Makary Proposes Higher FDA User Fees for Non-US Phase I Trials to Counter China Biotech

FDA Commissioner Marty Makary proposes higher user fees for companies conducting Phase I trials outside the US, such as in China, to incentivize domestic drug development1234.

Makary highlighted that China launched 3x more Phase I trials than the US last year and expressed distrust in Chinese Phase III trial data integrity1.

This 'America-first' agenda is part of PDUFA VIII renewal negotiations starting in 2026, aiming to support US innovation and reshore clinical programs134.

FDA is considering options to lower fees for small US-based companies while adding fees for overseas development14.

Industry leaders express concerns over FDA leadership turnover potentially ceding biotech leadership to China4.

Sources:

1. https://www.biospace.com/policy/makary-eyes-america-first-user-fee-structure-as-renewal-negotiations-approach

2. https://ground.news/article/making-us-biotech-more-competitive-with-chinas-could-help-rare-disease-patients-experts-say

3. https://hallorancg.com/insights/rush-to-phase-1-considerations-for-initial-regulatory-interaction

4. https://www.fiercebiotech.com/biotech/fda-floats-user-fee-cuts-early-stage-us-trials-additional-fees-overseas-development