedy Jr. opposed his ouster and backed his reinstatement. After review, the White House allowed Prasad to return to CBER leadership around August 12, 2025.
Despite returning, criticism from Loomer and others continued, contributing to low FDA staff morale. Analysts suggest Prasad’s approach was disruptive in some respects, but his removal exacerbated institutional instability and politicization within the FDA’s scientific and regulatory functions.
The news of Prasad's return was announced by the Department of Health and Human Services on Saturday. It's unclear whether Prasad will also retake his roles as chief science officer and chief medical officer. Laura Loomer, an ally of Donald Trump, has aggressively lobbied against Prasad's return.
The return of Prasad to the FDA was not without controversy. Prasad and Makary asked Sarepta last month to stop shipping Elevidys, a treatment for DMD. The agency's decision to request Sarepta to stop shipping Elevidys caused an outcry that the FDA had overstepped. Sarepta initially refused to stop shipping Elevidys, but later relented.
The outcry over Prasad's handling of safety issues with Sarepta Therapeutics Inc.'s gene therapy is ongoing. The White House and HHS have stated that they will not allow media distractions to affect the critical work the FDA is carrying out under the Trump administration.
In a statement, the FDA said, "Dr. Prasad's return to the FDA is at the agency's request. We are confident that his leadership will continue to uphold the FDA's commitment to public health and safety."
As Prasad resumes leadership of the CBER, the FDA faces challenges in maintaining its scientific integrity amidst political pressures. The clash between scientific regulatory decisions and political pressures is a complex issue that the FDA must navigate carefully to ensure the safety and efficacy of the products it regulates.
- Prasad's return to the helm of the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA) has reignited discussions about the intersection of science, health, and politics, particularly with regards to medical-conditions like Duchenne Muscular Dystrophy (DMD).
- In the realm of health-and-wellness and science, Prasad's leadership style has been polarizing, with critics ragingly debating his decisions on issues such as COVID-19 vaccine distribution and the regulation of gene therapies like Elevidys for DMD.
- The resurgence of Prasad's role in the FDA comes amidst a backdrop of ongoing scrutiny of food and drug safety, amplified by political rhetoric and news surrounding the approval processes for medical-conditions treatments.
