China has been expanding its biotechnology sector, becoming a frequent partner for major pharmaceutical companies, while the US government seeks to reduce the industry's connections with Chinese firms, according to a July 2 report. The two groups have distinct motivations: pharmaceutical companies see China as a valuable source of innovation for drug development, while the government focuses on protecting against biosecurity risks.
Recent US policy moves reflect these concerns. Last year, President Donald Trump signed the BIOSECURE Act into law after delays threatened its passage. The law restricts contracts with certain Chinese biotechnology companies that are considered national security threats. Although the final version of the legislation did not name specific companies, it still requires US drug developers to move away from some Chinese contractors in order to receive federal funding.
Additional measures include tariffs and investigations into imported pharmaceuticals. A Section 232 investigation determined that dependence on imported medicines poses a national security risk; however, exemptions were granted for some companies based on their pricing agreements with the White House.
Representative John Moolenaar recently sent letters to several major pharmaceutical firms expressing concern about clinical trials conducted in China and requesting information about data protection and due diligence regarding studies at military hospitals or in sensitive regions such as Xinjiang. One possible outcome could be legislation limiting US company operations at certain Chinese trial sites.
Industry leaders have voiced concerns about unintended consequences from restrictive policies. "I do worry about unintended consequences and effectiveness of trying to put bans in place," said John Crowley, CEO of BIO. He questioned whether such efforts might distract from making American biotech more competitive globally.
In response to these challenges, federal agencies are working together on initiatives aimed at strengthening domestic research capacity. On June 22, the Food and Drug Administration announced an investigational new drug pilot program designed to expedite early-stage research within the United States—a move described by Mike Davis of FDA's Center for Drug Evaluation and Research as part of a broader Department of Health and Human Services effort involving multiple agencies.
