FDA Signals Tighter Scrutiny of Early-Stage Data from China
核心洞察
FDA is balancing congressional demands to restrict Chinese early-stage clinical data against multinational biopharmas that rely on China for global drug development.
Two House lawmakers asked Acting Commissioner Kyle Diamantas in an Aug. 20 letter to reject data from Chinese sites not inspected within 12 months.
FDA rarely conducts good clinical practice inspections before marketing applications are submitted, so the requested standard would effectively ban Chinese data.
FDA is trying to chart a path between congressional China hawks who want it to reject early-stage clinical data from China, or condition acceptance on inspecting every Chinese trial site, and multinational biopharmas that have made China an almost indispensable part of global drug development. Patients in the U.S. have interests on both sides: shifting first-in-patient trials overseas can delay access to the latest treatments, while putting speed bumps in front of international clinical research could slow the pace of innovation.
Reps. John Moolenaar (R-Mich.), chair of the House Select Committee on China, and Ben Cline (R-Va.) asked FDA in an Aug. 20 letter to Acting Commissioner Kyle Diamantas to stop accepting clinical data generated in China from sites that had not been inspected within the previous 12 months. Under current practices and with existing manpower, that standard would effectively ban data from China. FDA rarely conducts good clinical practice (GCP) inspections prior to submissions of marketing applications.