在过去的几个月里，FDA内部发生了包括FDA局长辞职、CDER、CBER等中心主任辞职、裁员近3500人等诸多变化，堪称动荡。这些变化影响着FDA监管工作的开展：Over the past few months, there have been numerous changes within the U.S. Food and Drug Administration (FDA) .Here is a chronological listing from the news articles, press releases, press conferences, Google searches and LinkedIn posts I have read from November 2024 to April 2025. This snapshot highlights the significant number of changes in a relatively short amount of time, and I acknowledge that additional changes may well occur before this article is published.在过去的几个月里，FDA内部发生了诸多变化。以下是 2024 年 11 月至 2025 年 4 月期间FDA所发生的的事件列表。这一简要梳理凸显了在相对较短的时间内发生的大量变化：Nov. 14— President-elect Donald J. Trump nominated Robert F. Kennedy, Jr., to be the next secretary of the Department of Health and Human Services (HHS). HHS is the parent department of the FDA, making this pick a bit controversial since Kennedy has been an antivaccine proponent for more than 30 years. Upon accepting the nomination, Kennedy said, “I look forward to working with the more than 80,000 employees at HHS to free the agencies from the smothering cloud of corporate capture so they can pursue their mission to make Americans once again the healthiest people on Earth.”11 月 14 日 —— 当选总统特朗普提名小罗伯特・F・肯尼迪为下一任卫生与公众服务部（HHS）部长。HHS 是FDA的上级部门，由于肯尼迪 30 多年来一直是反疫苗倡导者，这一提名颇具争议。在接受提名时，肯尼迪表示：“我期待与 HHS 的 8 万多名员工合作，将这些机构从企业控制的窒息氛围中解放出来，使他们能够继续履行使命，让美国人再次成为地球上最健康的人。”Nov. 22— President-elect Trump nominated Martin A. Makary, MD, MPH, to be the next commissioner of the FDA. Makary is a surgeon, professor, author and medical commentator. His nomination was also somewhat controversial as, during the COVID-19 pandemic, Makary was a regular on Fox News criticizing the FDA.11 月 22 日 —— 当选总统特朗普提名马丁・A・马卡里为下一任FDA局长。马卡里是一名外科医生、教授、作家和医学评论员。他的提名也颇具争议，因为在新冠疫情期间，马卡里是福克斯新闻的常客，经常在节目中批评FDA。Jan. 18— Director of the Center for Drug Evaluation and Research (CDER) Patrizia Cavazzoni, MD, retired from the FDA, citing family obligations as her reason for leaving.1 月 18 日 —— FDA药物评价和研究中心（CDER）主任帕特里齐亚・卡瓦佐尼医学博士宣布从 FDA 离休，她称离休原因是家庭责任。Jan. 20— Trump was inaugurated as the 47th President of the United States of America.1 月 20 日 —— 特朗普宣誓就任美国第 47 任总统。Jan. 20— Robert M. Califf, M.D., resigned from his position as FDA commissioner in accordance with the customary transition to a new presidential administration. In his farewell post on X (formerly known as Twitter), Califf wrote, “I leave with the satisfaction that much has been accomplished, that consumers and patients are better off, because of our staff’s work during my tenure—guiding the regulated industries to do a better job of producing products that improve health while reducing adverse effects. The hard work we have made in terms of structural changes will help us better deal with future challenges. Commissioners come and go, but this workforce is the foundation for much of American health and well-being. You can be sure that I will be cheering them on from the sidelines and looking to help where I can.”1 月 20 日 —— 罗伯特・M・卡利夫医学博士辞去FDA 局长职务。卡利夫在社交平台 X（原推特）上发表告别帖称：“我离任时感到欣慰，因为在我的任期内，我们的员工付出了努力，完成了许多工作，让消费者和患者的处境得到了改善 —— 我们引导受监管行业更好地生产既能改善健康又能减少不良反应的产品。我们在结构改革方面所做的努力将帮助我们更好地应对未来的挑战。局长任期有始有终，但 FDA 的员工队伍是美国公众健康和福祉的重要基石。请相信，我将在幕后为他们加油，并随时准备在力所能及的范围内提供帮助。”Jan. 21— The Trump administration imposed a freeze on all communications from federal health agencies that affected regulations, guidance documents, announcements, press releases and posts on websites and social media.1 月 21 日 —— 特朗普政府冻结了联邦卫生机构所有涉及法规、指导文件、公告、新闻稿以及网站和社交媒体帖子的通信。