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Saturday, January 11, 2025

Lawmakers urge tighter controls on US-China clinical trial collaborations

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Congressman John Moolenaar Chairman of the Select Committee on the CCP | Official U.S. House headshot

Congressman John Moolenaar Chairman of the Select Committee on the CCP | Official U.S. House headshot

Chairman John Moolenaar, Ranking Member Raja Krishnamoorthi, and Representative Neal Dunn have addressed a letter to Secretary of Commerce Gina Raimondo. The letter urges the Department of Commerce to revise its regulations concerning clinical trials conducted with Chinese military hospitals.

In mid-2024, these lawmakers sought information from the FDA about clinical trials at Chinese military hospitals. They also inquired about FDA site visits in China and trials occurring in Xinjiang, where allegations of genocide against the Uyghur people have been raised.

The lawmakers expressed concerns over potential misuse of biotechnology by the Chinese Communist Party against the United States. They stated, “While the chemical compounds of drugs in development and related IP are not export controlled, [the Bureau of Industry and Security’s] proposed update to toughen military end-user and end-use controls could be strengthened to specifically state that cooperation with PLA medical institutions for the purpose of clinical trials is subject to a licensing requirement.”

Furthermore, they recommended updating definitions within current regulations. They suggested that “Specifically, we recommend updating the definition of ‘Military End User’ to state medical infrastructure owned or operated by the national armed services of the PRC and other countries as appropriate constitutes a military end-use if a U.S. person is seeking to engage with the institution to conduct a clinical trial.”

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