US Lawmakers Urge FDA to Scrutinize Chinese Gene Therapy Trial Data Amid Death Reports

U.S. Republican lawmakers are demanding that the Food and Drug Administration (FDA) thoroughly review data from gene therapy clinical trials conducted in China. The concern stems from reports of three fatalities during these trials, two of which involved children. In a joint letter to the FDA's acting director, Kyle Diamantas, Representative John Moolenaar, chairman of the Select Committee on the Strategic Competition Between the United States and the Chinese Communist Party, and Ben Cline, a member of the House Energy and Commerce Committee's Subcommittee on Health, warned of "real risks to patients" if Chinese clinical data is accepted without stringent verification.

The lawmakers expressed alarm that the Chinese medical and biotechnology trial system might consider child deaths an acceptable cost for conducting rapid and inexpensive research. They argue that outsourcing early-stage clinical trials to China could inadvertently reward this system. To mitigate these risks, the representatives urged Diamantas to prohibit the use of Chinese trial data for Investigational New Drug (IND), New Drug Application (NDA), and Biologics License Application (BLA) submissions unless the trial sites have undergone FDA on-site inspections within one year prior to the submission.

The article, sourced from Liberty Times and referencing Reuters, highlights a growing tension over the reliance on foreign clinical trial data, particularly from China, in the drug approval process. The call for stricter scrutiny reflects broader concerns about the transparency and ethical standards of medical research conducted in China.

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Accepting Chinese clinical data poses real risks to patients.