Jan. 31— Trump signed an executive order mandating the repeal of 10 existing rules, regulations or guidance documents for every new one issued.1 月 31 日 —— 特朗普签署了一项行政命令，规定每发布一项新的规则、条例或指导文件，就必须废除 10 项现有的相关文件。Feb. 13— Kennedy was confirmed as the secretary of the Department of Health and Human Services.2 月 13 日 —— 肯尼迪获正式任命为美国卫生与公众服务部部长。Feb. 15— Probationary employees at the FDA were terminated. Although the exact number of individuals affected was unclear, estimates suggested that approximately 700 employees were impacted, including 220 from the Center for Devices and Radiological Health (CDRH).2 月 15 日 —— FDA 的试用期员工被解雇。尽管受影响的确切人数尚不清楚，但据估计约有 700 名员工受到影响，其中包括来自器械和放射卫生中心（CDRH）的 220 人。Feb. 21— The Center for Biologics Evaluation and Research (CBER) announced the resignation of its deputy director, Celia Witten, MD, PhD. Julia (Julie) Tierney, JD, who previously served as the FDA chief of staff, was appointed as the new deputy director.2 月 21 日 —— 生物制品评估和研究中心（CBER）宣布其副主任西莉亚・威滕医学博士辞职。曾担任过FDA办公厅主任的朱莉娅・（朱莉）・蒂尔尼法学博士被任命为新的副主任。Feb. 22— HHS staff were instructed to email their managers and the Office of Personnel Management with a list of five things they accomplished that week. Elon Musk, then-senior advisor to the President, posted on X: “Those who do not take this email seriously will soon be furthering their career elsewhere.” This mandate was later rescinded.2 月 22 日 —— 美国卫生与公众服务部（HHS）的员工被要求给他们的经理和人事管理办公室发电子邮件，列出他们在那周完成的五件事。当时的总统高级顾问埃隆・马斯克在 X 平台上发帖称：“那些不把这封邮件当回事的人，很快就会去别处发展他们的事业了。” 这一指令后来被撤销了。Feb. 24— Several of the terminated probationary employees were given the opportunity to return to their positions, specifically those from the CDHR.2 月 24 日 —— 部分被解雇的试用期员工获得了重返工作岗位的机会，尤其是来自器械和放射卫生中心（CDHR）的员工。Feb. 28— Kennedy posted a notice in the Federal Register rescinding the policy on “Public Participation in Rule Making (Richardson Waiver).” This change will enable the FDA to issue new guidance and regulations without a commenting period.2 月 28 日 —— 肯尼迪在《联邦公报》上发布通知，废除了 “公众参与法规制定（理查森豁免）” 政策。这一变动将使FDA 能够在无需征求意见的情况下发布新的指南和法规。Mar. 4— On its website, the Department of Government Efficiency (DOGE) listed the closure of 30 FDA field offices, including the crucial FDA drug laboratory testing site in St. Louis, Mo. This site plays a significant role in assessing the quality of medicines and other products.3 月 4 日 —— 政府效率部（DOGE）在其网站上公布将关闭 30 个 FDA 驻外办事处，其中包括位于密苏里州圣路易斯市的关键 FDA 药品实验室检测站点。该站点在评估药品及其他产品质量方面发挥着重要作用。Mar. 5— DOGE announced that it would not be closing the 52,000 square foot facility in St. Louis, Mo.3 月 5 日 —— 政府效率部（DOGE）宣布，不会关闭位于密苏里州圣路易斯市的这座 5.2 万平方英尺的设施。Mar. 10— Trump named Jim Traficant as the new FDA chief of staff. In this role, he will oversee the day-to-today management of the agency and lead agency activities on major initiatives.3 月 10 日 —— 特朗普任命吉姆・特拉菲坎特为FDA新任办公厅主任。其职责包括监督该机构的日常管理工作，并领导机构开展重大计划相关活动。Mar. 11— Hilary Perkins was hired as FDA chief counsel. (Keep this information in mind, as it will be relevant on March 14.)3 月 11 日 —— 希拉里・珀金斯（Hilary Perkins）被聘为FDA首席法律顾问。（请记住这一信息，它与 3 月 14 日的事件相关。）Mar. 13— This was the deadline for the FDA to submit phase one of their Agency Reduction-in-Force and Reorganization Plan to the White House Office of Management and Budget.3 月 13 日 —— 这是FDA 向白宫管理和预算办公室提交其机构裁员和重组计划第一阶段内容的截止日期。Mar. 13— During FDA Commissioner nominee Martin Makary’s confirmation hearing before the Senate Health, Education, Labor and Pensions Committee, U.S. Senator Josh Hawley (R-Mo.) threatened to vote against Makary's confirmation unless FDA Chief Counsel Hilary Perkins resigned.3 月 13 日 —— FDA 局长提名人马丁・马卡里（Martin Makary）于参议院卫生、教育、劳工及养老金委员会举行的确认听证会上，美国密苏里州共和党参议员乔希・霍利（Josh Hawley）威胁称，除非 FDA 首席法律顾问希拉里・珀金斯（Hilary Perkins）辞职，否则将投票反对马卡里的任命。