Expert Insights on FDA’s Recent PTSD Treatment Meeting

Dear MAPS community and supporters,

We’re excited to share insights from the U.S. Food and Drug Administration (FDA) hybrid public meeting, Advancing Treatments for Post-Traumatic Stress Disorder (PTSD). This important event brought together numerous federal agencies to discuss the urgent need for advancing innovative PTSD therapies. The meeting included a stakeholder comment period that included several participants in MDMA-assisted therapy trials who shared their stories of healing from PTSD. 

Following the meeting, the Multidisciplinary Association for Psychedelic Studies (MAPS) hosted a press briefing, which was attended by more than a dozen top-tier journalists and featured key thought leaders, including:

• Bessel van der Kolk, M.D., Psychiatrist, author of The Body Keeps the Score, and pioneer in trauma research.
• Darron Smith, Ph.D., PA-C, DFAAPA, U.S. Army Veteran, physician associate, and researcher focused on neurofeedback and psychedelic therapies.
• Dave Rabin M.D., Ph.D., board-certified psychiatrist, neuroscientist, entrepreneur, and inventor who has studied resilience and the impact of chronic stress on our lives for more than 15 years.
• Michael Mithoefer, M.D., former Senior Medical Director at MAPS PBC and pioneering principal investigator in MDMA-assisted therapy research.
• Betty Aldworth, Director of Communications & Post-Prohibition Strategy for MAPS

The FDA and Reagan-Udall Foundation meeting on PTSD highlights the urgency of finding, testing, and accelerating approval of novel drug-therapy combinations for this debilitating health condition. More than that, it illustrated the growing public interest in psychedelic-assisted therapies, with nearly every speaker discussing their potential in a meeting that wasn’t specifically about psychedelics. Eighty members of Congress, the Veterans Affairs Administration, trauma experts, patient advocates, and 14 of 23 stakeholders who gave oral testimony agree that the existing evidence base for psychedelic-assisted therapies merits widespread, and growing, support. It’s time to close the 25-year gap on new pharmacotherapies for the treatment of PTSD by approving this most promising treatment for PTSD and bringing psychedelic-assisted therapies into the healthcare system.

Betty Aldworth, MAPS Director of Communications & Post-Prohibition Strategy

Below, keep reading for key takeaways from the panelists, and if you’re able, please make a gift today to support MAPS’ public education work. 

SELECT COMMENTS FROM PANELISTS:

• Betty Aldworth
  • “The delay in FDA approval of MDMA-assisted therapy has been heartbreaking, not just for MAPS, but for the thousands of people still suffering from PTSD who have reached out to us, desperate for effective treatment. Despite support from 80 members of Congress, Veterans groups, and trauma experts, the FDA continues to delay. Many people are using psychedelics in unregulated settings because they see them as their last chance to heal.”
  • “States like Colorado and Oregon have already implemented regulated psychedelic treatment models, and we’re hopeful Massachusetts will follow suit. MAPS is committed to working with people and communities across the U.S. and globally to ensure safe access to these treatments. Because the voters in those states, the people, have decided it is time to move beyond the FDA process that is currently failing many patients living with PTSD. MAPS is as committed as ever to working with people and communities across the U.S. and globally to advance safe, legal access to these treatments. We are going to be putting a lot of our energies into the kinds of efforts that are going to provide access, regardless of what the FDA requires because the reality today is that many people are accessing these treatments.”
• Dr. Michael Mithoefer
  • “I think people in the beginning tended to overstate the effectiveness of existing therapies, though they all admitted we need more therapy. The reason I started doing research was because treatments for PTSD were so woefully lacking. In the MAPS Phase 3 data, about two-thirds of people lost the diagnosis of PTSD. If these treatments can get approved, it would be a huge leap forward.”
  • “The FDA process doesn’t require demonstrating superiority to existing treatments. It requires superiority to placebo and safety. Yes, it would be good to do studies to compare with other treatments, but drug approval normally does not wait for that.”
• Dr. Bessel van der Kolk
  • “MDMA helps people revisit dark places and say, ‘This happened, but it wasn’t my fault.’ Prozac doesn’t cause that. The most important finding is not how you relate to your trauma, but how you relate to yourself. That’s the marvel of these psychedelic agents: they allow people to see their trauma with fresh eyes and move on with a new perspective.”
  • “To go through that stuff by yourself—that’s why the psychotherapy piece is so important. All of our subjects in the study said they could never have gone to these very dark places unless they had people there to hold them because so much miserable stuff came up. But finally, under these conditions, you’re able to go there and say, “Yes, it happened, but it is over.”
• Dr. Darron Smith
  • “The DSM-5 diagnostic criteria are highly suspect, especially when it comes to racial trauma. Racial trauma is an accumulation of experiences over a lifetime. We need more holistic tools to evaluate healing and transformation, particularly for communities of color, as the current metrics often exclude them.”
• Dr. Dave Rabin
  • “MDMA therapy is revolutionary because it enhances neuroplasticity—the brain’s ability to rewire and learn new things. Safety is critical for this process, and MDMA allows people to feel safe enough to revisit traumatic experiences. It fosters an environment where healing can happen quickly, something traditional psychotherapy struggles to achieve.”
  • “MDMA therapy is one of the most important medical discoveries in mental health, akin to the discovery of antibiotics. It’s a revolutionary moment, and I think, eventually, this will come through. There’s always resistance to new ideas, but the benefits of this treatment will become clear.”

Next Steps for MAPS

• Educating Healthcare Providers and Policymakers: We are intensifying efforts to inform professionals about the potential benefits of psychedelic-assisted therapies and the need for their responsible use.
• Working with Regulatory Bodies: MAPS remains dedicated to collaborating with regulatory agencies to ensure safe and effective implementation of these treatments for those who need them most.

How You Can Help

• Support Our Work: Your continued support is critical to driving our research forward. Consider making a donation to help us advance this groundbreaking research: maps.org/donate
• Stay Informed: Follow us on social media and subscribe to our newsletter for updates on our progress and upcoming events.

Thank you for being an essential part of this historic movement. Together, we are reshaping mental health treatment and bringing hope to millions suffering from PTSD.