Government official Prasad returns to the Center for Biologics Evaluation and Research (CBER) following a 10-day break spent in California.

Government official Prasad returns to the Center for Biologics Evaluation and Research (CBER) following a 10-day break spent in California.

In a surprising turn of events, Vinay Prasad has returned as the Director of the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA) just 12 days after his initial departure. FDA Commissioner Marty Makary personally requested Prasad's reinstatement following a White House review that countered the criticisms that had contributed to Prasad's initial resignation.

Prasad's departure was closely followed by a rollercoaster month for Sarepta Therapeutics, a biotech company whose Duchenne muscular dystrophy gene therapy faced safety concerns. Three deaths of patients were reported in relation to Sarepta Therapeutics' gene therapy and a trial for the company's investigational limb-girdle muscular dystrophy gene therapy.

Prasad's management of these gene therapy safety concerns, particularly those related to Sarepta Therapeutics, and his past political support of Democrats, were subjects of criticism by right-wing influencer Laura Loomer. Despite this, Commissioner Makary, who appointed Prasad in May 2025, intervened to have him return, emphasizing the importance of Prasad’s leadership amid ongoing regulatory challenges in biologics and gene therapy.

The White House and Department of Health and Human Services supported Makary's decision, underscoring that they would not let negative media or political distractions undermine the FDA’s critical work during the current administration. Makary played a central role as the authoritative figure facilitating Prasad’s reinstatement, prioritizing continuity in overseeing key biologics regulations despite the surrounding controversies.

Heather McKenzie, a reporter for BioSpace, reached out to HHS for independent confirmation and further information on these and other details. It is unclear at this time whether Prasad will also resume his role as the FDA's chief medical and scientific officer.

Steven Grossman, policy and regulatory consultant and author of the FDA Matters blog, expressed guarded optimism about Prasad's return. The HHS spokesperson told Endpoints that neither the White House nor HHS will allow fake news media to distract from the critical work the FDA is carrying out under the Trump administration.

Prasad himself decided to return to California and spend more time with his family before being asked to return by Commissioner Makary. Makary encouraged Prasad to reconsider returning to his role at the FDA, and he stated that it was "untrue" that Prasad was pushed out of his role and that he had resigned.

The return of Vinay Prasad as the Director of the FDA's CBER comes at a critical time for the agency, as it navigates the complexities of biologics and gene therapy regulations. As Prasad resumes his role, the FDA continues its mission to ensure the safety and efficacy of these groundbreaking treatments.

[1] [https://www.statnews.com/2025/08/01/fda-commissioner-marty-makary-asks-vinay-prasad-to-return-to-his-role-at-the-fda/] [2] [https://www.endpointsnews.com/2025/07/fda-cbers-prasad-resigns-amid-controversy-over-gene-therapy-safety-concerns-and-political-attacks/] [3] [https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-marty-makary-regarding-return-vinay-prasad-fda] [4] [https://www.biospace.com/article/vinay-prasad-returns-as-fda-cbers-director-amid-controversy-over-gene-therapy-safety-concerns-and-political-attacks/]

1. Science-related discussions regarding gene therapies and their safety became a part of the political-news agenda, with controversies surrounding the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA) under the spotlight.
2. In health-and-wellness sectors, the role of general-news reporters such as Heather McKenzie from BioSpace becomes crucial in providing unbiased information and clarity amidst controversies, especially when key figures like Vinay Prasad return to their leadership positions, as was the case with the FDA's CBER.

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