What Is the FDA’s Clinical Trial Export Halt? Consent, Cell Use and Cross-Border Risks

The FDA has paused new clinical trials that involve exporting Americans’ living cells to laboratories in countries deemed hostile, including China. The decision, announced June 18, 2025, follows concerns that participants may not have been informed about how their cells would be handled or that their cells could be genetically engineered abroad and re-infused into their bodies in the US.

FDA Commissioner Dr. Marty Makary described the move as necessary to “protect patients, restore public trust and safeguard US biomedical leadership.” The agency is reviewing trials that relied on a now-suspended exemption created under the Biden Administration, which allowed biological material transfers abroad, even involving entities linked to the Chinese government.

Although a December 2024 data security rule limited such transfers, an exception had permitted them for FDA-regulated trials — sometimes without the participant’s awareness.

This policy applies to a process commonly used in cell and gene therapy trials, where a patient’s cells are extracted, modified in a lab and then returned for treatment. When this is done overseas without explicit informed consent, it can raise questions about data privacy, patient autonomy and oversight requirements.

For many years, US trials have relied on outsourcing — from contract research organizations (CROs) to contract development and manufacturing organizations (CDMOs) — to reduce costs and accelerate timelines. Countries like China and India have been key destinations due to speed and infrastructure. In 2024, China conducted over 7,100 trials, surpassing the US, which ran around 6,000. Factors contributing to this include streamlined approvals and government-backed investment in biotech.

Since taking office, Makary has emphasized greater transparency and clinical ethics, advancing policies on informed consent and regulatory accountability. The FDA’s latest move builds on these efforts.

It also aligns with two recent executive orders, which set the rules for tighter control of biological data and research. Executive Order 14117 restricts the export of sensitive personal data — including genetic material — to foreign entities, even if encrypted, if it remains linkable to individuals. Executive Order 14292 ends federal support for gain-of-function and other high-risk biological research in countries that do not meet comparable oversight standards.

In an analysis of US–China relations, the Council on Foreign Relations (CFR) noted that China has become a global manufacturing hub and a major competitor in high-tech sectors.

Prior to the FDA’s announcement, in April, China reportedly deepened its biotech ties with Japan through joint ventures and licensing deals, showcasing a broader strategy to diversify collaborations beyond the US.

Early this year, US pharma companies also signed an increasing number of licensing deals with Chinese biotech firms. In the first half of 2025, 14 such deals — potentially worth $18.3 billion — were signed, according to GlobalData figures shared exclusively with Reuters. These agreements provide US companies with access to experimental oncology and obesity drugs developed in China and reflect a continued commercial relationship alongside increased regulatory scrutiny.

Biotech firms have been key drivers of outsourced research, particularly in cell and gene therapy.

The global CRO market, valued at $65 billion in 2024, is projected to exceed $113 billion by 2031. The global clinical trial outsourcing market was valued at approximately $43.1 billion in 2024 and is projected to reach $91.2 billion by 2033, growing at a compound annual growth rate (CAGR) of 7.46%.

 While North America currently holds the largest share, the Asia–Pacific region is expanding rapidly. Major providers such as IQVIA, ICON, Parexel and Syneos operate across global markets to meet growing demand.

It remains unclear how many trials will be affected by the new FDA mandate. The agency has not identified specific programs. What is known is that new trials involving overseas cell handling will need to meet higher standards for consent and domestic processing.

This policy shift has real teeth: it could prompt companies to reassess cross-border strategies, expand US-based operations and reconsider future investments.

If you want your company to be featured on Xtalks.com, please email [email protected].