Prasad Resumes Work at CBER Following 10-Day Break in California
Vinay Prasad, the hematologist-oncologist and director of the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA), has resumed his role at the agency following a brief absence. The decision for Prasad to return was made at the request of FDA Commissioner Marty Makary.
Prasad's departure from the FDA occurred on July 29, though the reasons are unclear. The departure was close in time to Sarepta Therapeutics' issues with their gene therapy for Duchenne muscular dystrophy, Elevidys. However, it is important to note that the FDA spokesperson stated that Prasad did not want to be a distraction to the FDA’s work.
The return of Prasad came after a White House review of the criticism he faced, which was primarily due to external pressure from conservative personalities, including Laura Loomer, who accused Prasad of being a "progressive leftist saboteur" working against President Donald Trump’s agenda within the FDA.
Makary has encouraged Prasad to reconsider returning to his role at the FDA, emphasizing the importance of his leadership in the agency’s critical oversight of vaccines, gene therapies, and biologics. Health and Human Services spokesman Andrew Nixon confirmed Prasad’s return to STAT News.
Steven Grossman, a policy and regulatory consultant, expressed guarded optimism about Prasad’s return, acknowledging the challenges facing the FDA in the oversight of advanced therapies, particularly due to safety issues with Sarepta’s products.
During Prasad's tenure, the FDA faced heightened scrutiny on its regulation of advanced therapies, including deaths linked to the approved Duchenne's therapy that led to a halt and then resumption of shipments under FDA oversight. Two teenage patients died after shipments of Elevidys were halted, and a third death occurred in a trial for the company's investigational limb-girdle muscular dystrophy gene therapy.
It is unclear at this time whether Prasad will also resume his role as the FDA's chief medical and scientific officer. Makary has stated that it is untrue that Prasad was pushed out of his role, and that he had resigned.
The HHS spokesperson has stated that neither the White House nor HHS will allow the media to distract from the critical work the FDA is carrying out under the Trump administration. BioSpace has reached out for further information on this matter.
[1] BioSpace. (2025, August 14). FDA Commissioner Marty Makary requests return of Vinay Prasad as CBER director. Retrieved from https://www.biospace.com/article/fda-commissioner-marty-makary-requests-return-of-vinay-prasad-as-cber-director/
[2] Endpoints. (2025, August 14). FDA Commissioner Marty Makary requests return of Vinay Prasad as CBER director. Retrieved from https://endpts.com/fda-commissioner-marty-makary-requests-return-of-vinay-prasad-as-cber-director/
[3] STAT News. (2025, August 14). FDA Commissioner Marty Makary requests return of Vinay Prasad as CBER director. Retrieved from https://www.statnews.com/2025/08/14/fda-commissioner-marty-makary-requests-return-of-vinay-prasad-as-cber-director/
[4] The New York Times. (2025, August 14). FDA Commissioner Marty Makary requests return of Vinay Prasad as CBER director. Retrieved from https://www.nytimes.com/2025/08/14/health/fda-commissioner-marty-makary-requests-return-of-vinay-prasad-as-cber-director.html
- The request for Vinay Prasad's return as the CBER director at the FDA by Commissioner Marty Makary is a significant development in the realm of policy-and-legislation, as it follows the controversy surrounding Prasad's departure and the scrutiny on the agency's regulation of advanced therapies.
- The politics surrounding Prasad's return to the FDA, marked by external pressure from conservative personalities, is a critical general-news topic, as it sheds light on the role of personalities in shaping government decisions, particularly in the context of the FDA's work in vaccine, gene therapy, and biologics oversight.
