FDA EIR - Multidisciplinary Association for Psychedelic Studies - July 26, 2022

An FDA inspection of MAPS Public Benefit Corporation (MAPS PBC), a sponsor of MDMA-assisted psychotherapy clinical trials for Posttraumatic Stress Disorder, was conducted from July 11 to July 26, 2022. This high-priority inspection focused on Phase 2 and Phase 3 studies under Investigational New Drug (IND) 063384, assessing compliance with regulatory frameworks such as CPGM 7344.810 for sponsors. While no FDA Form 483 (Inspectional Observations) was issued, several verbal observations were discussed with management. Key issues included a significant number of unresolved queries in the electronic data capture (EDC) system for ongoing studies, incomplete review of therapist videotapes (e.g., only initial sessions for new therapists and limited retroactive review), acceptance of finished product without a Certificate of Analysis, and unsigned initial Serious Adverse Event (SAE) forms. The inspection also noted invalid certificates in Form 1572s, informed consent forms provided to subjects marked as 'templates,' incomplete survey data, and monitors failing to correct incomplete source data during verification. MAPS PBC management acknowledged these observations and verbalized understanding that these conditions, following further Agency review, could be deemed violations of the FD&C Act. Although no immediate enforcement actions were taken or required actions specified in writing, the firm committed to improving its process for maintaining and storing Corrective and Preventative Actions (CAPAs), indicating a need for enhanced adherence to clinical trial oversight and data integrity practices.