Mar. 13— A U.S. District Judge ruled that probationary employees who were dismissed due to performance issues should be reinstated.3 月 13 日 —— 美国一名地区法官裁定，因绩效问题被解雇的试用期员工应恢复职位。Mar. 14— Perkins resigned as FDA chief counsel.3 月 14 日 —— 珀金斯辞去FDA 首席法律顾问一职。Mar. 14— This marked the deadline for accepting the HHS voluntary resignation offer, which included a $25,000 incentive along with eight weeks of pay and benefits. However, the medical review staff were not eligible for this resignation bonus.3 月 14 日 —— 这一天是接受美国卫生与公众服务部（HHS）自愿辞职提议的截止日期。该提议包括 2.5 万美元激励金、八周工资及福利，但医疗审查人员无资格获得这笔辞职奖金。Mar. 17— FDA staff resumed full-time, in-person work at the agency’s White Oak headquarters in Silver Spring, Md. Returning employees reported overcrowding issues such as long security-checkpoint lines, limited parking spaces and insufficient office space.3 月 17 日 —— FDA的工作人员恢复了在马里兰州银泉市怀特奥克总部的全职现场工作。返回的员工报告了过度拥挤的问题，如安检口排队长、停车位有限和办公空间不足。Mar. 18— Probationary workers who were fired in February were reinstated and immediately placed on paid leave.3 月 18 日 ——2 月被解雇的试用期员工恢复职位，并立即被安排带薪休假。Mar. 25— Makary was confirmed as the next FDA commissioner in a 56-44 Senate vote.3 月 25 日 —— 参议院以 56 票赞成、44 票反对的表决结果，批准马卡里（Martin Makary）就任下一任 FDA 局长。Mar. 25— Barclay P. Butler, PhD, was named FDA deputy commissioner for operations and chief operating officer.3 月 25 日 —— 巴克莱・P・巴特勒博士（Barclay P. Butler, PhD）被任命为 FDA 运营副局长兼首席运营官。Mar. 27— HHS Secretary Kennedy revealed plans for a workforce reduction that will impact 10,000 employees, including 3,500 from the FDA.3 月 27 日 —— 美国卫生与公众服务部（HHS）部长肯尼迪透露了裁员计划，该计划将影响 10,000 名员工，其中包括来自 FDA 的 3,500 人。Mar. 28— Makary was sworn in as the 27th commissioner of the FDA.3 月 28 日 —— 马卡里（Martin Makary）宣誓就任 FDA 第 27 任局长。Mar 28— Peter Marks, MD, PhD, director of the CBER, resigned from the FDA. In his farewell letter, he urged Americans to uphold the scientific endeavors dedicated to their well-being. He ended his resignation letter by saying, “My hope is that during the coming years, the unprecedented assault on scientific truth that has adversely impacted public health in our nation comes to an end so that the citizens of our country can fully benefit from the breadth of advances in medical science.”3 月 28 日 —— 生物制品评估和研究中心（CBER）主任彼得・马克斯医学博士辞去了 FDA 的职务。在告别信中，他呼吁美国人支持旨在维护自身健康的科学事业。他在辞职信的结尾写道：“我希望在未来几年里，对科学真理的空前冲击能够结束，这种冲击已对我国公共卫生产生不利影响。”Apr. 1— Approximately 3,500 FDA staff were fired as part of the HHS reduction-in-force (RIF) action. Inspectors and reviewers were not impacted by the RIF; however, many of the operational staff supporting reviews and inspections were. The layoffs included staff at all levels within the agency and, in some cases, entire departments.4 月 1 日 —— 作为美国卫生与公众服务部（HHS）裁员行动的一部分，约 3500 名FDA 员工被解雇。检查员和审查员未受裁员影响，但许多支持审查和检查工作的运营人员则在裁员范围内。此次裁员涉及该机构各级员工，在某些情况下甚至包括整个部门。Apr 3— A plan to reorganize the FDA was leaked. The plan proposed to eliminate the product-specific centers and divide the FDA into five competency areas: the Office of Product Evaluation and Regulation, the Office of Inspections, Compliance and Enforcement, the Office of Scientific and Regulatory Policy, the Office of Administrative and Shared Services, and the Office of Strategic Programs and Innovation.4 月 3 日 —— 一项重组FDA的计划被泄露。该计划提议撤销针对特定产品的中心，并将 FDA 划分为五个职能领域：产品评估和监管办公室、检查与合规执法办公室、科学与监管政策办公室、行政和共享服务办公室以及战略项目和创新办公室。Apr. 8— Partial telework was reinstated for some FDA employees. Their “read and write work output” will be tracked in 15-minute increments to ensure productivity and accountability.4 月 8 日 —— 部分FDA 员工恢复部分远程办公安排。他们的 “读写工作产出” 将以 15 分钟为单位进行追踪，以确保工作效率和责任落实。