特朗普政府饱受争议的FDA疫苗负责人再次离职


更新于:2026年3月7日 / 美国东部时间上午7:28 / 美联社

美国食品药品监督管理局(FDA)备受争议的疫苗负责人维奈·普拉asad博士将再次离开该机构——这是不到一年时间内他第二次因涉及疫苗和罕见病专科药物评审的争议决定而离职。

FDA专员马蒂·马卡里周五晚间通过电子邮件向FDA员工宣布了这一消息,称普拉asad将于4月底离职,重返加州大学旧金山分校(UCSF)从事学术工作。

去年7月,普拉asad因与生物技术高管、患者团体以及总统唐纳德·特朗普的保守派盟友发生冲突而短暂离职。不到两周后,在卫生部长小罗伯特·F·肯尼迪(Robert F. Kennedy Jr.)和马卡里的支持下,他重新回到岗位。

普拉asad此次离职是一系列备受瞩目的争议事件的结果,这些争议涉及FDA对疫苗、基因疗法和生物技术药物的评审。多家公司批评该机构出尔反尔,在某些情况下甚至要求对之前已获监管机构批准的产品进行重新试验。

过去一个月,普拉asad因该机构的多项决定遭到制药高管、投资者、国会议员和其他批评者的猛烈抨击。

维奈·普拉asad博士。 Marvin Joseph/The Washington Post via Getty Images

首先,普拉asad最初拒绝允许FDA评审制药巨头莫德纳公司(Moderna)研发的备受期待的mRNA流感疫苗。这一申请被拒在FDA极为罕见,促使莫德纳公开这一决定并誓言正式挑战该决定。

一周后,FDA突然反转,称在莫德纳进行额外研究后将接受该疫苗的评审。

随后,在过去一周,FDA与一家开发亨廷顿舞蹈症实验性疗法的小型药企爆发了罕见的公开冲突。亨廷顿舞蹈症是一种致命疾病,在美国影响约4万人。

UniQure公司周一表示,FDA要求其基因疗法进行新试验,其中涉及对部分试验患者进行假手术。该公司的基因疗法需通过手术直接注射入大脑。

公司高管称,要求假手术对照试验与FDA先前的指导方针相矛盾,并引发了患者伦理担忧。

周四,FDA召开了罕见的新闻发布会,批评该公司疗法并为其要求额外研究辩护。

一位要求匿名的FDA高级官员向记者表示,该公司的原始研究”彻头彻尾失败”。

“我们这里有一个失败的产品,”他补充道。

FDA在讨论科学分歧时,通常会通过经过严格审查的书面声明进行沟通,尤其是在涉及仍在审查中的实验性药物的情况下。

普拉asad担任FDA疫苗和生物技术最高监管官员期间,与被监管公司发生了一系列类似纠纷。

已有六家以上研究罕见病或难治性疾病疗法的药企收到拒绝信或要求开展额外研究的通知,这可能使它们的开发计划延长数年,并增加数百万美元的成本。

作为长期的学术研究者和FDA药物评审标准的批评者,普拉asad自去年5月加入FDA以来,其监管方法让许多FDA观察家和批评者感到困惑。

多次场合中,普拉asad与马卡里共同宣布加快和简化FDA药物评审流程的措施,但同时也对一些生物技术药物和疫苗(特别是新冠疫苗)施加了新的警告和研究要求。新冠疫苗长期以来一直是肯尼迪的批评目标,而肯尼迪在加入特朗普政府前是长期的反疫苗活动家。

Trump administration’s embattled FDA vaccine chief is leaving again

Updated on: March 7, 2026 / 7:28 AM EST / AP

The Food and Drug Administration’s embattled vaccine chief, Dr. Vinay Prasad, is once again leaving the agency — the second time in less than a year that he’s departed after controversial decisions involving the review of vaccinations and specialty drugs for rare diseases.

FDA Commissioner Marty Makary announced the news to FDA staff in an email late Friday, saying Prasad would depart at the end of April. Makary said Prasad would return to his academic job at the University of California, San Francisco.

In July, Prasad was briefly forced from his job after running afoul of biotech executives, patient groups and conservative allies of President Donald Trump. He was reinstated less than two weeks later with the backing of Health Secretary Robert F. Kennedy Jr. and Makary.

Prasad’s latest ouster follows a string of high-profile controversies involving the FDA’s review of vaccines, gene therapies and biotech drugs in which companies have criticized the agency for reversing itself, in some cases calling for new trials of products previously greenlighted by regulators.

In the last month, Prasad has come under fire from pharmaceutical executives, investors, members of Congress and other critics for multiple decisions at the agency.

Dr. Vinay Prasad. Marvin Joseph/The Washington Post via Getty Images

First, Prasad initially refused to allow the FDA to review a highly anticipated flu vaccine from drugmaker Moderna made with mRNA technology. The rejection of the application, highly unusual for the FDA, prompted Moderna to go public with Prasad’s decision and vow to formally challenge it.

A week after the rejection became public, the FDA reversed course and said it would accept the shot for review after all, pending an additional study from Moderna.

Then, in the past week, the FDA engaged in a highly unusual public fight with a small drug company developing an experimental treatment for Huntington’s Disease, a fatal condition that affects about 40,000 people in the U.S.

The company, UniQure, said Monday that the FDA was demanding a new trial of its gene therapy that would involve performing a sham surgery on some of the patients in the trial. The company’s gene therapy is injected directly into the brain during a surgical procedure.

Company executives said the request for a sham-controlled trial contradicted previous FDA guidance and raised ethical concerns for patients.

On Thursday, the FDA held a highly unusual press conference with reporters to criticize the company’s therapy and defend the agency’s request for an additional study.

A senior FDA official, who requested anonymity to speak with reporters, called the company’s original study “stone cold negative.”

“We have a failed product here,” he added.

The FDA typically communicates in carefully-vetted written statements when speaking about scientific disagreements, especially those involving experimental drugs that are still under the agency’s review.

Prasad’s time as the FDA’s top vaccine and biotech regulator has been marked by a series of similar disputes with the companies the agency regulates.

More than a half-dozen drugmakers studying therapies for rare or hard-to-treat diseases have received rejection letters or requests to run additional studies, adding years and potentially many millions of dollars to their development plans.

A longtime academic and critic of the FDA’s standards for drug reviews, Prasad’s approach to regulation since arriving at the FDA last May has confounded many FDA observers and critics.

On repeated occasions, Prasad joined Makary in announcing steps to make FDA drug reviews faster and easier for companies. But he also has imposed new warnings and study requirements for some biotech drugs and vaccines, particularly COVID shots that have long been a target for Kennedy, a longtime anti-vaccine activist before joining the Trump administration.

评论

发表回复

您的邮箱地址不会被公开。 必填项已用 * 标注