Clash Over FDA’s Top Lawyer Appointees Causes Further Discord Between Agency ...

在FDA的高级律师任命问题上的冲突导致了机构之间的进一步不和。

2021-01-13 07:31:26 BioSpace

本文共1089个字,阅读需3分钟

Pete Marovich/Getty Images The U.S. Food and Drug Administration (FDA) is experiencing abrupt and noticeable personnel changes as it continues to clash with the Health and Human Services (HHS), the department that oversees the agency and its operations. As reported in POLITCO, the FDA on Monday went through three different top lawyer nominees after the agency’s top lawyer resigned prior to the inauguration of President-elect Joe Biden. Stacy Cline Amin stepped down as chief counsel, with the FDA announcing Mark Raza as the acting replacement for the position. But HHS had other ideas, instead announcing in a tweet on Monday that James Lawrence would serve as the chief counsel. Lawrence moved into the department’s legal team in May of last year. According to two officials, White House Chief of Staff Mark Meadows supported the decision to appoint Lawrence as the agency’s top lawyer. In a statement made by HHS chief of staff Brian Harrison and published in POLITICO, Lawrence "has been a trusted advisor on food and drug issues and instrumental in numerous recent actions which will positively impact the FDA's public health mission.” The HHS claims the FDA made too quick of a decision on naming a career civil servant for chief counsel. Amin joined the FDA in 2018 after serving in the White House for 18 months. Amin clashed with lawyers at the HHS, and some officials have suggested the departure of Amin was planned prior to Monday’s announcement. These last-minute decisions from the HHS have reportedly annoyed health officials at the FDA. A few officials at the agency are preparing for HHS to rush in additional policy changes before President Trump leaves office, POLITCO reported on Monday. These changes in deregulatory policies, which appear to be organized by Lawrence, may “roll back” FDA’s reviews that the agency and its allies have previously opposed. "I've been disappointed to see HHS infringing on FDA's public health prerogatives in the closing days of the administration," according to a tweet made by former Trump FDA commissioner Scott Gottlieb following the announcement of the new policies. "The way they're pursuing these unilateral actions will have long term consequences at a time when FDA's stature is critical to seeing us through this crisis." Current FDA Commissioner Stephen Hahn has allegedly been dueling with HHS Secretary Alex Azar, primarily in regard to the speed at which COVID-19 vaccines have been reviewed, among other policy actions. Azar had reportedly discussed firing Trump-appointed Hahn prior to November’s presidential election. Previous reports in December 2020 noted that the White House was prepared to allegedly demand the resignation of Hahn if the FDA did not grant Emergency Use Authorization to the Pfizer and BioNTech COVID-19 vaccine. Azar was confirmed as the HHS Secretary in early 2018. In September 2020, Azar assumed final authority over rules regarding food, medical devices and new treatments, with this authority encompassing COVID-19 vaccines. Changes made to how the agency handles vaccine approvals mandated that Azar would formally sign off on each new regulation. There were some concerns that this would usher in an approved COVID-19 vaccine before it was safe to use, but Gottlieb quickly disputed this fear when he appeared in CBS’ Face the Nation. Most Read Today
皮特·马罗维奇/盖蒂图片 美国食品和药物管理局(FDA)正经历着突然而引人注目的人事变动,因为它继续与监督该机构及其运作的卫生与公众服务部(HHS)发生冲突。 据POLITCO报报道,FDA的首席律师在当选总统乔拜登就职典礼前辞职,之后FDA在周一通过了三位不同的首席律师提名。Stacy Cline Amin辞去首席法律顾问一职,FDA宣布Mark Raza代理该职位。 但HHS另有想法,而是在周一的推文中宣布詹姆斯·劳伦斯将担任首席法律顾问。劳伦斯去年5月调入司法部的法律小组。据两名官员说,白宫办公厅主任马克·梅多斯支持任命劳伦斯为该机构首席律师的决定。 在HHS办公室主任Brian Harrison发表在POLITICO上的声明中,劳伦斯“在食品和药品问题上一直是一位值得信赖的顾问,并在最近的许多行动中发挥了重要作用,这些行动将对FDA的公共卫生使命产生积极影响。 HHS声称FDA在任命一名职业公务员为首席法律顾问的问题上做得太快了。阿明在白宫任职18个月后,于2018年加入FDA。阿明在HHS与律师发生冲突,一些官员暗示阿明的离职是在周一宣布之前就计划好的。 据报道,HHS在最后一分钟做出的这些决定惹恼了FDA的卫生官员。据POLITCO周一报道,该机构的一些官员正在为HHS在特朗普总统离任前匆忙出台更多的政策改革做准备。这些看来是由劳伦斯组织的放松管制政策的变化,可能会使FDAS及其盟友此前反对的审查倒退。 新政策宣布后,特朗普前FDA专员斯科特·戈特利布在推特上写道:“我很失望看到HHS在政府的最后几天侵犯FDA的公共卫生特权。”“他们采取这些单边行动的方式将产生长期后果,因为FDA的地位对我们渡过这场危机至关重要。” 现任FDA专员Stephen Hahn据称一直在与HHS部长Alex Azar决斗,主要是关于COVID-19疫苗的审查速度,以及其他政策行动。据报道,阿扎尔曾讨论在11月总统选举前解雇特朗普任命的哈恩。此前2020年12月的报道指出,如果FDA不给予辉瑞和BioNTech公司的COVID-19疫苗紧急使用授权,白宫准备据称要求哈恩辞职。 阿扎尔在2018年初被确定为HHS秘书。2020年9月,阿扎尔接管了有关食品,医疗器械和新疗法的最终权力,这一权力包括COVID-19疫苗。该机构处理疫苗审批的方式发生了变化,要求阿扎尔正式签署每一项新规定。有些人担心,这会在COVID-19疫苗安全使用之前迎来批准的疫苗,但Gottlieb在CBSFace the Nation节目中迅速反驳了这种担心。 今天阅读最多的

以上中文文本为机器翻译,存在不同程度偏差和错误;偶尔因源网页结构局限,内容无法一次完整呈现。请理解并参考原站原文阅读。

阅读原文