FDA has announced the suspension of certain new clinical trials, pending immediate review, in which United States citizens’ living cells are sent to China and other “hostile countries,” as the agency said in a press release, for genetic engineering and subsequent re-infusion into US patients (1). The cells’ transport and infusions are often carried out, FDA said, without these patients’ knowledge or consent.
Biden-era rule, Trump-era tweak
Key Takeaways
- FDA has suspended some new clinical trials involving US patients’ cells sent to countries such as China for genetic engineering, citing security and consent concerns.
- Under Commissioner Marty Makary, FDA is enacting reforms: streamlining US manufacturing approvals, prioritizing “human-relevant” testing, and enhancing public trust.
- The Biden-era data security rule and recent Trump-era directives highlight ongoing tensions between clinical research globalization and safeguarding US biomedical leadership.
The action by FDA has its roots in the closing days of the administration of President Joe Biden, namely a data security rule finalized by that administration in December 2024 and enacted by the US Department of Justice in April 2025, under President Donald Trump’s administration.
While the Biden-era rule was designed to implement export controls that would limit the transfer of sensitive data to—in FDA’s words—“countries of concern,” the agency says that the previous administration requested and received an exemption that allowed US companies to send clinical trial biological samples, including DNA, overseas for processing (1). FDA says that some of the involved overseas companies are partially owned or controlled by the Communist Party in China.
“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 Marty Makary, MD, in the press release (1). “The integrity of our biomedical research enterprise is paramount. We are taking action to protect patients, restore public trust, and safeguard US biomedical leadership.”
Sea change at FDA
FDA has announced numerous policy changes since the appointment of Makary as commissioner on April 1, 2025 (2). On April 10, the agency said it intended to replace animal testing in development of monoclonal antibody therapies and other drugs with more effective, “human-relevant” methods (3). A week later, Makary issued a policy directive limiting employees of companies regulated by FDA, such as pharmaceutical companies, from serving as official members of FDA advisory committees, an attempt to boost public trust in FDA decisions (4).
On May 5, in an executive order also governing the Environmental Protection Agency, the Trump administration directed FDA to take steps to reduce the time needed to approve pharmaceutical manufacturing plants located in the US, including eliminating “duplicative and unnecessary” requirements, streamlining the review process, and working with domestic manufacturers to offer early support before a facility comes online (5). And on June 17, FDA announced the creation of the Commissioner’s National Priority Voucher program to help shorten the review times for drug approvals (6).
Yet there have been some FDA approvals that are juxtaposed with directives issued from elsewhere in the Trump administration. On May 31, the agency approved mRNA-1283, a new, lower-dose messenger RNA COVID-19 vaccine by Moderna that will be marketed as mNEXSPIKE (7). But that was just days after US Health and Human Services Secretary Robert F. Kennedy Jr. said the federal government would remove a recommendation that children and pregnant women get routine COVID-19 vaccines, a disclosure that reportedly blindsided staff at the Centers for Disease Control and Prevention (8,9).
References
1. FDA. FDA Halts New Clinical Trials That Export Americans’ Cells to Foreign Labs in Hostile Countries for Genetic Engineering. Press Release. June 18, 2025.
2. FDA. Martin A. Makary, MD, MPH, Sworn in as FDA Commissioner. Press Release. April 1, 2025.
3. FDA. FDA Announces Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Other Drugs. Press Release. April 10, 2025.
4. FDA. FDA Commissioner Makary Announces New Policy on Individuals Serving on FDA Advisory Committees. Press Release. April 17, 2025.
5. The White House. Fact Sheet: President Donald J. Trump Announces Actions to Reduce Regulatory Barriers to Domestic Pharmaceutical Manufacturing. WhiteHouse.gov, May 7, 2025.
6. FDA. FDA to Issue New Commissioner’s National Priority Vouchers to Companies Supporting U.S. National Interests. Press Release. June 17, 2025.
7. Moderna. Moderna Receives U.S. FDA Approval for COVID-19 Vaccine mNEXSPIKE. Press Release. May 31, 2025.
8. Secretary Kennedy (@SecKennedy) on X. X.com, May 27, 2025 (accessed June 2, 2025).
9. Huang, P. and Stein, R. CDC Recommends Parents Talk to a Doctor About Getting COVID-19 Shots for Kids. NPR.org, May 30, 2025 (accessed June 2, 2025).
