On April 12th, Hilary Bricken moderated our firm’s webinar titled “Current Ketamine Regulations & The Future of Psychedelic Medicines.” In that webinar, Hilary, Griffen Thorne, and I (Ethan Minkin) discussed the new proposed telehealth regulations from the DEA regarding the Ryan Haight Act of 2008 that will undoubtedly affect the ketamine telehealth industry. We also discussed the FDA approval status of other psychedelic medicines. If you missed this webinar, the replay is just below. I’ll also cover some of the highlights further down, in this blog post.
DEA proposed regulations and their impact on ketamine telehealth
During the COVID pandemic, the Biden administration implemented emergency measures that impacted telehealth prescriptions. In particular, the emergency measures allowed healthcare practitioners to prescribe certain medications without an in-person consultation with a patient, which was required under the Ryan Haight Act. This allowed certain ketamine telehealth companies to flourish during the pandemic. However, the administration is allowing these emergency measures to lapse as of May 11, 2023.
Under the Ryan Haight Act, where controlled substances are prescribed by means of the Internet, the general requirement is that the prescribing healthcare provider must have conducted at least one in-person medical evaluation of the patient. U.S.C. § 829(e). The DEA has rulemaking authority under the Ryan Haight Act and proposed new regulations in February 2023 which would allow healthcare practitioners to continue to prescribe Schedule 3 to 5 drugs without first having an in-person consultation. However, under the proposed regulations, a healthcare provider must now have an in-person medical evaluation within 30-days of writing a new prescription. There are several exceptions under the proposed rules for this requirement. For example, if a provider has seen a patient in-person and then refers such patient to a behavioral healthcare provider, the behavioral healthcare provider would not need to then have another in-person evaluation.
While the proposed regulations are a step in the right direction, there are still concerns about accessibility for patients. If a patient must have an in-person consultation, that could limit telehealth services for people who live in rural areas. It is often the case that such individuals live far away from the closest behavioral healthcare provider. Requiring such patients to travel hundreds of miles to see a provider is not always tenable. Thus, the convenience of telehealth and the promised increase in accessibility to healthcare providers may be nothing more than an illusion for many people who live in rural areas of the US.
Status of other psychedelic medicines
Psilocybin and MDMA are both in Phase 3 FDA clinical trials. This is no small feat and is a first for any psychedelic medicines other than ketamine (if you consider ketamine a psychedelic in the first place). Phase 1 and 2 of FDA clinical trials involve a small number of patients and primarily test for safety, efficacy, dosing, and the like. By the time a drug has made it to Phase 3, the manufacturer has cleared several major hurdles for pre-market approval of a drug; although, making it to Phase 3 does not mean the drug will ultimately be approved by the FDA.
Both drugs have received a “breakthrough” designation by the FDA. According to the FDA, a breakthrough therapy designation is for a drug that treats a serious or life-threatening condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over available therapies. For example, such a designation would indicate that MDMA and psilocybin show more promise than traditional anti-depressants for the treatment of major depression.
While this is very exciting news, it must be tempered by the fact that the clinical trials are for one behavioral health indication only. For example, an indication could be a patient with PTSD, or a patient with major depression. Thus, if psilocybin and MDMA are approved by the FDA, each will be approved for one indication or disease state. However, there are many other clinical trials underway for both drugs. Anyone can check the overall status of a clinical trial, as well as which trials are ongoing, by visiting www.clincialtrials.gov. A search for either drug will result in many clinical trials.
One of the many advantages of having FDA approval is there is a higher likelihood that there may be insurance coverage available. Alternatively, as with many other drugs, healthcare providers will have the right and authority to prescribe such drugs for “off label” usage. Off label simply means the drug is being used for an indication for which it was not approved (the “label” of the drug provides information about what specific indication the drug may be used for).
During the webinar, we also discussed other topics, including the legal model that will be used for the new drugs when healthcare providers wish to venture with non-healthcare providers, and some of the risks involved when a non-behavioral healthcare provider treats behavioral health disorders with ketamine and other psychedelic drugs.
These are exciting times for telehealth providers as well as the psychedelic drug industry. There should be more psychedelic drugs entering our healthcare system over the next few years. These drugs hold a lot of promise for those who suffer from debilitating behavioral health disorders.
1. What were the discussed topics in the webinar?
The discussed topics in the webinar included the new proposed telehealth regulations from the DEA regarding the Ryan Haight Act, the FDA approval status of other psychedelic medicines, the legal model for the new drugs when venturing with non-healthcare providers, and the risks involved when non-behavioral healthcare providers treat behavioral health disorders with ketamine and other psychedelic drugs.
2. What are the proposed regulations by the DEA for ketamine telehealth?
The proposed regulations by the DEA would allow healthcare practitioners to continue to prescribe Schedule 3 to 5 drugs through telehealth without first having an in-person consultation. However, under the proposed regulations, a healthcare provider must now have an in-person medical evaluation within 30 days of writing a new prescription, with exceptions for referrals to behavioral healthcare providers.
3. What is the status of Psilocybin and MDMA in FDA clinical trials?
Both Psilocybin and MDMA are in Phase 3 FDA clinical trials, which is a significant milestone for psychedelic medicines. Phase 3 trials involve a larger number of patients and are focused on testing safety, efficacy, and dosing. However, approval for one behavioral health indication does not guarantee approval for other indications or disease states.
4. What are the advantages of FDA approval for psychedelic medicines?
FDA approval increases the likelihood of insurance coverage for the approved drug. Additionally, healthcare providers have the authority to prescribe drugs for off-label usage, meaning they can be used for indications for which they were not originally approved.