MAPS Provides Additional Response to FDA Regarding Clinical Hold for the Open-Label, Multi-Site Research Study of the Safety and Psychological Effects of Manualized MDMA-Assisted Therapy in Healthy Volunteer Therapists (Study MT2)

MAPS received no response from the U.S. Food and Drug Administration (FDA) to the reconsideration request submitted on October 11, 2020. 

On December 31, 2019, MAPS provided an additional response with newly generated data to address the hold issues. This included safety data from ongoing clinical studies, self-report survey results from participants in the prior healthy volunteer therapist study, Study MT1, showing that the group overwhelmingly experienced benefits from their participation.

This submission also included letters written by leading clinicians and researchers in support of MAPS’ argument that there is no evidence to suggest that requiring clinical investigators to hold a doctoral degree would result in improved safety or efficacy in Study MT2.

These 22 letters critiquing the FDA’s requirement that the lead facilitator be an M.D., Ph.D., or equivalent supported MAPS proposal to require the lead facilitator to have a license to practice psychotherapy, rather than arbitrarily limiting it to practitioners with doctoral degrees. In this way, with the support of colleagues, we seek to educate FDA rather than accept proposed requirements that are not supported by evidence.