WASHINGTON, D.C. — The U.S. Food and Drug Administration is seeking public input on expanding the use of existing approved medicines for new diseases and patient populations, part of a broader federal effort to accelerate treatment options for chronic and underserved conditions.
The agency said it is requesting feedback from researchers, clinicians, patients, and drug developers on potential candidates for drug repurposing, particularly in cases where scientific evidence may support additional uses but limited commercial incentives have slowed regulatory approval efforts.
The initiative is tied to a broader FDA review of prescription drug labeling intended to ensure approved uses remain scientifically current and clinically relevant.
FDA Commissioner Marty Makary stated that the agency is examining ways to use existing scientific data to expand treatment availability.
“Drug repurposing can make better use of available scientific data to deliver effective treatment options for patients in need,” Makary said in a statement.
The FDA stated it is particularly interested in therapies targeting metabolic disorders, neurodegenerative diseases, substance-use disorders, rare diseases, and women’s and men’s health conditions.
The agency is also seeking information on drugs supported by preliminary clinical or preclinical evidence, including research generated through artificial intelligence and machine-learning tools.
According to the FDA, the request for information is intended in part to identify barriers that prevent companies from pursuing new approvals for older medicines, especially when publicly available research exists but financial incentives remain limited.
Federal regulators said the effort builds on several existing initiatives and laws, including the Best Pharmaceuticals for Children Act, the MODERN Labeling Act of 2020, and Project Renewal, an FDA program focused on updating oncology drug labeling.
The agency also cited a September 2025 federal health strategy report directing the FDA and the National Institutes of Health to explore broader use of repurposed drugs for chronic disease treatment.
The FDA stated that public submissions could help shape future collaborations with federal agencies including the NIH and the Centers for Medicare and Medicaid Services.
Comments and supporting materials may be submitted electronically through Regulations.gov under docket number FDA-2026-N-4492.
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