US lawmakers push FDA to tighten rules on Chinese clinical data after three gene therapy deaths

Three recent deaths in separate gene‑therapy trials in China have prompted two members of the U.S. House of Representatives to call on the FDA for new safeguards.

Representatives John Moolenaar and Ben Cline sent a letter to Acting FDA Commissioner Kyle Diamantas asking the agency to reject Chinese clinical data unless the trial site has undergone a recent FDA audit and to review any U.S. approvals that relied on such data.

The lawmakers warned that offshoring early‑stage trials to China could reward a system that appears willing to accept patient deaths as a cost of faster, cheaper research. The House Select Committee on China and the BIOtech Caucus have not yet responded to the request.