Statement on FDA’s Failure to Approve MDMA-Assisted Therapy for Post-Traumatic Stress

HAF released the following statement to the national media following the Federal Drug Administration (FDA) decided to require additional, time-consuming clinical trials for treatment of Post-Traumatic Stress Disorder with MDMA-assisted psychotherapy:

“With this unconscionable decision, it’s now clear that the path for desperately needed access to psychedelic-assisted therapies will not run through Washington, D.C. With an undeniable mental health crisis in this country, we can’t afford to wait for an ineffective federal bureaucracy to catch up. States must take the lead to bring people the care they need and deserve.

“States like Oregon and Colorado are paving the way for effective, thoughtful psychedelic-assisted healing programs that are designed for safety and accountability. 

“The Oregon psilocybin therapy program, which opened a year ago, has already served nearly 5,000 people. Each of them has gone through a thoughtful four-step process of assessment, preparation, administration and post-administration integration under the supervision of a trained facilitator, with administration of psilocybin happening inside a licensed service center. Colorado will stand up a similar program early next year. With a focus on regulated therapeutic access, neither program allows for any form of retail sales or dispensaries.

“The FDA has essentially told the 13 million Americans suffering from PTSD that their healing is not a priority, despite research from a multitude of clinical trials and leading academic institutions showing the incredible promise of psychedelic-assisted therapy. 

“The FDA’s failure is our call to action. By throwing our efforts behind building and expanding thoughtful state-based programs, we can ensure that those who are suffering have a new opportunity to heal.”