Access to Care: The Case of Ketamine

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FROM OUR READERS

I am deeply concerned by the recent announcements regarding NRx-100 and its so-called “expanded access” policy for suicidal ideation. While the language of “expanded access” is being used to frame this initiative as a public good, in reality it is appears to be little more than a marketing buzzword that risks misleading patients, clinicians, and policymakers.

Racemic ketamine, despite decades of off-label clinical use, has never been approved by the US Food and Drug Administration (FDA) for any psychiatric indication. The claim that this new formulation somehow offers unique safety or efficacy advantages rests on the assertion that preservatives are harmful—an assertion that has yet to be robustly and independently demonstrated. NRx should be required, as every reputable pharmaceutical company has been, to produce convincing evidence that the preservative in generic ketamine is indeed a source of harm, and in addition prove through a robust clinical trial that racemic ketamine (with or without preservatives) is a safe and effective treatment for the psychiatric indications they assert. Every treatment must be supported by rigorous safety and efficacy data.

We have all felt the changes to medical research in the last 9 months, and it is curious that only now the word “preservative” is being emphasized—precisely when racemic ketamine’s off-label psychiatric use may account for a growing share of its utilization. What about its use in chronic pain, general anesthesia, or veterinary medicine? Why does NRx not seem equally enthusiastic about those domains, where ketamine’s use is broader and FDA-approved? The selective targeting of psychiatric indications raises questions about whether this strategy is motivated by patient safety or market positioning.

NRx Pharmaceuticals has engaged in a flurry of activity—filing a Citizen Petition to remove benzethonium chloride from ketamine products, pursuing Fast Track status for NRX-100, seeking patents, applying for FDA National Priority review vouchers, launching branded-generic versions, and even opening their own clinics for psychiatric delivery. If the company’s true concern is patient safety and access, then the ethical path would be to expand access under ketamine’s actual FDA-approved indication—general anesthesia—while allowing independent scientific investigation to continue evaluating its promise in depression, posttraumatic stress disorder, suicidality, and other psychiatric conditions. By trying to redefine access through regulatory maneuvers in off-label markets, rather than ensuring broad, affordable availability in its approved use, NRx risks prioritizing market positioning over genuine patient care.

Moreover, the invocation of “expanded access” in this context undermines the very definition of access to care. True access, as defined by health policy standards, means that patients should have knowledge of, and equitable access to, affordable, comprehensive, appropriate, and quality health care. When judged by these parameters, NRx-100 falls short.

The day-to-day treating psychiatrist is rarely seen as “savvy” in these debates, and too often we are made to feel that conversations about the business of medicine are not ours to have. Yet we can—and must—read between the lines and advocate strongly for our patients. This is not a good signal for psychiatry. As scientists, we follow the evidence. As clinicians, we sometimes must go with our gut. And this does not feel well intentioned.

Dr Harding is an assistant clinical professor at Yale School of Medicine, and is the medical director at the Mood Institute.