Amid an unprecedented period of turmoil at the Food and Drug Administration, Commissioner Marty Makary has tapped yet another person to lead the powerful Center for Drug Evaluation and Research.

在食品和药物管理局经历前所未有的动荡时期之际，局长马蒂·马卡里再次任命了一位人士来领导强大的药物评估与研究中心。

The FDA on Wednesday said Tracey Beth Høeg, a sports medicine specialist and COVID vaccine skeptic, will

FDA周三表示，运动医学专家兼新冠疫苗怀疑论者特雷西·贝丝·霍格将

serve as acting director

担任代理主任

at CDER following the

在CDER之后跟随

retirement of the current head, Richard Pazdur

当前负责人Richard Pazdur退休

. Pazdur, a longtime veteran of the agency who had been hailed as a stabilizing force, stepped down just weeks after being

帕兹杜尔是该机构的一位长期资深人士，曾被誉为稳定力量，却在被批评后的数周内辞职。

tapped as director

被任命为导演

.

。

Høeg, who

霍格，他

completed her residency

完成了她的住院医师培训

in physical medicine and rehabilitation at the University of California, Davis, in 2018, joined the FDA earlier this year as a senior adviser to Makary. She had been critical of

2018年在加州大学戴维斯分校物理医学与康复专业毕业，今年早些时候加入FDA，担任马卡里的高级顾问。她曾批评过

U.S. school closures

美国学校关闭

during the COVID-19 pandemic and co-authored a paper that posited vaccine booster mandates

在 COVID-19 大流行期间，共同撰写了一篇推测疫苗加强针强制要求的论文

were harmful to young adults

对年轻人有害

.

。

At the FDA, she reportedly was

在FDA，她据报道是

working to change the labeling

努力改变标签

for COVID vaccines to say that the risks outweighed the benefits for males between the ages of 12 and 24. Her elevation to acting director of CDER comes as government officials under longtime anti-vaccine activist Health and Human Services Secretary Robert F. Kennedy Jr. are increasingly trying to limit the use of COVID inoculations..

对于新冠疫苗，称12至24岁男性接种的风险大于益处。在长期反疫苗活动家、卫生与公众服务部部长小罗伯特·F·肯尼迪领导下的政府官员正试图限制新冠疫苗的使用之际，她被提升为CDER的代理主任。

The head of the FDA division that oversees vaccines, Vinay Prasad,

监督疫苗的FDA部门负责人Vinay Prasad，

recently sent a memo to staff

最近向员工发送了一份备忘录

tying COVID vaccines to the deaths of 10 children, citing staff “attribution” and investigative work done by Høeg and others, without providing evidence to back up that assertion. He vowed stricter rules, drawing

将新冠疫苗与10名儿童的死亡联系起来，引用了霍格及其他人员的“归因”和调查工作，但没有提供证据支持这一说法。他誓言制定更严格的规定，引发争议。

condemnation

谴责

from 12 former

来自12位前任

FDA commissioners

FDA专员

nominated by presidents of both parties.

由两党总统提名。

Høeg will become the fifth person this year to lead CDER, a division that previously had been run by only a handful of experienced veterans

霍格将成为今年第五位领导CDER的人，该部门之前仅由少数经验丰富的资深人士管理。

since its inception in 1987

自 1987 年成立以来

. The last person to hold the job for several years, Patrizia Cavazzoni,

. 该职位上一任任职多年的人员，帕特里齐娅·卡瓦佐尼，

stepped down

辞职

ahead of the incoming Trump administration. The acting director that followed her,

在特朗普政府即将上台之前，接替她的代理局长，

Jacqueline Corrigan-Curry

杰奎琳·科里根-库里

, departed months later. Makary named

，数月后离开。马卡里命名

George Tidmarsh

乔治·蒂德马什

as permanent director in July but he was gone by early November amid controversy.

7月成为常任董事，但他在11月初因争议而离职。

The turnover in the division, which oversees most new drug applications and everything from over-the-counter pills to sunscreen, has left the industry reeling. “We need organizational strength and stability at the agency,” John Crowley, the head of the Biotechnology Innovation Organization trade group, .

负责大部分新药申请以及从非处方药到防晒霜等一切事务的部门人员流动，令行业震惊。 “我们需要机构拥有组织力量和稳定性，”生物技术创新组织贸易集团负责人约翰·克劳利 (John Crowley) 。

said in a statement

声明中说

after Pazdur’s retirement announcement. “It is time to right this ship.”

在帕兹杜尔宣布退休后。“是时候纠正这艘船了。”

Pazdur was a 26-year veteran of the FDA who won plaudits from the industry and Wall Street as a thoughtful leader who spearheaded key initiatives such as streamlining approvals of cancer drugs. Pazdur reportedly

帕兹杜尔是美国食品药品监督管理局（FDA）任职26年的资深人士，他作为一位深思熟虑的领导者赢得了业界和华尔街的赞誉，他带头推动了关键举措，例如简化癌症药物的审批流程。据报道，帕兹杜尔

initially turned the CDER job down

最初拒绝了CDER的工作

and later opted for a speedy exit

随后选择了快速退出

amid tensions

紧张局势中

with Makary and concerns about plans to give certain companies

与马卡里以及对给予某些公司计划的担忧

fast-pass reviews

快速通过审查

.

。

The chaos at CDER is emblematic of issues throughout the FDA under the second Trump administration. The agency has faced Kennedy’s

CDER的混乱是特朗普第二届政府期间FDA整体问题的典型代表。该机构面临着肯尼迪的

mass layoffs

大规模裁员

, the resignations of

，辞职

key officials

关键官员

and

和

reports of a toxic environment

有毒环境的报告

under Prasad. Prasad himself quit weeks after being named as head of the Center for Biologics Evaluation and Research and then

在普拉萨德手下。普拉萨德自己在被任命为生物制品评估和研究中心负责人几周后也辞职了，然后

took the job again

再次接受了这份工作

in August.

八月。

Meanwhile, there are

与此同时，存在着

indications

适应症

that Kennedy is unhappy with Makary’s leadership on vaccines and personnel matters. Kennedy met with Pazdur on Wednesday, suggesting that he is taking the employment drama at the FDA seriously,

肯尼迪对马卡里的疫苗和人事问题领导不满。肯尼迪周三与帕兹杜尔会面，表明他正在认真对待FDA的雇用风波。

Axios reported

Axios 报道

. An HHS official told Axios the meeting was set up so that Kennedy could thank Pazdur for his service.

一位卫生部官员告诉 Axios，会议的安排是为了让肯尼迪感谢帕兹杜尔的服务。