How will MDMA be rescheduled in the future? You may be disappointed

What does the future hold for MDMA? This is part 2 of a 4-part series on the future of MDMA. The series explores the Multidisciplinary Association for Psychedelic Studies’ (MAPS) ongoing FDA phase 3 clinical trials, rescheduling, health insurance, and the FDA program known as expanded access

What does MDMA rescheduling mean for the recreational user? If you are under the impression that MDMA is on its way to being rescheduled, across the board, you may be disappointed. Assuming that the Multidisciplinary Association for Psychedelic Studies (MAPS) can prove the medical safety and efficacy of MDMA-assisted psychotherapy for PTSD in Phase 3 trials, the Food and Drug Administration (FDA) will be required to approve MAPS’ specific type of MDMA for prescription.

The MDMA being used for Phase 3 trials is a specific Good Manufacturing Practice (GMP) MDMA.  What “GMP” means is that the product has been created with practices approved by the FDA.

In MAPS’ case, “GMP MDMA is a highly purified drug in a specific delivery system (currently capsules with certain amounts of MDMA and other inactive ingredients like sugar to make all the capsules weigh the same). General MDMA is the same drug but without a specific delivery system,” according to Rick Doblin, the Executive Director of MAPS.

GMP drugs are produced in approved facilities that can produce large commercial amounts. Doblin added that these facilities have “lots of paperwork, stability studies, analytical methods validation, and documented and standardized production processes.”

MAPS’ MDMA is manufactured by Onyx Pharmaceuticals and encapsulated by Sharp Packaging Services. Assuming MDMA is rescheduled, only this GMP MDMA from MAPS will be available for purchase by prescription.

MDMA is currently a Schedule 1 drug. MAPS is trying to get their MDMA rescheduled to Schedule 3. But Doblin said that it is entirely possible that the Drug Enforcement Agency (DEA) — which would ultimately be responsible for the drug’s rescheduling, after trials are done through the FDA — would only be willing to move it to Schedule 2.

Doblin speculated that if the DEA will only reschedule GMP MDMA to Schedule 2, it is more likely that general MDMA will also be rescheduled to Schedule 2 in the future. But, if the DEA is willing to reschedule GMP MDMA to Schedule 3, Doblin isn’t sure they would be willing to reschedule general MDMA to 3.

This is because “Schedule 3 is for drugs that have less than a high potential for abuse,” Doblin said. The DEA might not be comfortable saying that there is “less than high potential for abuse” of certain ways of ingesting MDMA — other than those meeting GMP standards.

This would make MDMA one of several drugs listed in multiple schedules. The drug GHB, for example, is technically a Schedule 1 drug. But, If GHB is used in sodium oxybate under an Investigational New Drug (IND) or New Drug Application (NDA) from the FDA, GHB is considered a Schedule 3 substance with Schedule 1 trafficking penalties.

The penalties for MDMA will not change on their own, regardless of rescheduling. The recommended penalties for sale and/or possession of general MDMA are set by the US Sentencing Commission. Doblin has testified before them in both 2001 and 2017 to no avail.

“There is no way to tell for sure what will happen if MAPS succeeds, regarding the rescheduling of general MDMA,” Doblin said. “From a strategic perspective, if we do succeed, drug policy reform advocates would probably reduce more people’s’ time in prison/jail by focusing on getting the US Sentencing Commission to reduce the sentencing guidelines than by trying to work with DEA/Congress on rescheduling general MDMA.”  

 

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Jag Davies, the Director of Communications Strategy for the Drug Policy Alliance, said that a lot of people are starting to realize that medicalizing MDMA won’t automatically lead to any reduction in criminal penalties for people who use it outside of a medically-supervised, government-approved facility.

“There are a lot of drugs that are approved for medical uses, yet still harshly criminalized,” Davies said. “90 percent of drug enforcement happens at the local and state level, so when it comes to reducing the criminalization of MDMA and psychedelics, that’s where people can have the most impact — working for drug policy reforms locally, such as de-felonizing and decriminalizing drug possession.”

The future of psychedelics within our legal system is unclear, but there is a level of discomfort among some people when the discussion turns to broader legalization of psychedelics.

“Personally, I believe full legalization of all psychedelics is irresponsible,” said David Nichols, the president of the Heffter Research Institute, a non-profit organization conducting research into psilocybin-assisted therapy. “They can cause psychological harm when used improperly and are far more dangerous than cannabis, which has often been used as a model to argue for psychedelic legalization efforts.”

Heffter Research Institute has taken no public position pro or con towards the recreational use of psychedelics, according to Nichols. But, they do recommend use of psychedelics only in controlled circumstances with clinical supervision due to the potential for psychological harm.

While Nichols doesn’t support reform efforts that would mirror the over-the-counter-style sale of cannabis, he is in support of the decriminalization of psychedelics. He does not believe anyone should be made a criminal for use or possession of a psychedelic substance, going as far as to say that people in prison for using psychedelics should be released immediately.

“I would still penalize manufacturers and traffickers of psychedelics, although I think penalties should be rethought; they are probably much too harsh in most states,” Nichols said.

Nichols thinks that if drugs like MDMA and psilocybin are rescheduled, it will be very hard for authorities to maintain harsh penalties for their use.

“Right now they are considered to be dangerous drugs,” Nichols said. “But, once they have proven efficacy and safety I believe there will be a push to reduce penalties for use.”

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