FDA Urged to Halt Acceptance of Chinese Phase 1 Clinical Trials Amid Growing Scrutiny

A prominent voice in the biotech sector, Jason Kelly, has called for a significant shift in U.S. drug regulation, suggesting the Food and Drug Administration (FDA) should cease accepting Phase 1 clinical trials conducted in China. Kelly, whose professional background in biotech lends weight to his statements, asserted in a recent social media post, "Agree. FDA should just not accept phase 1 trials from China if want to stop this in its tracks. Would be pretty easy." This proposal comes amidst increasing U.S. scrutiny over the integrity and geopolitical implications of medical research originating from China.

The FDA currently allows the acceptance of foreign clinical study data to support Investigational New Drug (IND) applications, provided these studies adhere to Good Clinical Practice (GCP) standards and the data can be validated through on-site inspections if deemed necessary. However, a growing "wary eye" on China has emerged, driven by concerns over data reliability and national security. The U.S. Justice Department recently implemented a new rule restricting access to sensitive biometric and genomic data from "countries of concern," including China, though clinical trials were initially exempt. This policy has since been tightened, with the FDA announcing a halt to new studies involving the transfer of American citizens' living cells to China for genetic engineering.

China has rapidly advanced its clinical trial landscape, surpassing the U.S. as a leading hub for drug research. The nation is actively positioning itself as a biotech leader, with significant investment in novel medicines and a substantial pipeline in areas like cancer and obesity drug development. This growth contrasts with recent trends in the U.S., where federal funding cuts are anticipated to impact clinical trial activity. In response, China's National Medical Products Administration (NMPA) is also streamlining its regulatory processes, proposing to halve clinical trial review periods from 60 to 30 days.

Despite the FDA's increasing willingness to approve drugs based on international data (sometimes without U.S. participants), it has maintained a tougher stance on trials conducted exclusively in China. The agency previously rejected a lung cancer drug from Eli Lilly and Innovent Biologics, citing the need for testing in a U.S.-applicable population. Kelly's suggestion highlights a desire to further restrict reliance on early-phase data from China, potentially impacting the global drug development pipeline and accelerating a decoupling of pharmaceutical research efforts between the two nations.