**FDA Takes Immediate Action to Review Clinical Trials Involving American Biological Samples Sent Overseas**
In a significant move aimed at safeguarding sensitive genetic data and restoring public trust, the U.S. Food and Drug Administration (FDA) has announced an immediate review of new clinical trials that involve the transfer of American citizens' living cells to China and other nations deemed hostile.
This action follows emerging evidence suggesting that some trial participants were not adequately informed about the international transfer and genetic manipulation of their biological materials, which raises serious ethical and security concerns.
The background of this issue stems from a data security rule finalized under the Biden Administration in December 2024, which was subsequently implemented in April 2025 by the U.S. Department of Justice.
While the rule introduced export controls intended to mitigate the transfer of sensitive data to adversarial countries, it also included a controversial exemption. This exemption permitted U.S. companies to send trial participants’ biological samples, including DNA, overseas for processing as part of FDA-regulated clinical trials.
Alarmingly, this exemption applied even to organizations partially controlled by the Chinese Communist Party, which has escalated fears around the potential misuse of Americans' genetic information.
FDA Commissioner Dr. Marty Makary expressed serious concerns about the previous administration's oversight, stating, “The previous administration turned a blind eye and allowed American DNA to be sent abroad — often without the knowledge or understanding of trial participants.” He emphasized the importance of integrity within the biomedical research enterprise, noting, “We are taking action to protect patients, restore public trust, and safeguard U.S. biomedical leadership.”
This review is particularly crucial for stakeholders in the pharmaceuticals, biotechnology, and medical device manufacturing sectors. The FDA's decision will require all companies involved in these trials to demonstrate a commitment to transparency, ethical consent, and compliance with domestic handling protocols for sensitive biological materials.
New trials that cannot meet these rigorous standards will face prohibitions on their advancement, a significant pivot for clinical practices that may have operated with fewer restrictions in the past.
Moreover, the FDA is collaborating with the National Institutes of Health (NIH) to ensure that federally funded research remains shielded from the risks associated with these practices. The agency is also contemplating additional enforcement measures and policy reforms to tighten the controls surrounding biological data transfers.
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.
For manufacturers in the pharmaceutical and biotechnology fields, this shift presents both challenges and opportunities. It underscores the imperative need for compliance with evolving regulatory landscapes, as well as the importance of patient consent and data security in research initiatives.
As the FDA intensifies its scrutiny, companies will need to reassess their clinical trial protocols and ensure that participant rights and data integrity are prioritized.
Industry stakeholders should stay informed about further developments from the FDA and be prepared to adapt their practices accordingly, as the agency’s review process unfolds and new regulations come into play. Ensuring ethical compliance and prioritizing patient trust will be essential in sustaining innovation and leadership in America's biomedical sector.