Latest news with #Vinay Prasad
The Guardian
2 days ago
- Health
- The Guardian
Vinay Prasad returns to FDA days after leaving under pressure from Laura Loomer
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. 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. 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 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. 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. 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 Guardian
2 days ago
- Health
- The Guardian
Vinay Prasad returns to FDA days after leaving under pressure from Laura Loomer
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. Prasad left the agency on 30 July after just a few months as director of the center. Stat News 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. 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 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. 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. 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.
New York Times
2 days ago
- Health
- New York Times
Ousted F.D.A. Vaccine Chief Returns to Agency
Dr. Vinay Prasad, who led the Food and Drug Administration's vaccines and gene therapy division before resigning under pressure two weeks ago, is returning to the agency, a Department of Health and Human Services spokesman confirmed Saturday. Dr. Prasad left the F.D.A. in late July after being targeted by the right-wing activist Laura Loomer and others who criticized his decisions regarding certain medications and pointed out critical comments he had made about President Trump before joining the administration. A series of editorials published in the weeks leading up to Dr. Prasad's resignation also appeared to have contributed to the pressure on him. Those editorials found fault with his decisions to deny drug approvals and to demand a pause on a medication linked to several patient deaths. Dr. Prasad's return was an unusual instance of a federal official being allowed to rejoin the administration after being targeted by Ms. Loomer for being insufficiently loyal to the president. She has repeatedly demonstrated her influence over federal personnel decisions. His rehiring also suggests that the health secretary, Robert F. Kennedy Jr., and the F.D.A. commissioner, Dr. Marty Makary, remain influential enough in the Trump administration to employ someone who had previously expressed disdain for Mr. Trump and his followers. 'At the F.D.A.'s request, Dr. Vinay Prasad is resuming leadership of the Center for Biologics Evaluation and Research,' Andrew Nixon, a health department spokesman, said in a statement. In a post on X Saturday, Ms. Loomer called Dr. Prasad's return 'another egregious personnel decision,' describing him as a 'Marxist.' She also pledged to ramp up her campaign against other health officials she deemed 'rabid Trump haters.' Before the resignation, Mr. Kennedy and Dr. Makary had defended Dr. Prasad against the mounting attacks, even as those seeking to have him fired lobbied the White House directly with their concerns, people familiar with the conversations said. Dr. Makary called him an 'impeccable scientist,' and Mr. Kennedy told an associate he wanted Dr. Prasad at the F.D.A. in part because of his approach to vaccines, according to people familiar with the conversation. Dr. Prasad had played a key role in the decision in May to limit the use of the Covid vaccine to people over 65 and to those with medical conditions that put them at high risk for severe illness. Their advocacy fell short, though, and Dr. Prasad issued his resignation on July 29. Dr. Prasad's long-running penchant for sharp criticism of the federal health bureaucracy, often peppered with expletives, led to intense speculation about the reasons for his ouster. It was a surprise to many in medical circles when Dr. Makary said at an event with Mr. Kennedy earlier this week that he was seeking to bring Dr. Prasad back to the F.D.A. Before entering government, Dr. Prasad was an oncologist and epidemiologist at the University of California, San Francisco, where he was active on Substack, YouTube and other social media sites, often excoriating public health officials for their approaches to the pandemic and what he viewed as poor decisions by the F.D.A. After joining the agency, he attracted attention for declining to approve several drugs, including one meant to treat advanced skin cancer and another meant to treat heart conditions for patients with a rare muscle disorder. Dr. Prasad had long called on the F.D.A. to take a stronger stance against drugs with a high price tag and uncertain benefits for patients. He has taken a similar position on vaccines, saying they need more careful examination before authorization and heightened scrutiny after. In the weeks before his ouster, Dr. Prasad also called on the company Sarepta Therapeutics to stop shipping its gene therapy drugs after the deaths of two teenagers and a 51-year-old man were deemed related to the medication. The company initially refused but later conceded. Since then, the company has resumed shipments of the medication for younger patients.
Reuters
2 days ago
- Health
- Reuters
Vinay Prasad returns to role as top vaccine regulator at FDA days after leaving US agency
Aug 9 (Reuters) - Vinay Prasad is returning to his role overseeing vaccine, gene therapy and blood product regulation at the U.S. Food and Drug Administration 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," U.S. Health and Human Services spokesperson Andrew Nixon said in an emailed statement to Reuters. Prasad left the agency on July 30 after just a few months as director of the center. STAT News first reported the return of Prasad. Prasad, an oncologist who was a fierce critic of U.S. COVID-19 vaccine and mask mandates, was named the center's director by FDA Commissioner Marty Makary in May. Criticism of Prasad's tenure intensified around the agency's handling of a gene therapy for Duchenne muscular dystrophy from Sarepta Therapeutics (SRPT.O), opens new tab. 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 July 18 to stop all shipments of the approved DMD therapy, saying it had safety concerns. The FDA changed course on Sarepta on July 28 and said shipments to the main group of patients for the drug could restart. Laura Loomer, a far-right activist and an ally of U.S. President Donald Trump, posted a blog on July 20 in which she called Prasad a "progressive leftist saboteur" who was undermining the agency's work. 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 U.S. Health Secretary Robert F. Kennedy Jr.
Reuters
2 days ago
- Health
- Reuters
Vinay Prasad returns to US' FDA, resumes role overseeing vaccine, gene therapy, STAT News reports
Aug 9 (Reuters) - Vinay Prasad is returning to his role at the U.S. Food and Drug Administration to resume overseeing vaccine, gene therapy and blood product regulation, STAT News reported on Saturday. "At the FDA's request, Dr. Vinay Prasad is resuming leadership of the Center for Biologics Evaluation and Research," STAT News quoted Health and Human Services spokesperson Andrew Nixon as saying. Prasad left the agency in July after just three months as director of the center. Reuters could not immediately verify the report.