Apr. 14— This was the deadline for the FDA to submit phase two of their Agency Reduction-in-Force and Reorganization Plan to the White House Office of Management and Budget.4 月 14 日 —— 这是 FDA 向白宫管理和预算办公室提交其机构裁员和重组计划第二阶段的截止日期。Apr. 15— The FDA started looking for contract workers to replace the 50 fired employees responsible for supporting the Office of Inspections and Investigations. These roles were crucial in organizing travel logistics and securing translators for inspectors.4 月 15 日 —— FDA 开始寻找合同工，以取代被解雇的 50 名负责为检查和调查办公室提供支持的员工。这些岗位在组织差旅后勤以及为检查员配备翻译人员方面至关重要。Apr. 15— The FDA requested that the dismissed staff from the Center for Tobacco Products temporarily return to work after realizing they had terminated the entire office responsible for penalizing retailers who sell cigarettes and vapes to minors.4 月 15 日 —— FDA 意识到他们裁掉了整个负责对向未成年人销售香烟和电子烟的零售商实施惩罚的办公室后，请求烟草产品中心被解雇的员工暂时返岗。Apr. 17— A leaked copy of the White House budget revealed plans to slash the HHS budget by one-third, from approximately $120 billion in fiscal year 2024 to around $80 billion in fiscal year 2026.4 月 17 日 —— 一份泄露的白宫预算文件显示，计划将美国卫生与公众服务部（HHS）的预算削减三分之一，从 2024 财年的约 1200 亿美元削减至 2026 财年的约 800 亿美元。Apr 17— Two senior officials from the Office of Prescription Drug Promotion resigned: Director Catherine Gray, PharmD, and Deputy Director Mark Askine.4 月 17 日 —— FDA 处方药推广办公室的两名高级官员辞职：主任凯瑟琳・格雷（Catherine Gray，药学博士）和副主任马克・阿斯金（Mark Askine）。Apr. 17— Makary announced a new policy limiting individuals employed at companies regulated by the FDA from serving as members on FDA advisory committees.4 月 17 日 —— 马卡里（Makary）宣布了一项新政策，限制受FDA监管的公司的员工担任 FDA 咨询委员会成员。Apr. 21— The FDA hired Lowell M. Zeta as deputy commissioner & special counsel for strategic initiatives, Timothy Schell, PhD, as acting director of the Center for Veterinary Medicine, and Craig Taylor as chief information security officer.4 月 21 日 —— FDA 聘请洛厄尔・M・泽塔担任副局长兼战略计划特别顾问，聘请蒂莫西・谢尔博士担任兽医学中心代理主任，聘请克雷格・泰勒担任首席信息安全官。Apr. 22— Makary announced in a press conference, “The FDA is taking action to remove petroleum-based food dyes from the U.S. food supply and from medications.” The official press release made no mention of medications.4 月 22 日 —— 马卡里在新闻发布会上宣布：“FDA 正在采取行动，从美国的食品供应和药物中去除石油基食用色素。” 但官方新闻稿中并未提及药物。Apr. 22— At that same press conference, Kennedy responded to a question about the restoration of Freedom of Information Act (FOIA) offices, by saying, “We’re restoring all the FOIA offices and we’re going to make it much easier for people to get the information…We’re going to start a website with all former FOIA requests and the documents that were produced so people don’t have to do it again and again. And we’re going to try to get as close as we can to total transparency in this agency.”4 月 22 日 —— 在同一场新闻发布会上，肯尼迪在回答关于恢复《信息自由法》办公室的问题时表示：“我们将恢复所有《信息自由法》办公室，让人们更容易获取信息…… 我们将开设一个网站，上面有所有以前的《信息自由法》申请和生成的文件，这样人们就不必反复申请。我们将努力使这个机构尽可能达到完全透明。”Apr. 24— Alonza Cruse, the director of the Office of Human and Animal Drugs Inspectorate (OHADI), and Nancy L. Rolli, the OHADI deputy office director for strategic oversight, announced their retirement.4 月 24 日 —— 人用和动物用药品监察办公室（OHADI）主任阿朗扎・克鲁斯（Alonza Cruse）和该办公室负责战略监督的副主任南希・L・罗利（Nancy L. Rolli）宣布离休。Apr. 29— Jeremy Faust, MD, of Inside Medicine, posted his interview in which Makary stated that there would be no reorganization at the FDA. (You can read the interview here: Exclusive: In conversation with FDA Commissioner Dr. Marty Makary.)
4 月 29 日 ——《内科医学》的杰里米・浮士德医生发布了他对马卡里的采访内容，FDA局长 马卡里在采访中表示 FDA 不会进行重组。
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(https://mp.weixin.qq.com/s/blBKKtWk6NYrh_AS38ArXg)
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