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# FDA Input Sought on Drug Repurposing
- URL: https://www.fdaweb.com/fda-input-sought-on-drug-repurposing/
- Published: 2026-05-11T12:00:00.000Z
- Updated: 2026-09-14T13:38:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161121

FDA is seeking public input on ways to expand drug repurposing efforts, aiming to accelerate treatment options for patients with unmet medical needs by identifying new uses for already approved medicines. In an announcement released Monday, FDA said it is requesting information from patients, clinicians, researchers and other stakeholders on disease areas and drug candidates that could benefit from repurposing efforts, particularly in cases where sufficient scientific evidence may exist but limited commercial incentives have prevented companies from pursuing new approvals.

FDA said the initiative is part of a broader effort to modernize labeling for approved drugs so prescribing information remains scientifically current and clinically meaningful. “Too many patients lack effective treatment options, even when promising science exists,” said commissioner Marty Makary. “Drug repurposing can make better use of available scientific data to deliver effective treatment options for patients in need.”

Drug repurposing involves identifying new indications or patient populations for medicines already approved by the agency. Because the drugs’ safety profiles and manufacturing characteristics are often already well characterized, repurposing can shorten development timelines compared with entirely new drug programs.

The agency said it is especially interested in feedback involving disease areas with substantial unmet need, including metabolic diseases, neurodegenerative disorders, substance use disorders, rare diseases and women’s and men’s health conditions.

FDA is requesting information on three categories of potential repurposing candidates: drugs for which sufficient evidence may already support a new use; drugs with promising preliminary clinical evidence, such as observational studies or case reports; and candidates supported by emerging preclinical findings, including research generated through artificial intelligence and machine learning tools.

The agency also asked stakeholders to identify barriers that may discourage development of repurposed drugs, particularly when publicly available scientific evidence exists but commercial incentives for pursuing formal labeling changes are limited.

The initiative builds on several existing FDA authorities and programs intended to support evidence-based labeling updates, including the Best Pharmaceuticals for Children Act, the MODERN Labeling Act of 2020 and Project Renewal, an FDA effort focused on updating labeling for older oncology drugs.

FDA also pointed to the 9/2025 “Make Our Children Healthy Again” strategy report, which directed the agency to work with the National Institutes of Health on opportunities to strengthen the use of repurposed drugs for chronic diseases and streamline regulatory pathways through collaborative clinical trial designs.

According to the agency, information submitted through the public docket will help shape future FDA policies on evaluating and facilitating additional drug repurposing opportunities, including collaborations with federal partners such as the Centers for Medicare and Medicaid Services.