FDA Commissioner Makary Warns of US Lagging Behind China in Biotech Amid Proposed Budget and Reforms
FDA Commissioner Marty Makary warned that the US is falling behind China in drug development, with China conducting more clinical trials and accounting for nearly a third of new global drug approvals.
Makary urged the Trump administration to partner with pharma industry to streamline trials and address bottlenecks.
Makary proposed an 'America-first' user fee structure, charging higher fees to companies not conducting Phase I trials in the US to incentivize domestic innovation.
Makary testified at the Senate Appropriations Committee hearing on the FDA's 2026 budget request.
Health Secretary Robert F. Kennedy Jr. praised Makary's efforts to prevent China from stealing the US biotech industry.
China leads in early-stage asset generation and Phase I trials, with global firms expanding operations there due to faster, cheaper trials.