The FDA announced on May 11, 2026 that it is soliciting input on drug repurposing—finding new uses, indications, or patient populations for drugs that are already FDA-approved. The agency said the effort focuses especially on chronic or rare diseases where promising scientific evidence exists but commercial incentive to pursue a formal new approval may be limited.
The request invites input from patients, clinicians, researchers, and other stakeholders. Repurposing can sometimes move faster than developing a brand-new therapy from scratch, and it creates a formal opening for patient communities to describe unmet needs and evidence.
What advocates should watch
Coordinate submissions around priority conditions, patient-reported outcomes, real-world evidence, and labeling updates that would make clinicians more comfortable prescribing evidence-supported options. Note Federal Register deadlines and ask whether FDA will publish summaries of patient comments.
Related: FDA release, Federal Register notice.
Submitting effective comments
Patient comments carry more weight when they include documented unmet need, harms from delayed access, and real-world use data—even case series—from treating clinicians.
Note insurance barriers separately: FDA repurposing discussions do not by themselves change payer coverage or prior authorization requirements.
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