The U.S. Food and Drug Administration has launched a new initiative aimed at accelerating the development of treatments for patients with unmet medical needs by exploring new uses for existing FDA-approved medicines. The agency announced that it is seeking public input on drug repurposing opportunities across a wide range of diseases and health conditions.
Drug repurposing involves identifying new therapeutic uses, patient populations, or indications for medicines that are already approved for other conditions. Because these drugs already have established safety profiles and clinical data, repurposing them could significantly reduce the time and cost associated with bringing treatments to patients.
According to the FDA, the effort is part of a broader strategy to modernize and update labeling for approved medicines when supported by strong scientific evidence. The agency said ensuring drug labels remain clinically relevant and scientifically current could help physicians and patients make more informed treatment decisions.
FDA Commissioner Marty Makary said many patients continue to face limited treatment options despite promising scientific evidence already existing for some therapies.
“Too many patients lack effective treatment options, even when promising science exists,” Makary said in the announcement. He added that drug repurposing could help make better use of existing scientific data to expand access to effective therapies.
The FDA is inviting feedback from patients, clinicians, researchers, pharmaceutical companies, and other stakeholders regarding disease areas that should be prioritized and specific drugs that may be suitable candidates for repurposing. The agency is especially interested in cases where scientific evidence may already support a new use, but commercial incentives to pursue formal approval remain limited.
Among the priority areas highlighted by the FDA are metabolic disorders, neurodegenerative diseases, rare diseases, substance use disorders, and both women’s and men’s health conditions. The agency also encouraged stakeholders to identify additional therapeutic areas where repurposed drugs could address significant unmet medical needs.
The request for information covers several categories of evidence, including drugs with sufficient existing clinical data to support a new indication, therapies supported by preliminary clinical findings such as observational studies or case reports, and candidates backed by emerging preclinical research, including discoveries generated through artificial intelligence and machine learning technologies.
In addition, the FDA is seeking recommendations on innovative approaches for identifying repurposing opportunities and feedback on barriers that may prevent the development or adoption of repurposed medicines. The agency noted that limited financial incentives often discourage companies from pursuing updated labeling for older therapies, even when publicly available scientific evidence supports new uses.
The initiative builds on previous FDA programs and legislative authorities, including the Best Pharmaceuticals for Children Act, the MODERN Labeling Act of 2020, and Project Renewal, an FDA-led effort that has updated labeling for several oncology therapies to reflect evolving scientific knowledge.
The agency also referenced the September 2025 “Make Our Children Healthy Again” strategy report, which called for closer collaboration between the FDA and the National Institutes of Health to strengthen the use of repurposed drugs for chronic diseases and streamline clinical trial pathways for approval.
Public comments submitted through the initiative are expected to help shape future FDA policies and collaborative efforts with federal partners, including the Centers for Medicare and Medicaid Services. Stakeholders can submit electronic comments through Regulations.gov
under docket number FDA-2026-N-4492.