The FDA is seeking public input on drug repurposing efforts aimed at expanding treatment options for diseases tied to unmet medical needs.
The agency said identifying new uses for FDA-approved drugs could accelerate treatment availability by relying on existing safety and scientific data, according to a May 11 FDA news release. The initiative is part of a broader effort to update drug labeling when supported by sufficient evidence.
The FDA is requesting feedback from patients, clinicians and researchers on disease areas and approved drugs that may warrant additional study or labeling changes. The agency said it is particularly interested in metabolic diseases, neurodegenerative conditions, women’s and men’s health conditions, substance use disorders and rare diseases.
The request also seeks information on drugs with existing clinical or preclinical evidence that could support new indications, including findings generated through AI and machine learning tools. FDA Commissioner Marty Makary, MD, said in the release that drug repurposing could help deliver treatment options more quickly for patients lacking effective therapies.
The effort builds on other federal initiatives tied to drug labeling and repurposing, including the Modern Labeling Act of 2020 and Project Renewal, an FDA initiative focused on updating oncology drug labels. The agency also cited the September 2025 Make Our Children Healthy Again strategy report, which directed the FDA and National Institutes of Health to explore expanded use of repurposed drugs for chronic disease treatment.
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