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Saturday, June 3, 2023

Here’s how MDMA is organized

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Cannabis is legal and regulated in most US states. Oregon legalized and soon regulated psilocybin. Cities across the country have decriminalized (and more decriminalized) a range of other narcotic drugs. Ketamine clinics are popping up all over the county. Next up is MDMA (referred to in some forms as “ecstasy”). Today, we will talk about how MDMA is regulated.

In 2019, when Denver opened the doors to the drug by legalizing psilocybin, it wasn’t entirely clear what the future of the regulated drug would look like. With a few exceptions, this is still the case. It’s perfectly reasonable for them to go the cannabis route (as happens in Oregon) or a new route (as happens with local grassroots efforts). But the point is, we really have no idea how that’s going to happen in the long run.

This is not at all the case with MDMA, and we can predict its future with a greater degree of certainty. The reason for this is that MDMA is making its way through the FDA’s Investigative New Drug (IND) process. For a good and successful summary of this process, you should read my colleague Ethan Menken’s summary Here.

The entity behind pushing MDMA through the IND process is the Multidisciplinary Association for Psychedelic Studies (MAPS). While a few years ago the concept of legal MDMA might have seemed crazy to some, MAPS did a masterful job of crossing the red tape. Earlier this year, we books on how MAPS is progressing through the Phase 3 study process and targeting FDA approval in 2022 and commercialization in 2023 — if those goals are met, it will be on par with Oregon’s legal psilocybin licensing program.

With all that in mind, let’s go back to what a regulated market would look like. Assuming MDMA is approved to treat certain conditions – and in our opinion, this is a “when” rather than an “if” – it would be another regulated drug that clinicians could use in certain circumstances. It’s definitely going to be much more regulated than, say, ibuprofen, but you get the picture.

To see what regulated MDMA would look 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 drug and we made a solid summary of how it is regulated Here. In short, doctors prescribe and administer it for some approved indications, need to be registered with the Drug Enforcement Administration, need to follow strict safety and reporting protocols, and much more. Also, companies intending to enter the industry must bear in mind a huge amount of state and federalism. systems, including such things as restrictions on who can own a clinic and the relationships between physician-owned clinics and management service organizations.

In all likelihood, FDA-approved MDMA will be prescribed and administered under very similar circumstances. And while MAPS is seeking approval for MDMA for PTSD, clinicians will almost certainly prescribe and administer it for used off-label.

2023 may seem a long way off right now, but it may not be long before there is a truly regulated market for MDMA. Healthcare laws are very complex, but the plus side is that unlike cannabis and drugs, there is a very clear roadmap for how things are likely to change. We’ll keep you updated on the progress of maps, so please stay tuned.

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