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Aug 21, 2026

GOP lawmakers call on FDA to increase scrutiny of Chinese clinical trial data after gene therapy deaths

Two Republican members of the House of Representatives are urging the FDA to reject clinical data from China unless trial sites have been recently audited by the agency, following reports of three patient deaths in separate gene therapy clinical trials conducted in China.

Aug 21, 2026·2 sources
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Top claims

  • ▪Representatives John Moolenaar and Ben Cline view clinical data from China as requiring FDA on-site audits before being accepted for regulatory purposes.
  • ▪Major delays in early phase clinical trials occur mainly at the site level rather than from the FDA.
  • ▪The boy who received HuidaGene's HG302 therapy developed acute respiratory distress syndrome in the setting of severe complement and cytokine activation following high-dose systemic administration of an adeno-associated virus vector.

Subtopics

U.S.–China relationsDrug safety

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