Comment from Ginger Cloud

Re: Docket No. FDA-2026-N-4492, Drug Repurposing for Unmet Medical Needs I am writing as a licensed mental health, addictions counselor, and trained ketamine-assisted psychotherapist. I am member of a 600+ member professional organization dedicated to ketamine-assisted psychotherapy (PsyKe), and as someone with 4 years experience practicing psychotherapy with ketamine patients as well as an instructor for a ketamine-assisted psychotherapy course at the University of Vermont. I wholeheartedly encourage the FDA to prioritize ketamine as a candidate for drug repurposing for mental health conditions. Ketamine is already FDA-approved as an anesthetic and has been used in clinical medicine for decades, resulting in a well-characterized safety profile when administered in appropriate settings. Over the past two decades, a substantial body of scientific literature has demonstrated that ketamine can produce rapid and clinically meaningful improvements in depressive symptoms and suicidal ideation, including in patients who have not responded to conventional treatments. Numerous randomized controlled trials, meta-analyses, and real-world clinical studies now support its effectiveness in carefully selected patients under medical supervision. Ketamine appears to fit the type of candidate described in this Request for Information. There is a significant unmet medical need in mental health care, particularly among individuals with treatment-resistant conditions who may wait weeks or months for conventional antidepressants to take effect, if they respond at all. At the same time, ketamine's clinical use for these conditions has expanded substantially despite the lack of a corresponding FDA-approved indication for generic ketamine. This creates a disconnect between scientific evidence, clinical practice, and regulatory approval. Further, high quality training programs have existed for years to prepare clinicians of various types to work with ketamine. One of the most significant barriers resulting from the absence of an approved indication is insurance coverage. Many patients who could benefit from ketamine treatment are unable to access it because they must pay out of pocket. As a result, access is often limited to individuals with financial means rather than those with the greatest clinical need. Updating ketamine's labeling to reflect the available evidence could facilitate broader insurance coverage, reduce disparities in access, and improve public health outcomes. I have personally witnessed many clients benefit from ketamine treatment when combined with psychotherapy, for a range of mental health diagnoses. Most of the clients I have worked with during this time sought ketamine treatment after trying a wide range of therapies and medications over many years with minimal benefit. The ability of ketamine to help with treatment resistant problems, and even mild to moderate mental health conditions has renewed my hope for integrated medical and mental health models of care, attending to whole person health. I encourage the FDA to review the existing literature and consider whether the available evidence meets the standard for a new indication or otherwise warrants action through the drug repurposing pathways discussed in this notice. I also encourage reflection on mechanisms that might be leveraged to encourage ketamine administration in combination with psychotherapy. Ketamine represents a compelling example of a long-approved medication with substantial evidence supporting an important new use that addresses a serious and ongoing unmet medical/mental health need. In appreciation of your time and consideration, Ginger Cloud, LCMHC, LADC Vermont