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| Vinay Prasad returns to FDA days after leaving under pressure from Laura Loomer | Vinay Prasad returns to FDA days after leaving under pressure from Laura Loomer |
| (about 2 hours later) | |
| Prasad left the agency after far-right influencer released edited audio that misleadingly suggested he was anti-Trump | Prasad left the agency after far-right influencer released edited audio that misleadingly suggested he was anti-Trump |
| Vinay Prasad is returning to his role overseeing vaccine, gene therapy and blood product regulation at the US Food and Drug Administration (FDA) a little more than a week after he left the agency. | Vinay Prasad is returning to his role overseeing vaccine, gene therapy and blood product regulation at the US Food and Drug Administration (FDA) a little more than a week after he left the agency. |
| “At the FDA’s request, Dr Vinay Prasad is resuming leadership of the Center for Biologics Evaluation and Research,” Department Health and Human Services spokesperson Andrew Nixon said in a statement to Reuters. | “At the FDA’s request, Dr Vinay Prasad is resuming leadership of the Center for Biologics Evaluation and Research,” Department Health and Human Services spokesperson Andrew Nixon said in a statement to Reuters. |
| Prasad left the agency on 30 July after just a few months as director of the center. | Prasad left the agency on 30 July after just a few months as director of the center. |
| Endpoints News, which covers the biotech industry, first reported the return of Prasad. | |
| Prasad, an oncologist who was a fierce critic of US Covid-19 vaccine and mask mandates, was named the center’s director by the FDA’s commissioner, Marty Makary, in May. | Prasad, an oncologist who was a fierce critic of US Covid-19 vaccine and mask mandates, was named the center’s director by the FDA’s commissioner, Marty Makary, in May. |
| Criticism of Prasad’s tenure intensified around the agency’s handling of a gene therapy for Duchenne muscular dystrophy (DMD) from Sarepta Therapeutics. | Criticism of Prasad’s tenure intensified around the agency’s handling of a gene therapy for Duchenne muscular dystrophy (DMD) from Sarepta Therapeutics. |
| The FDA-approved therapy played a role in the death of two teens who had advanced DMD. After a third death in a separate experimental gene therapy from the company, the FDA asked Sarepta on 18 July to stop all shipments of the approved DMD therapy, saying it had safety concerns. | The FDA-approved therapy played a role in the death of two teens who had advanced DMD. After a third death in a separate experimental gene therapy from the company, the FDA asked Sarepta on 18 July to stop all shipments of the approved DMD therapy, saying it had safety concerns. |
| The FDA changed course on Sarepta on 28 July and said shipments to the main group of patients for the drug could restart. | The FDA changed course on Sarepta on 28 July and said shipments to the main group of patients for the drug could restart. |
| Laura Loomer, a far-right influencer and conspiracy theorist with outsized sway over Donald Trump, had called Prasad a “progressive leftist saboteur” who was undermining the agency’s work. | Laura Loomer, a far-right influencer and conspiracy theorist with outsized sway over Donald Trump, had called Prasad a “progressive leftist saboteur” who was undermining the agency’s work. |
| Two days before Prasad stepped down last month, Loomer had released misleadingly edited audio to suggest that that Prasad had admitted sticking pins in a Trump voodoo doll, when the full audio made it clear that he was talking about the kind of thing an imagined liberal Trump-hater would do. | Two days before Prasad stepped down last month, Loomer had released misleadingly edited audio to suggest that that Prasad had admitted sticking pins in a Trump voodoo doll, when the full audio made it clear that he was talking about the kind of thing an imagined liberal Trump-hater would do. |
| Loomer reacted to the news of Prasad’s return on Saturday by renewing her attacks on him in a social media post in which she promised to produce “exposes of officials within HHS and FDA” in the weeks ahead. “There are several Senate Confirmation hearings coming up and I have multiple oppo books ready for distribution!” she wrote. | Loomer reacted to the news of Prasad’s return on Saturday by renewing her attacks on him in a social media post in which she promised to produce “exposes of officials within HHS and FDA” in the weeks ahead. “There are several Senate Confirmation hearings coming up and I have multiple oppo books ready for distribution!” she wrote. |
| Prasad was a physician who joined the agency from the University of California, San Francisco. He has had stints at the National Cancer Institute and the National Institutes of Health. | Prasad was a physician who joined the agency from the University of California, San Francisco. He has had stints at the National Cancer Institute and the National Institutes of Health. |
| The FDA and other health agencies have seen multiple shake-ups in recent months under the leadership of health secretary Robert F Kennedy Jr. | The FDA and other health agencies have seen multiple shake-ups in recent months under the leadership of health secretary Robert F Kennedy Jr. |