商务合作
动脉网APP
可切换为仅中文
Dr. Peter Marks, Director of the Center for Biologics Evaluation and Research within the Food and Drug Administration answers a question during a Senate Health, Education, Labor and Pensions Committee hearing to discuss the on-going federal response to COVID-19, at the U.S. Capitol in Washington, D.C., May 11, 2021..
美国食品药品监督管理局生物制品评估与研究中心主任彼得·马克斯博士于2021年5月11日在华盛顿特区美国国会大厦举行的参议院卫生、教育、劳工和养老金委员会听证会上回答了一个问题,该听证会旨在讨论联邦政府对新冠疫情的持续应对。
Greg Nash | Pool | Reuters
格雷格·纳什 | 池 | 路透社
The Food and Drug Administration's top vaccine regulator Peter Marks has resigned, citing Sec. Robert F. Kennedy Jr.'s 'misinformation and lies' around immunization, according to a resignation letter obtained by CNBC.
根据CNBC获得的一封辞职信,食品和药物管理局的顶级疫苗监管官员彼得·马克斯辞职,他在信中提到卫生部长罗伯特·F·肯尼迪(小)在免疫接种问题上“传播错误信息和谎言”。
For nearly 10 years, Marks led the FDA's Center for Biologics Evaluation and Research, a post that included evaluating Covid-19 vaccines and establishing guidelines for emerging treatments like cell and gene therapies. A key figure at the FDA, biopharma industry insiders were closely watching Marks amid the transition..
近十年来,马克斯一直领导着FDA的生物制品评估与研究中心,该职位包括评估新冠疫苗和为细胞和基因疗法等新兴治疗制定指导方针。作为FDA的关键人物,生物制药行业的内部人士在这一过渡期间一直在密切关注马克斯。
The Wall Street Journal
《华尔街日报》
first reported
首次报道
Marks's resignation, saying an official of the Department of Health and Human Services gave Marks the chance to resign or be fired. Marks, the FDA, and the Department of Health and Human Services did not immediately respond to a request for comment.
马克斯辞职,称卫生与公众服务部的一名官员给了马克斯辞职或被解雇的选择。马克斯、FDA 和卫生与公众服务部没有立即回应置评请求。
In his resignation letter, addressed to acting FDA Commissioner Sara Brenner, Marks praised the agency's staff's work to expedite the development of vaccines that met the standards for quality, safety, effectiveness expected by Americans and 'undoubtedly markedly reduced morbidity and mortality from COVID-19 in the United States and elsewhere.' He called efforts being advanced on the adverse health effects of immunization 'concerning,' specifically citing the current measles outbreak as an example of the 'clear danger' of 'undermining confidence in well-established vaccines.'.
在给代理FDA局长萨拉·布伦纳的辞职信中,马克斯赞扬了该机构工作人员加快开发符合美国人期望的质量、安全性和有效性标准的疫苗,并“无疑显著降低了美国及其他地区的新冠发病率和死亡率”。他称目前有关免疫接种不良健康影响的努力“令人担忧”,并特别引用当前的麻疹疫情作为“破坏对成熟疫苗信心”的“明显危险”的例子。
'As you are aware, I was willing to work to address the Secretary's concerns regarding vaccine safety and transparency by hearing from the public and implementing a variety of different public meetings and engagements with the National Academy of Sciences, Engineering, and Medicine,' Marks wrote. 'However, it has become clear that truth and transparency are not desired by the Secretary, but rather he wishes subservient confirmation of his misinformation and lies.'.
“正如你所知,我愿意通过听取公众意见,并与美国国家科学院、工程院和医学院举办各种不同的公开会议和互动活动,来解决秘书长对疫苗安全性和透明度的担忧,”马克斯写道。“然而,很明显,秘书长并不想要真相和透明度,而是希望得到对他误导信息和谎言的顺从确认。”
Marks was well-known among the biopharma industry, regularly speaking at conferences about finding ways to accelerate the development of innovative therapies, particularly for rare diseases. His departure could further shake a biotech industry that's been beaten down over the past few years.
马克斯在生物制药行业非常有名,他经常在会议上发表演讲,探讨加速创新疗法开发的途径,特别是针对罕见病的疗法。他的离职可能会进一步动摇过去几年一直低迷的生物技术行业。
Last fall, speaking remotely at the Jefferies London Healthcare Conference, Marks said he planned to stay as long as he was welcome.
去年秋天,马克斯在杰富瑞伦敦医疗保健会议上远程发言时表示,他计划只要受到欢迎就会继续留任。
'I will stay around as long as I'm considered to be welcome to stay around,' Marks said at the time, according to
“只要被认为受欢迎,我会继续留在这里,”马克斯当时表示,
Endpoints News
终点新闻
. 'I think it's very important that people see that there's constant leadership here — that we are here to work with either side of the aisle.'
“我认为让人们看到这里有着持续的领导力是非常重要的——我们在这里与任何一方合作。”