Wednesday, June 18, 2025 -- The U.S. Food and Drug Administration (FDA) today announced an immediate review of new clinical trials that involve sending American citizens’ living cells to China and other hostile countries for genetic engineering and subsequent infusion back into U.S. patients – sometimes without their knowledge or consent..

2025年6月18日，星期三——美国食品药品监督管理局（FDA）今天宣布立即审查涉及将美国公民的活体细胞送往中国及其他敌对国家进行基因工程改造，并随后注入美国患者体内的新临床试验——有时未经他们的知情或同意。

This action by the FDA follows mounting evidence that some of these trials failed to inform participants about the international transfer and manipulation of their biological material and may have exposed Americans’ sensitive genetic data to misuse by foreign governments including adversaries.

美国食品药品监督管理局的这一行动是因为有越来越多的证据表明，其中一些试验未能告知参与者其生物材料的国际转移和操作，可能让包括敌对国家在内的外国政府滥用美国人的敏感基因数据。

This practice was made possible by a data security rule finalized under the Biden Administration in December 2024 and implemented in April 2025 by the U.S. Department of Justice. While the rule imposed export controls to limit sensitive data transfers to countries of concern, the Biden Administration specifically requested and approved a sweeping exemption that allowed U.S.

这项做法得以实现，得益于拜登政府在2024年12月最终确定并于2025年4月由美国司法部实施的数据安全规则。尽管该规则实施了出口管制以限制向重点关注国家的敏感数据转移，但拜登政府特别请求并批准了一项广泛的豁免，允许美国...

companies to send trial participants’ biological samples — including DNA — for processing overseas as part of FDA-regulated clinical trials. This exemption applied even in cases involving companies partially owned or controlled by the Chinese Communist Party..

公司将其临床试验参与者生物样本（包括DNA）送到海外进行处理，作为FDA监管的临床试验的一部分。即使在涉及部分由中国共产党拥有或控制的公司的情况下，这项豁免也适用。

“The previous administration turned a blind eye and allowed American DNA to be sent abroad — often without the knowledge or understanding of trial participants,” said FDA Commissioner Dr. Marty Makary. “The integrity of our biomedical research enterprise is paramount. We are taking action to protect patients, restore public trust, and safeguard U.S.

“上届政府视而不见，允许美国的基因数据被送往国外——通常试验参与者并不知情或不了解，”FDA专员马蒂·马卡里博士说。“我们生物医学研究机构的诚信至关重要。我们正在采取行动保护患者，恢复公众信任，并保障美国的利益。”

biomedical leadership.”.

生物医学领导力。”

The FDA is actively reviewing all relevant clinical trials that relied on this exemption and will require companies to demonstrate full transparency, ethical consent, and domestic handling of sensitive biological materials. New trials that cannot meet these standards will not proceed.

美国食品药品管理局 (FDA) 正在积极审查所有依赖该豁免的临床试验，并将要求公司证明完全透明、符合伦理的知情同意以及对敏感生物材料的国内处理。无法满足这些标准的新试验将不会进行。

The agency is also working closely with the National Institutes of Health (NIH) to ensure that no federally funded research is compromised by these practices. Additional enforcement and policy measures could be forthcoming.

该机构还与美国国立卫生研究院 (NIH) 密切合作，以确保任何联邦资助的研究都不会因这些做法而受到影响。可能会出台更多的执法和政策措施。

This action is part of a broader national effort to implement Executive Orders 14117 and 14292, which direct the federal government to prevent the exploitation of sensitive biological data by foreign adversaries and ensure research funding flows only to secure, transparent, and U.S.-compliant institutions..

这项行动是实施行政命令14117和14292的更广泛全国努力的一部分，这些命令指示联邦政府防止敏感生物数据被外国对手利用，并确保研究资金仅流向安全、透明且符合美国规定的机构。

The National Institutes of Health is fully aligned with the FDA in this administration’s mission to uphold the highest standards of transparency, ethics, and scientific rigor.

美国国立卫生研究院完全支持FDA，共同致力于实现本届政府坚持的透明度、道德和科学严谨性的最高标准。

“In light of the FDA’s actions and new information surrounding the Biden Administration’s egregious policies, the National Institutes of Health is actively reviewing its entire research portfolio to determine whether any federally funded clinical trials utilized the exemption issued under the Biden Administration that allowed American biological materials to be sent abroad for genetic modification – particularly to entities operating in countries of concern,” said NIH Director Dr.

“鉴于FDA的行动以及围绕拜登政府恶劣政策的新信息，美国国立卫生研究院正在积极审查其整个研究组合，以确定是否有任何联邦资助的临床试验利用了拜登政府发布的豁免令，该豁免令允许将美国的生物材料送往国外进行基因改造，特别是送往在令人担忧的国家运营的实体，”NIH主任博士说道。

Jay Bhattacharya..

贾伊·巴塔查里亚

“Our goal is to protect Americans’ sensitive biological data while continuing to support life-saving innovation in a way that is safe, secure, and worthy of the public’s trust.” Bhattacharya said. “This exemption requested created a dangerous blind spot in our research security that put the privacy and trust of American participants at risk.

“我们的目标是保护美国人的敏感生物数据，同时继续以安全、可靠且值得公众信任的方式支持挽救生命的创新。” Bhattacharya说。 “所要求的这一豁免在我们的研究安全中造成了一个危险的盲点，使美国参与者的隐私和信任面临风险。”

We are assessing the scope of this issue to ensure that no NIH dollars are supporting clinical trials that compromise data integrity, patient consent, or national security.”.

我们正在评估这个问题的范围，以确保没有美国国立卫生研究院的资金被用于支持破坏数据完整性、患者同意或国家安全的临床试验。

About the National Institutes of Health (NIH):

关于美国国立卫生研究院 (NIH)：

NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases.

美国国立卫生研究院（NIH）是国家的医学研究机构，包括27个研究所和中心，是美国卫生与公众服务部的组成部分。NIH是主要的联邦机构，负责开展和支持基础、临床和转化医学研究，并致力于研究常见和罕见疾病的病因、治疗方法和治愈手段。

For more information about NIH and its programs, visit www.nih.gov..

有关 NIH 及其计划的更多信息，请访问 www.nih.gov。

Source: FDA

来源：FDA

Whatever your topic of interest,

无论你感兴趣的话题是什么，

subscribe to our newsletters

订阅我们的新闻通讯

to get the best of Drugs.com in your inbox.

获取 Drugs.com 的最佳资讯到您的收件箱。