Fortune | FORTUNE 14小时前
Ousted vaccine regulator Vinay Prasad to return to FDA
index_new5.html
../../../zaker_core/zaker_tpl_static/wap/tpl_guoji1.html

 

美国食品药品监督管理局(FDA)曾被撤职的疫苗和基因疗法监管负责人Vinay Prasad,在卫生与公众服务部(HHS)的声明中确认将重返其岗位。HHS发言人表示,此举是应FDA的请求,旨在不受“假新闻媒体”干扰,继续推进FDA在特朗普政府下的关键工作。Prasad将重新领导生物制品评价与研究中心(CBER)。此前,他因处理Sarepta Therapeutics基因疗法的安全问题以及对新冠疫苗的立场引发争议,并在保守派的反对声浪中于7月底突然离职。尽管任职时间不长,Prasad已因要求更多新冠疫苗研究、推翻内部审查意见以及采取对抗性沟通方式而备受批评,这些都为批评者提供了攻击其可能阻碍科学创新的素材。他与FDA局长Makary曾要求Sarepta暂停一种用于治疗杜氏肌营养不良症的基因疗法,因其与三例死亡事件有关,此举曾引起轩然大波。Prasad的离职曾导致生物技术公司股价上涨,而其回归的消息也引发了新的关注。

✅ Vinay Prasad,美国FDA曾负责疫苗和基因疗法的最高监管官员,在被撤职后,将根据卫生与公众服务部(HHS)的声明,应FDA请求重返其领导生物制品评价与研究中心(CBER)的岗位。HHS方面表示,此举是为了不受外界干扰,继续推进FDA的工作。

⚠️ Prasad的重返引发了对其过往工作表现的关注。他在任职期间曾要求对新冠疫苗进行更多研究,并推翻了部分科学审查意见,其对抗性的沟通方式被批评可能阻碍科学创新。此前,他因处理Sarepta Therapeutics基因疗法安全问题引发了保守派的反对,并最终导致其离职。

📉 Prasad曾因处理Sarepta公司用于治疗杜氏肌营养不良症的基因疗法(Elevidys)而引发争议。他和FDA局长Marty Makary曾要求Sarepta暂停该疗法的运输,因为有三例死亡事件被认为与该公司的基因疗法有关。此事件导致了广泛的批评,认为FDA越权。

🚀 Prasad的离职曾引起市场反应,导致生物技术公司股价上涨。此次他重返FDA的消息,尤其是在其任职期间曾引发的争议背景下,预示着相关监管和行业动态将继续受到密切关注。

🗣️ 尽管Prasad的回归是应FDA要求,但此前包括唐纳德·特朗普的盟友Laura Loomer在内的部分人士曾表示他与总统议程不符,并积极游说反对其回归。FDA局长Marty Makary曾试图说服Prasad返回该机构。

Vinay Prasad, who was recently ousted as the top vaccine and gene therapy regulator at the US Food and Drug Administration, is returning to his role, the Department of Health and Human Services said Saturday. 

Prasad is returning at the FDA’s request, HHS spokesperson Andrew Nixon said in a written statement. “Neither the White House nor HHS will allow the fake news media to distract from the critical work the FDA is carrying out under the Trump administration,” Nixon said. 

Prasad will resume leadership of the Center for Biologics Evaluation and Research, Nixon said. It’s unclear whether he will also retake two other roles he held at the agency as chief science officer and chief medical officer. 

Prasad abruptly departed the agency on July 29 after a conservative backlash in part over his handling of safety issues with Sarepta Therapeutics Inc.’s gene therapy. Laura Loomer, an ally of Donald Trump, had said he was not aligned with the president’s agenda and has aggressively lobbied against his return. 

FDA Commissioner Marty Makary told reporters on Monday that he was trying to persuade Prasad to return to the agency.

Though Prasad was in his role for less than three months before his ouster, he managed to stir controversy at the agency. He demanded more studies of Covid vaccines, overruled his own scientific review staff and took a confrontational approach that gave critics fodder to claim he could stymie scientific innovation. 

Prasad and Makary asked Sarepta last month to stop shipping Sarepta’s treatment for Duchenne muscular dystrophy, Elevidys, following three deaths that were linked to the company’s gene therapies. Sarepta initially refused, then relented, leading to an outcry that the agency had overstepped.

Shares in biotech firms soared on news of Prasad’s departure from the agency. His return was reported earlier by Endpoints News. 

Introducing the 2025 Fortune Global 500

, the definitive ranking of the biggest companies in the world.

Explore this year's list.

Fish AI Reader

Fish AI Reader

AI辅助创作,多种专业模板,深度分析,高质量内容生成。从观点提取到深度思考,FishAI为您提供全方位的创作支持。新版本引入自定义参数,让您的创作更加个性化和精准。

FishAI

FishAI

鱼阅,AI 时代的下一个智能信息助手,助你摆脱信息焦虑

联系邮箱 441953276@qq.com

相关标签

Vinay Prasad FDA 基因疗法 疫苗监管 Sarepta Therapeutics
相关文章