Cannabis is legal and regulated in most U.S. states. Oregon legalized and will soon regulate psilocybin. Cities around the country decriminalized (and more are decriminalizing) a host of other psychedelics. Ketamine clinics are popping up around the county. Next up is MDMA (referred to in some forms as “ecstasy”). Today, we’re going to talk about how MDMA will be regulated.
In 2019, when Denver opened up the psychedelics floodgates by legalizing psilocybin, it was totally unclear what the future of regulated psychedelics will look like. With a few exceptions, that’s still the case. It’s entirely plausible that they go the route of cannabis (as is happening in Oregon) or some new route (as is happening with local grassroots decrim efforts). But the point is we really have no idea how that will all shake out in the long run.
That’s not the case at all with MDMA, and we can predict its future with a much greater degree of certainty. The reason for this is because MDMA is winding its way through the U.S. Food and Drug Administration’s (FDA) process for Investigational New Drugs (IND). For a really good and succicnt summary of that process, you should read my colleague, Ethan Minkin’s, summary here.
The entity behind MDMA’s push through the IND process is the Multidisciplinary Association for Psychedelic Studies (MAPS). While a few years ago, the concept of legal MDMA may have seemed crazy to some, MAPS has done a masterful job cutting through the red tape. Earlier this year, we wrote about how MAPS was progressing through the Phase III study process and was targeting FDA approval in 2022 and commercialization in 2023 — if these targets are met, they would be on par with Oregon’s legal psilocybin licensing program.
With that all in mind, let’s return to what the regulated market will look like. Assuming MDMA is approved to treat certain conditions — and in our view, this is a “when”, not an “if” — it will be another regulated drug that can be administered by physicians in certain conditions. It will, to be sure, be subject to greater degrees of regulation than, say, ibuprofen, but you get the picture.
To see just what regulated MDMA will be like, we need to look no further than the regulated ketamine industry, something our lawyers have a lot of experience guiding clients on. Ketamine is a Schedule III narcotic and we did a really solid summary on how it is regulated here. In short, physicians prescribe and administer it for certain approved indications, need to register with the DEA, need to follow strict security and reporting protocols, and much more. Also, businesses intending to get into the industry need to be mindful of a massive amount of state and federal regulations, including things like restrictions on who can own a clinic and the relationships between physician-owned clinics and management services organizations.
In all likelihood, FDA-approved MDMA would be prescribed and administered in very similar conditions. And while MAPS is seeking approval for MDMA for post-traumatic stress disorder, physicians will almost certainly prescribe and administer it for off-label uses.
2023 may seem like a ways away at the moment, but it may not be long until there is an actual regulated market for MDMA. Healthcare laws are extremely complicated, but the upside is that unlike with cannabis and psychedelics, there’s a pretty clear roadmap for how things will likely shake out. We will continue to keep you all updated on MAPS’ progress, so please stay tuned.