2026-05-01 12:18:53 UTC / 路透社
作者：卡迈勒·乔杜里
2026年5月1日 美国东部时间下午12:18 更新于2小时前
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5月1日（路透社）——美国卫生与公众服务部一名官员周五对路透社表示，美国食品药品监督管理局已任命凯瑟琳·沙拉马为其疫苗与生物制品部门代理主任，接替本周结束动荡任期的维奈·普拉萨德。
此次任命数日前，FDA局长马蒂·马卡里曾表示，尚未就普拉萨德的永久继任者做出决定，并预计将“在未来几周内”发布公告。
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沙拉马将领导生物制品评估与研究中心（CBER），该中心负责监管疫苗、基因疗法和血液供应。
普拉萨德在任期间争议不断，包括在罕见病药物和疫苗方面的多项高关注度决策，随后离任。
该消息最初由《政客》杂志报道。
加入FDA之前，身为肿瘤学家的普拉萨德因直言不讳地批评美国药品和疫苗政策（尤其是有关新冠疫情防控 mandate）而闻名。
他在CBER的任期内多次爆发冲突，最引人注目的是FDA否决了荷兰药品开发商UniQure（UQ1.F）的亨廷顿舞蹈症基因疗法申请，打开新标签页。
美国药品监管机构呼吁开展新的研究，以支持对这种罕见脑部疾病治疗药物的审批。
然而，UniQure和患者维权人士称，这一要求耗时过长，给患者带来沉重负担，而美国卫生与公众服务部则指责该公司就监管机构的要求误导公众。
普拉萨德曾于去年7月突然辞职，称不想成为干扰因素。一周多后他便官复原职。
拥有博士学位的沙拉马于2016年至2019年期间在医疗保险和医疗补助服务中心工作，随后加入埃默森集体和阿诺德风险投资公司。她于去年12月加入FDA，担任CBER副主任，向普拉萨德汇报工作。
卡迈勒·乔杜里在班加罗尔报道；什雷亚·比斯瓦斯和马朱·塞缪尔编辑
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US FDA taps Szarama as acting head of vaccine unit
2026-05-01 12:18:53 UTC / Reuters
By Kamal Choudhury
May 1, 2026 12:18 PM UTC Updated 2 hours ago
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Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo Purchase Licensing Rights, opens new tab
May 1 (Reuters) – The U.S. Food and Drug Administration has named Katherine Szarama as the acting director of its vaccines and biologics unit, a Health and Human Services official told Reuters on Friday, replacing Vinay Prasad, whose turbulent tenure came to an end this week.
The appointment comes days after FDA Commissioner Marty Makary said no decision had been reached on Prasad’s permanent successor and that he expected an announcement “in the coming weeks.”
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Szarama will lead the Center for Biologics Evaluation and Research (CBER), which regulates vaccines, gene therapies and the blood supply.
Prasad left the agency after a term marked by controversy, including several high-profile decisions on rare disease drugs and vaccines.
The news was first reported by Politico.
Before joining the agency, Prasad, an oncologist, was known for his vocal criticism of U.S. drug and vaccine policies, especially concerning COVID-19 mandates.
His time at CBER was marked by repeated clashes, most notably the FDA’s rejection of a Huntington’s disease gene therapy from Dutch drug developer UniQure (UQ1.F), opens new tab.
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The U.S. drug regulator called for a new study to support the approval of the company’s treatment for the rare brain disorder.
However, UniQure and patient advocates said the request was too lengthy and onerous on patients, while the HHS accused the company of misleading the public about regulators’ requirements.
Prasad had previously resigned abruptly in July last year, saying he did not want to become a distraction. He was reinstated a little more than a week later.
Szarama, who holds a PhD, worked at the Centers for Medicare and Medicaid Services from 2016 to 2019, then moved to the Emerson Collective and Arnold Ventures. She joined the FDA in December as CBER deputy director, reporting to Prasad.
Reporting by Kamal Choudhury in Bengaluru; Editing by Shreya Biswas and Maju Samuel
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