After two years of negotiations, MAPS won an appeal with the FDA to pave the way for future therapists-in-training to experience an MDMA dosing session first-hand.
MAPS has always held the position that experiencing effects of MDMA is an integral part of understanding how MDMA-Assisted Therapy works, but the FDA had concerns about allowing healthy volunteers to use MDMA.
On May 10, 2021, MAPS won the FDA appeal, which opens the possibility for future therapists-in-training to experience a dosing session.
This is an unprecedented development that will essentially allow MDMA therapy to be studied in healthy volunteers with no necessity for any diagnosis*. In this case, these volunteers will be therapists, but in the future this might open the door for MDMA Therapy to be approved for anyone, in contexts such as personal development or couples therapy. But of course, let’s not get carried away.
The same appeal was also concerned with two further key issues related to the future of MDMA Therapy. First, initially the FDA required that the lead therapist in this study had to have an MD or PhD level education. This requirement was lifted with the current appeal, allowing MA level therapists to lead the therapy. Secondly, the FDA initially required the prescribing physician to be on-site during the long dosing session. This requirement was modified to only requiring the prescribing physician to be on-call.
The practical effect of this triple win by MAPS will likely mean easier future access to MDMA Therapy training and MDMA Therapy itself.
Once again, MAPS continues to focus on bringing MDMA-Assisted Therapy to as many people in need as quickly as possible, while at the same time maintaining solid safety and effectiveness standards.
At this point, it is unclear whether Health Canada will allow the same provisions for Canadian therapists training with MAPS.
* To date, FDA approval of MDMA Therapy is solely focused on PTSD.