The U.S. FDA launched a new initiative to advance drug repurposing, aiming to expand treatment options for patients with chronic and rare diseases where therapies remain limited. By encouraging the use of already approved medicines for new indications, the agency hopes to shorten development timelines and leverage existing safety data to bring therapies to patients faster.
FDA Commissioner Marty Makary noted that many patients still lack effective treatment options despite promising science, underscoring the need to explore new uses for existing drugs. The agency is inviting input from patients, clinicians, researchers, and industry stakeholders to identify priority areas such as metabolic disorders, neurodegenerative conditions, women's and men's health, substance use disorders, and rare diseases.
Submissions can highlight drugs with sufficient evidence for repurposing or those showing early promise in clinical or preclinical studies. The FDA is also seeking feedback on innovative approaches to identify repurposing opportunities and on barriers that may limit development, particularly in cases where commercial incentives are low.
This initiative builds on existing frameworks like the Best Pharmaceuticals for Children Act, the MODERN Labeling Act of 2020, and FDA-led programs such as Project Renewal, which has updated oncology drug labeling to reflect current science. It also aligns with broader federal strategies to strengthen pathways for chronic disease treatments.
FDA added that public input will guide the agency's next steps, including collaborations with NIH and CMS, to ensure that promising science translates into accessible therapies.
Source: FDA
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