Context:

FDA Commissioner Marty Makary has raised concerns that the U.S. is lagging behind China in early-stage drug development, citing cumbersome processes as major bottlenecks. He highlighted issues with hospital contracting and ethical reviews that delay the initiation of clinical trials, which hampers the U.S.'s competitiveness. With China now conducting more clinical trials and accounting for a significant share of new drug approvals, Makary emphasized the need for reforms to expedite trial approvals, including potential collaborations with health systems. The FDA is committed to exploring solutions to enhance innovation and improve patient access to new therapies. Continued pressure on U.S. policymakers suggests a critical need to address these challenges to regain leadership in the global biotech landscape.

Dive Deeper:

• Marty Makary indicated that the U.S. is significantly behind China in early-phase clinical trials, with 2024 data highlighting this disparity.

• He identified three primary bottlenecks: hospital contracting processes, ethical review delays, and inefficiencies in the Investigational New Drug application process.

• Makary noted that China now conducts more clinical trials than the U.S. and is expected to reach 35% of FDA drug approvals by 2040.

• The FDA is exploring partnerships with health systems and academic centers to streamline the pre-IND process.

• The FDA's commitment to reform comes amid bipartisan calls for enhancing domestic innovation in drug development.

• China's rise as a global innovation leader has been fueled by significant state investment and accelerated regulatory reforms.

• Data from Global Data and Morgan Stanley supports concerns about the U.S.'s declining position in the global drug development landscape.