FDA Commissioner Marty Makary warned that the United States is losing ground to China in early‑stage drug development and called for reforms to speed trial starts, citing bottlenecks in hospital contracting, ethical review timelines and IND submission processes. Makary suggested the agency is exploring partnerships with health systems and academic centers to streamline pre‑IND interactions. Senate HELP Committee chair Sen. Bill Cassidy proposed complementary reforms aimed at improving U.S. competitiveness, including faster trial approvals, expanded use of real‑world data and clarified criteria for clinical holds. The remarks and proposals highlight growing political attention on regulatory throughput and global R&D competitiveness; stakeholders will scrutinize proposed structural changes and their impact on trial quality and patient safety.