Vinay Prasad to Return as FDA Regulator Amid Conservative Backlash.

Vinay Prasad, the ousted top vaccine and gene therapy regulator at the FDA, is returning to his role at the agency's request. He abruptly departed on July 29 due to a conservative backlash, but will now return despite a White House spokesperson stating that neither the White House nor HHS will allow the "fake news media" to distract from the FDA's work.

Vinay Prasad, the former top vaccine and gene therapy regulator at the FDA, has returned to his role at the agency's request. Prasad, who left the agency on July 29 due to a conservative backlash, will resume his position overseeing vaccine, gene therapy, and blood product regulation. The FDA has requested his return, and a Health and Human Services spokesperson confirmed that Prasad will resume leadership of the Center for Biologics Evaluation and Research [1].

Prasad's departure was marked by escalating tensions related to a gene therapy product for Duchenne's muscular dystrophy made by Sarepta Therapeutics and a campaign criticizing his politics, launched by right-wing influencer Laura Loomer. Despite the controversy, the FDA has asked Prasad to return, indicating that his expertise is still valuable to the agency [1].

Meanwhile, the FDA's decision to reject Replimune's lead asset, RP1, has sparked debate about the internal dynamics and decision-making processes at the agency. The rejection was attributed to the intervention of Richard Pazdur, the director of the FDA’s Oncology Center of Excellence, during the late stages of the review process. The decision has significant implications for Replimune and other biotech companies developing cancer therapies [2].

Investors and financial professionals are closely monitoring the situation. The FDA's decision could impact Replimune's financial outlook and investor sentiment. However, some analysts suggest that Prasad's return might lead to a potential reversal of the FDA's decision, given his known hard line in reviews [3].

References:
[1] https://www.statnews.com/2025/08/09/vinay-prasad-returns-to-the-fda-weeks-after-his-ouster/
[2] https://www.ainvest.com/news/fda-intervention-leads-rejection-replimune-cancer-drug-candidate-rp1-2508/
[3] https://seekingalpha.com/news/4477132-replimune-stock-down-after-report-drug-rejection