GOP lawmakers urge FDA to tighten scrutiny of Chinese clinical-trial data after reported deaths

Republican Reps. John Moolenaar of Michigan and Ben Cline of Virginia urged the FDA to impose tougher checks on clinical-trial data generated in China.

Their request follows reports of three previously undisclosed patient deaths in Chinese investigator-initiated gene-editing or cell-therapy trials, including two children.

The lawmakers asked the FDA to reject China-generated data for U.S. investigational-new-drug, new-drug, or biologics applications unless the relevant trial site had undergone an FDA on-site inspection within the previous 12 months.

They also called for a public risk assessment of how heavily U.S. drug development and approvals rely on Chinese clinical-trial data, with particular attention to high-risk technologies such as gene editing.

The demand is currently a congressional request, not an announced FDA policy change. It could increase regulatory uncertainty for biotech companies relying on China-based trial data.