US lawmakers ask the FDA to stop taking Chinese trial data on trust

Representatives John Moolenaar, who chairs the House Select Committee on the Chinese Communist Party, and Ben Cline wrote to Acting FDA Commissioner Kyle Diamantas on 21 August 2026 with two requests. The agency should decline clinical data generated in China for investigational and marketing applications unless the trial site has been audited by the FDA within the previous twelve months, and it should review the products already approved in the United States that rested on Chinese trial data.

The letter is built on three deaths. A boy with Duchenne muscular dystrophy died in August 2025 after a high systemic dose of HuidaGene’s CRISPR therapy HG302, developing acute respiratory distress syndrome. A six-year-old girl with Snijders Blok-Campeau syndrome died seven days after receiving the first gene-editing therapy directed at the brain, from a severe immune reaction, in May 2025. A patient with systemic sclerosis died after receiving RiboX Therapeutics’ in vivo CAR-T therapy, disclosed on 9 August 2026.

A letter from two members is not policy. What it puts a price on is the disclosure lag: each of these deaths surfaced long after it happened, and the argument being made is that a regulator cannot weigh data from sites it has never inspected.