CNBC – Health & Science

FDA Chief Warns U.S. Is Losing Ground to China in Early Drug Development, Calls for Faster Trial Approvals

FDA Commissioner Marty Makary warned that the United States is falling behind China in early‑stage drug development, citing slower Phase 1 trial volumes and cumbersome regulatory steps. He identified three primary bottlenecks—hospital contracting, ethical review processes, and the IND application workflow—that delay trial start‑ups. Makary urged the FDA to streamline approvals, explore pre‑IND collaborations with health systems, and accelerate the overall trial pipeline. Data from Global Data and Morgan Stanley show China now runs more clinical trials than the U.S. and could account for 35% of FDA approvals by 2040.