June 19, 2025

On June 18, 2025, the U.S. Food and Drug Administration (FDA) announced a significant policy update that is sending ripples through the biomedical and clinical research communities. The agency has placed a hold on new clinical trials that involve exporting biological materials, specifically, human cells derived from American participants, for genetic modification in foreign laboratories located in “China and other hostile countries”.

In the press release formally announcing this directive, FDA commissioner, Dr. Marty Makary was quoted on the matter, stating “The integrity of our biomedical research enterprise is paramount. We are taking action to protect patients, restore public trust, and safeguard U.S. biomedical leadership.”

A Shift in Oversight and Motivation Behind the Pause

The agency stated this action follows “mounting evidence” of instances where participant cells were shipped abroad without fully informed consent or where participants were not clearly told how their biological materials would be used. This raised red flags not only about ethical oversight but also about the ability of the U.S. government to monitor the use and protection of sensitive data once it leaves national borders.

The updated guidance also appears to align with broader national security policies under the current administration. Lawmakers and officials have increasingly expressed unease over foreign access to American genetic and biomedical data, especially in countries with opaque scientific or regulatory infrastructures. The FDA emphasized that this pause is not a ban, but rather a deliberate and temporary halt to allow for a comprehensive review of how these trials are proposed and conducted. The agency will be reviewing all clinical trials that fall under this ban and will require companies to demonstrate full transparency, ethical consent, and domestic handling of sensitive biological materials to proceed. New trials that cannot meet these standards will not be permitted.

For biotech companies and research firms, the FDA’s directive presents a complex new hurdle. Many institutions rely on specialized foreign laboratories for critical components of clinical research, particularly in gene therapy trials that involve editing human cells. These partnerships often exist because of cost efficiencies or because certain capabilities are more advanced abroad.

Now, with a pause in place, organizations will need to reassess how and where they conduct certain types of research. Some may need to bring key aspects of their trials back onshore, while others will likely seek out new partnerships in countries with regulatory frameworks more aligned with U.S. standards. This will almost certainly lead to delays in some clinical trial timelines and may increase costs associated with domestic sourcing and processing.

That said, there could be long-term advantages. For years, there has been a call to strengthen the domestic biotechnology infrastructure in the U.S.; to invest in facilities, workforce development, and technology that would reduce reliance on overseas labs. This pause could act as a catalyst for this change. The increased demand for U.S.-based capabilities may drive domestic investment and innovation, while also reinforcing participant protections and public confidence in the U.S. clinical trial process.

At present, the FDA has not specified how long the pause will last, nor has it released a list of countries deemed “hostile” or the exact criteria by which foreign labs will be evaluated. More guidance is expected in the coming weeks, as stakeholders seek clarity on the requirements for restarting paused trials or submitting new ones.

In the meantime, the clinical research ecosystem is entering a period of recalibration. Sponsors and investigators will need to review current and planned protocols, especially those involving international collaboration. Ethics boards and institutional review committees may also face increased scrutiny as they consider how participant consent is obtained and documented.