China Runs More Drug Trials Than America. The FDA Says It Can No Longer Trust Data From Sites It Can't Inspect.

In May 2025, a six-year-old girl became the first person in the world to receive a gene-editing therapy aimed directly at her brain. She had Snijders Blok-Campeau syndrome, a rare developmental disorder, and the trial ran out of Xinhua Hospital in Shanghai, affiliated with Shanghai Jiao Tong University. Seven days later she was dead, of a severe immune reaction the hospital would later tie directly to the treatment. Her death was never made public. When the researchers published related animal work in a major journal months on, they left her out of it entirely, and the world found out only because someone leaked it. It would take the FDA longer still to say, in writing, that it wants to see inside trials like hers before it trusts what they produce.

She was not the only one. A young boy with Duchenne muscular dystrophy died in August 2025 after an experimental CRISPR therapy, his death recorded as acute respiratory distress following a high-dose viral-vector infusion; the sponsor, HuidaGene, disclosed it a year later, in August 2026. An adult with systemic sclerosis died after an in-vivo CAR-T treatment, announced by the company RiboX that same month. Three patients, three separate Chinese investigator-initiated trials, two of them children, and in every case the death reached the outside world through a company statement or a reporter, never a timely disclosure.

On September 2, 2026, four of the FDA’s most senior officials, the acting directors of its drug and biologics centers among them, published a short editorial built on a long-overdue premise. Its central sentence is the plainest thing the agency has said about foreign trials in years: “Before the FDA opens the door to let a product reach the American market, sponsors and clinical investigators must open their doors to the FDA.” Access to the sites. Access to the records, the source data, the consent forms. No inspection, no trust.

Read past the bureaucratic calm and the editorial contains an admission. For some foreign inspections, the directors write, the agency “has been denied access” outright, or told that to inspect at all it would first have to sign agreements limiting what it could examine, or attesting to “geopolitical principles” unrelated to the science. A domestic trial site expects the FDA at the door; that access is part of the price of selling into the American market. Abroad, the agency has instead been handed a document to sign before it can look at anything.

How did data the FDA cannot inspect come to sit underneath American drug approvals in the first place? The short answer is arithmetic. In 2010, fewer than 8 percent of the world’s clinical trials ran in China. By 2020, China had passed the United States in the number of trials registered each year. Running a study there is cheaper and faster, and for a decade the industry treated the provenance of the data as someone else’s problem.

The someone else turned out to be Congress. In late August, Representatives John Moolenaar and Ben Cline wrote to acting FDA commissioner Kyle Diamantas with two blunt requests: refuse clinical data from China unless the trial site had recently passed an FDA audit, and go back and review every product already approved on the strength of Chinese results. “The offshoring of early-stage clinical trials to China,” they wrote, “risks rewarding a system that has shown it is willing to treat children’s deaths as an acceptable cost of faster, cheaper research.”

None of this is new to the FDA, which is what makes the editorial read less like a discovery than a confession. In February 2022, the agency’s own oncology advisers voted 14 to 1 against a cancer drug called sintilimab, whose entire pivotal trial had been run in China. The drug worked. The objection was that a study done in one country, on one population, at sites that had never had a full FDA inspection and by investigators who had barely interacted with the agency, was not a foundation for treating American patients. The FDA had already spelled out its terms for accepting single-country data: it had to apply to the U.S. population, come from investigators of recognized competence, and be verifiable by on-site inspection. The third condition is the one now in doubt, and it has been for four years.

So the obvious question is what changed, and the honest answer is: not much, yet. The September editorial names no country. It names no company. What it offers is a list of intentions, more bioresearch-monitoring inspectors at the FDA’s China office and elsewhere, more reviewer training, remote assessments where its people cannot travel, more findings made public. Good intentions, every one, and not one of them is a rule. Sponsors “should treat the inability to inspect,” the directors write, “as a material factor in their regulatory strategy, not an administrative footnote.” Should. The verb is carrying an enormous load.

There is a version of this story in which an agency corrects itself, and a version in which it writes down what it already knew after three families had buried the evidence. The editorial that finally said sponsors must open their doors ran sixteen months after a six-year-old was wheeled into an operating room in Shanghai and died within the week. It does not use her name. It does not use the word China. It reads, in the end, like a very carefully worded promise to start asking the questions the agency had every right to ask all along.

Sources

1. FDA Voices – “Good Clinical Practices Are Not Optional” (Sept. 2, 2026)
2. BioSpace – Lawmakers urge FDA to enact new China policies after 3 gene therapy deaths
3. Caixin Global – Patient deaths in China trials spur U.S. demand for FDA scrutiny (Aug. 25, 2026)
4. The Cancer Letter – ODAC votes 14:1 against sintilimab; China data not generalizable to U.S. (Feb. 2022)
5. Pharmaceutical Technology – FDA unease over marketing applications based on single-country trials
6. BioSpace – FDA raises bar for foreign site inspections as China trials surge