Chinese clinical trials have become synonymous with speed and savings, but questions have surfaced about the price of those advantages.
Reports surfaced over the summer of three deaths in Chinese trials, including two children — but the deaths were not publicly disclosed when they occurred.
In a letter to FDA Acting Commissioner Kyle Diamantas, Rep. John Moolenaar, chairman of the House Select Committee on China, and Rep. Ben Cline laid out their concerns in stark terms.
“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,” they wrote. “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.”
The company involved in the third case, RiboX, said the FDA was aware of the death, which was included as part of its IND submission.
All three deaths occurred in investigator-initiated trials, or IITs, which operate outside China’s traditional IND process. The first death, in August 2025, involved a boy being treated for Duchenne muscular dystrophy in a CRISPR gene-editing trial run by Shanghai-based HuidaGene. The second involved a 6-year-old girl with a genetic neurodevelopment disorder, who underwent a gene-editing procedure targeting her brain at Xinhua Hospital. The third patient was a man in his 50s with systemic sclerosis and “significant pre-existing medical conditions,” who was treated with RiboX’s experimental in vivo CAR-T cell therapy.
China had already taken steps to erect more guardrails around these IITs through Order 818, which went into effect on May 1, before the deaths were publicized.
Before the order, IIT trials in China were “in a bit of a Wild West,” Boyang Wang, founder of the global longevity fund Immortal Dragons, previously told PharmaVoice.
The 818 order formally established a parallel commercial pathway for certain treatments, including gene editing and personalized cell therapies, outside the traditional drug approval process. It also requires companies using the pathway to partner with Level 3 Grade A hospitals and bars them from charging patients for experimental treatments until they clear a preliminary efficacy and safety bar called “translational approval.” Foreign companies remain subject to existing investment restrictions, and their access to the pathway remains a gray area.
What lawmakers want from FDA
Clinical trial volume has increased rapidly in China. The country surpassed the U.S. in annual trial registrations by 2020 and reached more than 5,000 registered trials per year by 2024. But China’s willingness to be forthright about potential safety issues in clinical trials remains a concern, Moolenaar and Cline said in their letter. They want to see the FDA take a more active role in monitoring data coming out of the country, which could be used to support approvals for American drugs.
“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,” they wrote.
The lawmakers asked the FDA to decline China-generated data for investigational new drug applications, new drug applications or biologics license applications unless the agency had conducted an in-person audit of the trial site within the 12 months before submission. They also requested a comprehensive risk assessment of U.S. drug development and marketing approvals that rely on Chinese IITs and Clinical Trial Applications, with special attention to high-risk modalities such as gene editing.
The FDA is reviewing the letter, according to an email from the HHS Public Affairs office.
“The FDA appreciates congressional interest and partnership in restoring United States dominance in drug development,” HHS said. “The Agency is in receipt of this letter and it is under review for response.”
This issue arises as U.S. officials are trying to accelerate domestic trials to compete with China, which can move drugs from early research to investigational new drug application 50% to 70% faster than other nations.
Operation TrialBlazer, which launched earlier this year, includes a proposed pilot program to expedite IND timelines and more quickly get drugs into human trials.
“The Agency is also taking steps to clarify phase 1 expectations and streamline more flexible late-stage trial designs,” HHS said.
