Comment from Tiffany Franke

Docket No. FDA-2026-N-4492 Regarding Drug Repurposing for Unmet Medical Needs Nomination of Racemic Ketamine Hydrochloride (IV) for Label Indication in Major Depressive Disorder (MDD) Please find full comments in the attached PDF format. Comment Summary: This comment urges the FDA to prioritize evaluation of intravenous (IV) ketamine for Major Depressive Disorder (MDD) as part of its initiative on drug repurposing for unmet medical needs. Drawing on eight years of experience caring for more than 2,500 patients and administering approximately 40,000 infusions, the submission highlights the experiences of individuals with severe, often treatment-resistant depression who have exhausted conventional options including antidepressants, psychotherapy, hospitalization, and electroconvulsive therapy. The submission describes a clinical model for IV ketamine treatment for depression, and explains how rigorous safety standards, medically supervised administration, psychological support, and measurement-based longitudinal care contribute to the significant outcomes patients experience. Enclosed patient testimonials describe substantial improvements in depression, suicidality, functioning, relationships, and overall quality of life. Yet because IV ketamine remains off-label, insurance coverage is often limited, forcing many individuals to delay treatment, discontinue medically appropriate care, pursue less effective alternatives, or seek lower-cost at-home ketamine options that the FDA itself has warned may present safety concerns when used without appropriate medical supervision. The submission argues that FDA recognition of IV ketamine for MDD could meaningfully expand access to an evidence-supported treatment for millions of Americans living with depression while supporting safer, more consistent, and more sustainable models of care.