路透社报道
2026年3月6日 美国东部时间晚上10:09 更新于1小时前
节点运行失败
美国马里兰州怀特奥克的美国食品药品监督管理局总部外的标识，2020年8月29日拍摄。路透社/Andrew Kelly/资料图
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3月6日（路透社）——美国卫生与公众服务部一位发言人周五表示，美国食品药品监督管理局（FDA）疫苗和生物制品部门负责人Vinay Prasad博士将于4月底离开该机构。
Prasad是一名肿瘤学家，在加入该机构之前曾直言不讳地批评美国的药物和疫苗政策，他因多项监管决策引发争议。他领导负责批准疫苗和生物技术产品的部门，其任期内发生了一系列备受瞩目的产品审查争议。
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他于去年5月被任命为FDA生物制品评价与研究中心主任。他曾在7月短暂离职，美国卫生与公众服务部表示他不想成为干扰因素，两周多一点后他又回到了该职位。
他的任期包括涉及Sarepta Therapeutics公司（SRPT.O，新标签页打开）Duchenne型肌营养不良症基因疗法Elevidys的有争议决定。
FDA一直与荷兰制药商UniQure就其亨廷顿舞蹈症基因疗法陷入拉锯战。
美国药品监管机构要求进行一项新研究以支持批准该公司针对罕见脑部疾病的基因疗法，但该公司和患者倡导者认为，监管机构要求的研究对患者来说过于漫长和繁重。
卫生与公众服务部指责该公司就监管机构要求误导公众。
Christy Santhosh和Kamal Choudhury在班加罗尔报道；Sriraj Kalluvila和Shinjini Ganguli编辑
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（注：原文中“节点运行失败”可能是系统错误导致的异常内容，已按原样保留。）
FDA vaccines chief Vinay Prasad to step down in April
By Reuters
March 6, 2026 10:09 PM UTC Updated 1 hour ago
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Signage is seen outside of the Food and Drug Administration headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo
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March 6 (Reuters) – The head of the U.S. Food and Drug Administration’s vaccines and biologics unit, Dr. Vinay Prasad, will leave the agency at the end of April, a spokesperson for the U.S. Department of Health and Human Services said on Friday.
Prasad, an oncologist and outspoken critic of U.S. drug and vaccine policies before joining the agency, has drawn controversy over several regulatory decisions. He led the division responsible for approving vaccines and biotechnology products, and his tenure included a series of high‑profile disputes over product reviews.
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He was appointed director of the FDA’s Center for Biologics Evaluation and Research in May last year. He briefly stepped down in July, with the Department of Health and Human Services saying he did not want to be a distraction, before returning to the role a little over two weeks later.
His tenure included contentious decisions involving Sarepta Therapeutics’ [(SRPT.O), opens new tab] Duchenne muscular dystrophy gene therapy Elevidys.
The FDA has been mired in a back and forth with Dutch drugmaker UniQure over its gene therapy for Huntington’s disease.
The U.S. drug regulator called for a new study to support the approval of the company’s gene therapy for the rare brain disorder, but the company and patient advocates argued that what the study regulators were asking for was too lengthy and onerous on patients.
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HHS has accused the company of misleading the public about what regulators were asking for.
Reporting by Christy Santhosh and Kamal Choudhury in Bengaluru; Editing by Sriraj Kalluvila and Shinjini Ganguli
Our Standards: [The Thomson Reuters Trust Principles., opens new tab]
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