FDA Commissioner Makary Calls for IRB Reforms to Match China Trial Speed

FDA Commissioner Marty Makary is pushing for "big and different" reforms to the institutional review board (IRB) process that oversees clinical trials, warning that the US risks ceding leadership in early-stage drug development to China.

At a CMS conference in Baltimore, Makary noted that the pre-IND (Investigational New Drug) phase can run up to 380 days in the US, while China is pushing for just 60 days. That gap puts American biotech at a significant competitive disadvantage, he argued.

The FDA has been working to streamline its own processes, but Makary says the broader IRB system — which reviews and approves clinical trials at hospitals and research institutions — needs fundamental reform to keep pace with China's rapidly advancing pharmaceutical sector.

China has seen increased biotech investments, licensing deals, and faster early-phase clinical trial starts. The country's regulatory environment has become increasingly supportive of rapid drug development, attracting both domestic and international pharmaceutical companies.

Makary has previously cited higher FDA user fees as one potential tool to counter China's biotech growth, arguing that increased resources could help the agency move faster while maintaining safety standards.

The push for IRB reform comes as part of a broader effort by the FDA to modernize clinical trial infrastructure and reduce regulatory bottlenecks that slow the initiation of critical studies.