2026-08-19T00:25:00.65Z / 路透社
8月18日电（路透社）——一位知情消息人士周二表示，美国总统唐纳德·特朗普已提名白宫政策顾问海蒂·奥弗顿执掌美国食品药品监督管理局，此前该局局长马蒂·马卡里辞职已过去数月。
若获参议院批准，奥弗顿将接手的FDA在过去一年中已流失超过3000名员工，其中包括部门负责人，且该机构正面临着重建行业与公共卫生团体信任的压力，外界担忧监管机构已变得过于政治化。
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白宫、FDA和奥弗顿未立即回应路透社的置评请求。
奥弗顿为医学背景，现任白宫国内政策委员会副主任，此前曾在保守派智库“美国优先政策研究所”任职。
她在新墨西哥大学获得医学学位，曾在约翰斯·霍普金斯医院接受普通外科培训，并在约翰斯·霍普金斯大学布隆伯格公共卫生学院完成临床研究培训。
上周，奥弗顿出席了白宫活动，特朗普在活动上宣布一项行政令，呼吁缩减儿童疫苗接种计划，将麻疹、腮腺炎和风疹三联疫苗拆分为三种单独疫苗，这可能需要制药开发商耗时数年才能实现。
据路透社此前报道，奥弗顿是特朗普提名FDA commissioner的三名候选人之一，另外两人分别为肿瘤学家杰弗里·瓦西尔卡和五角大楼卫生官员斯蒂芬·费拉拉。
凯尔·迪亚曼塔斯自5月起以代理局长身份掌管该机构，此前马蒂·马卡里在任职13个月后辞职，辞职原因是与白宫高层和健康顾问产生冲突，并因一系列有争议的机构决策受到审查。
马卡里因重新引入美国市场调味电子烟、流产药物审查停滞，以及与Replimune（REPL.O）、Sarepta（SRPT.O）和Moderna（MRNA.O）等制药商就救命药物和疫苗的审评公开产生分歧而受到批评。
自迪亚曼塔斯担任代理局长以来，FDA已推翻或重新开启了Regenxbio（RGNX.O）、uniQure（UQ1.F）和Replimune（REPL.O）的罕见病疗法监管路径。
该机构还推出了旨在加快药物研发的举措，将申办方与合格研究机构配对，以缩短从药物识别到首次人体研究的时间。
在马卡里离职前，FDA生物制品部门负责人维奈·普拉萨德于4月离职，其离职原因涉及疫苗试验修订和罕见病药物驳回争议。
彭博新闻最先报道了特朗普提名奥弗顿执掌FDA的消息。
华盛顿的亚斯明·阿布塔莱布、墨西哥城的卡洛斯·门德斯、班加罗尔的克里斯蒂·桑托什报道；杰奎琳·王、汤姆·霍格和索纳利·保罗编辑
Trump picks White House adviser Heidi Overton to run FDA, source says
2026-08-19T00:25:00.65Z / Reuters
Aug 18 (Reuters) – U.S. President Donald Trump has chosen White House policy aide Heidi Overton to lead the Food and Drug Administration, a source familiar with the matter said on Tuesday, months after previous chief Marty Makary quit.
If approved by the Senate, Overton will take over an FDA that has lost more than 3,000 staff, including division heads, over the past year, and is under pressure to rebuild confidence among industry and public-health groups amid concerns the regulator has become too political.
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The White House, the FDA and Overton did not immediately respond to Reuters’ requests for comment.
Overton, a doctor by training, is currently deputy director of the White House domestic policy council and has previously worked at the America First Policy Institute, a conservative think tank.
She received her medical degree from the University of New Mexico, trained in general surgery at Johns Hopkins, and pursued clinical-investigation research training at the Johns Hopkins Bloomberg School of Public Health.
Last week, Overton appeared at a White House event where Trump announced an executive order that calls for reducing the childhood vaccine schedule and splitting the measles, mumps and rubella vaccine into three separate shots, which could take drug developers years to achieve.
Overton was among three candidates, including oncologist Jeffrey Vacirca and Pentagon health official Stephen Ferrara, the administration focused on for Trump to nominate as FDA commissioner, Reuters reported earlier.
Kyle Diamantas has been running the agency as acting chief since May, when Makary resigned 13 months into the job after clashing with top White House and health advisers and drawing scrutiny for a series of controversial agency decisions.
Makary drew criticism for his handling of the reintroduction of flavored vapes into the U.S. market, a stalled abortion-pill review and public disagreements with drugmakers such as Replimune
(REPL.O), Sarepta
(SRPT.O) and Moderna
(MRNA.O) over reviews of potentially lifesaving medicines and vaccines.
Since Diamantas took over as acting chief, the FDA has reversed course or reopened regulatory paths for rare-disease therapies from Regenxbio
(RGNX.O), uniQure
(UQ1.F) and Replimune
(REPL.O).
It also launched steps aimed at speeding up drug research by pairing sponsors with qualified research institutions to shorten the time from drug identification to first-in-human studies.
Before Makary’s exit, the FDA’s biologics division chief Vinay Prasad departed in April amid controversy over vaccine trial revisions and rare-disease drug rejections.
Bloomberg News reported first that Trump picked Overton to lead the FDA.
Reporting by Yasmeen Abutaleb in Washington, Carlos Méndez in Mexico City, Christy Santhosh in Bengaluru; Editing by Jacqueline Wong, Tom Hogue and Sonali Paul
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