Comment from Shilpa Thirukkovalur

I am submitting this comment in response to FDA Docket No. FDA-2026-N-4492, "Drug Repurposing for Unmet Medical Needs." I respectfully ask the FDA to evaluate intravenous (IV) ketamine as a candidate for drug repurposing for treatment-resistant depression and other severe depressive illnesses. I understand that ketamine is already FDA approved for other medical uses, but IV ketamine for depression remains an off-label treatment. Based on my experience, this off-label status creates meaningful barriers for patients, even when treatment is prescribed and administered by qualified medical professionals in a structured clinical setting. Over the past six years working in behavioral healthcare, I have met colleagues and fellow mental health advocates whose lives have been transformed by IV ketamine therapy. Many have described their recovery as feeling like a fog had lifted and that they finally felt like themselves again, with the motivation and energy to engage in the activities they love. Others have shared that ketamine treatment was what made therapy finally "click," giving them the relief they needed to fully engage in therapy and make lasting lifestyle and behavioral changes that supported their recovery. I have also lived with depression for most of my life, so I understand firsthand how life-changing the right mental health treatment can be. I have been fortunate that my own treatment has been covered by insurance, which has spared me from having to choose between financial stability and receiving the care I need. I currently work for a company that provides IV ketamine treatment for patients with treatment-resistant depression, though the views expressed here are my own. At my company, patients receive individualized care from skilled clinicians and are closely monitored throughout each infusion. Our clinical teams also coordinate with patients' mental health providers to help ensure continuity of care. However, many patients require periodic maintenance infusions, making the cost of treatment a significant barrier because it is typically not covered by insurance. If IV ketamine were approved for depression, it could help reduce barriers to care, support broader access to treatment, and make it easier for more patients to receive this option under the guidance of qualified medical professionals. For individuals who have not found relief with existing treatments, expanding access to evidence-based options could have a meaningful impact on their quality of life. Thank you for your consideration of this important issue.