The Rise of Ketamine Clinics and Ketamine-Assisted Therapy
Ketamine clinics have been on the rise in the U.S. in recent years. As a byproduct of the common practice of prescribing drugs “off-label,” these clinics are not necessarily new in their operating model. Off-label use is the utilization of pharmaceutical drugs for, among other factors, unapproved indications. An approved indication occurs when the Food and Drug Administration (FDA) formally approves a given drug for a named medical condition.
Ketamine’s FDA-approved indication is “as an intravenous or intramuscular injection solution for induction and maintenance of general anesthesia”, and that’s it. However, ketamine is a Schedule III controlled substance and, in small doses, has psychedelic properties that can be effective in treating treatment-resistant depression and other mood disorders in an off-label capacity. In fact, there’s already an FDA-approved ketamine component drug, esketamine (a/k/a Spravato), with an approved indication for treatment-resistant depression.
What is Ketamine-Assisted Therapy?
Ketamine-assisted therapy entails the administration of low doses of ketamine (usually intravenously, orally, or intranasally) in concert with psychotherapy sessions in order to treat mental health disorders like treatment resistant depression, PTSD, and anxiety (among others).
The Psychedelic Legal Movement and Off-Label Treatment Challenges
The uptick in ketamine clinics and ketamine-assisted therapy is likely due to the upswell of the psychedelic legal movement in various states and cities. In addition, the FDA is currently allowing clinical trials to proceed on nearly dozens of psychedelic drugs for a variety of mood disorders and mental health issues. In turn, healthcare providers are increasingly interested in prescribing ketamine off-label to patients in need.
Off-label treatment and exploration are not without their complications. The main exceptions to off-label use are if the use violates (i) medical professional ethical guidelines and/or conduct standards or (ii) applicable safety regulations. And providers that prescribe “compounded ketamine nasal spray” have officially been warned by the FDA that such products carry risks that may violate applicable FDA safety regulations. The interesting twist with this warning is that the FDA is focused on the use of these products by patients at home with little to no medical monitoring during treatment (which was/is a hugely popular telemedicine treatment model during and after the COVID pandemic).
In February 2022, the FDA issued a warning about “compounded ketamine nasal spray”. On October 10, 2023, the FDA issued another warning to both patients and healthcare providers that “compounded ketamine products” (including oral formulations) carry significant risks for the treatment of a variety of psychiatric disorders. In the warning, the FDA makes clear that ketamine is not an FDA-approved treatment for any psychiatric disorder despite marketing efforts that position ketamine as a panacea for psychiatric disorders. The FDA also reminds us that compounded drugs are not FDA-approved anyway, which means the FDA hasn’t in any way evaluated their safety, effectiveness, or quality prior to their marketing. Importantly, the FDA goes on to state that:
Use of compounded ketamine products without monitoring by a healthcare provider for sedation (sleepiness), dissociation (disconnection between a person’s thoughts, feelings, and sense of space, time, and self), and changes in vital signs (such as blood pressure and heart rate) may put patients at risk for serious adverse events.
Telemedicine, Compounded Ketamine Products, and FDA Warnings
There are definitely ketamine therapy provider models out there that still entail some combination of telemedicine and self-administration of compounded ketamine products (like lozenges, for instance) at the patient’s home while being monitored remotely by a lay person (sometimes called a “tripsitter”) who is not a qualified healthcare provider (or there’s no monitoring at all in some cases). Despite the DEA’s COVID-induced loosening of the Ryan Haight Online Pharmacy Consumer Protection Act regarding the prescribing of controlled substances via the internet, this kind of medical delivery model is legally precarious at best and now completely cuts against the FDA’s October warning.
Reading between the lines of this most recent warning, if you’re a ketamine provider, clinic, management/medical services organization supporting providers, or telemedicine platform, here’s what to consider if you don’t want to draw the ire of the FDA:
- Patients should know that ketamine is not an FDA-approved drug for any psychiatric disorder;
- Do not misrepresent the alleged benefits of ketamine to patients (meaning, mind your marketing in line with this warning, especially when it comes to compounded ketamine products);
- Either don’t prescribe compounded ketamine products or, if you do, ensure that the patient knows the exact risks associated with such products, including the potential for all adverse events and effects;
- Avoid “at-home treatment and no monitoring” models altogether—the FDA has made clear that those scenarios put patients at increased risk for abuse, misuse, and psychiatric events; and
- If your treatment model entails at-home treatments, not only ensure that patients are monitored by qualified healthcare providers (ideally on-site at the patient’s home rather than remotely via telemedicine), but that patients know the specific risks of at-home treatments versus a clinical setting.
I doubt that this is the last ketamine off-label related warning we’ll see from the FDA. With the increase in ketamine-assisted therapy, we’re bound to see other safety guidelines be established as well as litigation surrounding the issues of malpractice and general negligence when it comes to dosing, monitoring, and effectiveness of treatment. In turn, compliance plans and protocols have never been more important for ketamine therapy providers of all kinds.
Husch Blackwell provides its emerging therapies and healthcare clients with a full suite of legal services that bear upon the development of new products and therapies. Contact Hilary Bricken or your Husch Blackwell attorney if you have any questions about navigating the evolving regulatory landscape of ketamine off-label use.