health
February 18, 2026
FDA Chief Warns U.S. Is Losing Ground to China in Early Drug Development, Calls for Faster Trial Approvals
Makary pointed to three bottlenecks: hospital contracting, ethical reviews and approvals and the Investigational New Drug applications process
TL;DR
- FDA Commissioner Marty Makary believes the U.S. is behind China in early-stage drug development.
- He identified hospital contracting, ethical reviews/approvals, and the Investigational New Drug (IND) application process as key bottlenecks.
- Makary called these processes "clunky" and uncompetitive compared to faster-moving countries like China.
- China's biotech ecosystem has flourished due to state investment, talent, and regulatory reforms, leading to more clinical trials and drug approvals.
- Data indicates China conducts more clinical trials than the U.S. and accounts for nearly a third of new global drug approvals.
- Makary expressed a desire to partner with health systems and academic centers to improve the pre-IND process.
- He believes boosting domestic innovation is a bipartisan goal that can be achieved by the current administration.
- U.S. policymakers are under pressure to enhance domestic innovation.
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