Stakeholders urge FDA to create drug-repurposing framework that avoids disincentives and stays within authority

Stakeholders, including patients and healthcare industry groups, told the FDA that repurposing existing drugs offers significant opportunities for new treatments.

They warned that any new repurposing framework must avoid discouraging investment or competition and must operate within the agency's existing statutory authority.

The article also cited a Health Affairs study showing that China approved more oncology drugs than the United States between 2020 and 2025, while the U.S. regulator led in first‑in‑class approvals and generally approved products faster.