FDA says it will maintain Makary’s focus on clinical trials, rare diseases and China despite leadership exits

The Food and Drug Administration announced that, even after the recent resignations of Commissioner Marty Makary and the heads of its drug and biologics centers, it will keep pursuing the policy agenda set by Makary.

According to a senior FDA official, the administration’s priorities include accelerating clinical trial timelines, expanding access to treatments for rare diseases, and strengthening collaborations with China.

The statement suggests that the agency intends to continue using user‑fee programs and other mechanisms to support these goals, signaling continuity despite the turnover in senior leadership.

Industry observers note that maintaining this focus could affect drug development timelines and market entry strategies for companies targeting rare conditions or seeking Chinese partnerships.