Comment from Adam Fry

I am submitting this comment in response to FDA Docket No. FDA-2026-N-4492, “Drug Repurposing for Unmet Medical Needs.” I serve as Senior Director of Operations at Ember Health, an organization dedicated to providing highly professional, evidence-based IV ketamine care for people living with depression. My perspective is grounded in healthcare operations, finance, and systems redesign. I have spent my career helping build the clinical, operational, and financial infrastructure that allows better models of care to reach patients responsibly. I have seen how promising treatments succeed or fail not only on clinical merit, but on whether the surrounding infrastructure allows patients, clinicians, payers, and regulators to treat them as legitimate, durable, and accessible parts of the healthcare system. IV ketamine for depression is precisely the type of opportunity this initiative should address. Ketamine is an FDA-approved medication with a long-established safety profile in other uses, and sub-anesthetic IV ketamine for depression is supported by a substantial and growing body of clinical evidence. Yet because it remains off-label for depression, patients face barriers that are not primarily scientific; they are structural. Insurance coverage is inconsistent or unavailable. Patients who respond well often struggle to maintain care because ongoing treatment becomes a significant out-of-pocket burden. Others hesitate to pursue treatment at all because “off-label” is too easily mistaken for experimental, despite the existence of rigorous medical protocols and responsible clinical practice. In the absence of a clearer pathway, the field is also left vulnerable to inconsistent standards and less scrupulous actors, which can undermine public trust in one of the most promising treatments available for severe depression. The result is a familiar healthcare failure: not an absence of need, not an absence of promise, but an absence of fit between evidence, regulation, reimbursement, and access. I urge the FDA to prioritize IV ketamine for depression as a candidate for drug repurposing and to create a practical pathway by which existing evidence, data, and structured real-world outcomes can support appropriate labeling for depression. This pathway should not lower the evidentiary bar; it should make it possible to meet that bar for older, generic medications where no conventional commercial sponsor is likely to carry the work forward. For patients with severe depression, this is not an abstract regulatory exercise. It is the difference between a promising intervention that remains fragmented, misunderstood, and inaccessible, and a medically supervised treatment that can be integrated into a responsible, accessible, evidence-based system of care for millions of patients. The FDA has an opportunity to help close that gap and I urge you to do so. Thank you for considering my perspective and for your work to advance responsible, evidence-based pathways for patients with unmet medical needs.