Moolenaar to FDA: "Chinese Clinical Data Poses Real Risks for Patients"
Chairman John Moolenaar of the Select Committee on China (R-MI) and Congressman Ben Cline (R-VA) have sent a letter to Acting Commissioner Kyle Diamantas of the Food and Drug Administration (FDA) calling on the agency to stop the use of drug trial data from China for new clinical trial or drug applications unless the FDA has inspected the trial site in the past 12 months. The letter follows the tragic news of three deaths – including two children – that were covered up in drug trials in China.
The lawmakers, who are both members of a House Appropriations subcommittee that oversees the FDA, write:
“We note with grave concern recent reporting that has exposed three separate, tragic deaths of patients—two of them children—enrolled in experimental gene-editing investigator-initiated trials (IITs) in China. In one case, the sponsoring company halted all public updates about the treatment for more than a year and only acknowledged the death after persistent inquiries. In another, researchers concealed a child’s death and went on to publish scientific findings without disclosing the fatal outcome. In the third case, the patient died in March 2026, yet in early August 2026 the FDA reportedly cleared the therapy to begin clinical trials in the United States —without the company ever having publicly reported the death.
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This matters for the FDA because American pharmaceutical companies are increasingly incorporating China‑generated clinical trial data into submissions for U.S. drug development or acquiring or licensing therapies from Chinese companies based on tests run in China. Just as the United States does not accept goods manufactured with forced labor under the Uyghur Forced Labor Prevention Act (UFLPA), we should not accept clinical data that exposes patients to risks and harms that would never be permitted under FDA oversight.
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China now conducts thousands of clinical trials annually, but the American public has almost no visibility into how these trials are run, how data are collected, or whether adverse events are fully disclosed.
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American families deserve confidence that the treatments approved in our country are supported by data produced with rigor, ethics, and accountability. We cannot outsource that responsibility to a CCP-controlled system that does not share our standards or our values."
The letter calls on the FDA to:
- Decline acceptance of China‑generated clinical trial data for U.S. Investigational New Drug (IND) applications, New Drug Applications (NDA), or Biologics License Applications (BLA) unless the FDA has conducted an in-person audit of the trial site within the last twelve months prior to application submission.
- Conduct a comprehensive risk assessment examining the extent to which U.S. drug development and marketing approvals rely on data from Chinese IITs and Clinical Trial Applications (CTA), with special attention to high‑risk modalities like gene editing—and publish the results for public review.
Read the full letter here.