Navigating Complexity: Reflections on the FDA's MDMA-Assisted Therapy Decision and the Future of Psychedelic Medicine
VETS, Veterans Exploring Treatment Solutions, Inc
We provide resources, research, and advocacy to improve the quality of life for U.S. combat veterans and their families.
by Brad Burge
Director of Public Relations, Veterans Exploring Treatment Solutions (VETS)
Founder and CEO, Integration Communications
When I first read Rick Doblin 's doctoral dissertation back in 2009, I truly believed that he'd cracked the code—or at least the outlines of it. The strategy of defining MDMA as a medicine through the FDA drug development pathway seemed destined to work. But like any psychedelic experience, even when we can see the path to the finish line, we still need to walk it. And that road, as we're learning, is full of surprises.
The FDA’s recent decision to decline approval for MDMA-assisted therapy for PTSD, while disappointing, is not the end of the road. The agency’s request for further research serves as a reminder of the hurdles we still face in advancing psychedelic medicine through regulatory channels. Though not entirely unexpected, the decision remains deeply disheartening, especially for those who've been fighting this fight since the beginning. For those who stayed the course at MAPS and Lykos, holding onto the hope of being part of the team when the finish line was crossed, the setback must hit particularly hard. Whether or not the FDA has moved the goalposts, the reality is clear—the goal remains some distance away.
In my four years with VETS, Veterans Exploring Treatment Solutions, Inc (VETS), I’ve witnessed firsthand the profound courage it takes for veterans—trained to face external battles—to turn inward and seek healing for their deepest wounds. These are individuals who understand the power of vulnerability and the strength that comes from acknowledging their need for recovery. Veterans remain at the tip of the spear in this journey. Time and again, I’ve been amazed by their unwavering dedication, not just to their own healing, but to supporting their fellows, even while navigating their own personal struggles. Their commitment is truly inspiring.
The Current State of Psychedelic-Assisted Therapies
Despite the setbacks, there’s reason for optimism. The FDA’s request for more research isn’t a death knell for psychedelic medicine but rather an opportunity for refinement and growth. These challenges represent the growing pains of a nascent industry. Psychedelics have already made the leap from counterculture to mainstream, with an entire ecosystem of clinics, retreats, training organizations, pharmaceutical companies, technology developers, and nonprofits emerging. Now, the struggle lies in integration—in translating these substances and their associated experiences into frameworks that our technology-driven, drug-focused, capitalist culture can understand, engage with, and operationalize. We no longer need to convince people that psychedelics have benefits when used responsibly—that’s become common knowledge. The real challenge is in embedding these practices within systems that often prioritize different values, and in educating the public about their risks, as well.
As Thomas Insel MD astutely pointed out in his recent STAT article, the key innovation here isn't even the use of psychedelics. It's the combination of a drug plus therapy. This bundled approach, while potentially offering optimal care, presents a unique challenge for the FDA's traditional review process. The regulatory system, optimized for standalone drugs, isn't well-equipped to evaluate interventions that intimately link medication with psychotherapy.
Michel Foucault, an old academic fascination of mine, once argued that real change happens in the cracks between established systems—in the friction created when new ideas challenge old structures. The current intersection of psychedelics and modern medicine reflects this very tension. As I try to understand this moment and look ahead to the future of this field, I find myself returning to Foucault's insights. He taught us that social change emerges when we introduce something from one place and time—such as psychedelics—into a system rooted in another, like capitalism and modern medicine. What we're witnessing now, with increasing clarity, is the exact shape of these fault lines, the fractures that emerge in the integration of psychedelics and medicine.
These fault lines are numerous and complex. We're grappling with questions about the role of psychotherapy in psychedelic treatments, how to address accessibility issues in the gap between awareness and legal availability, how to ensure accountability and ethics in psychedelic therapy, and how to balance enthusiasm with responsible messaging. We're also facing the challenge of shifting from political to scientific hurdles, addressing concerns about safety and efficacy, and navigating the complex landscape of regulatory processes ill-suited for combination therapies.
Charting a Path Forward
Amidst these challenges, there's hope. State-level initiatives supporting research and harm reduction offer an opportunity for states to lead where federal agencies have hesitated. These initiatives could pave the way for more comprehensive research on therapy components and create legal pathways for responsible access. Plus, as we wait for the FDA to ultimately approve MDMA-assisted therapy (which I still believe it will), it’s already possible to access psychedelic therapies legally in other ways: ketamine is used off-label in the U.S. for a variety of mental health conditions, and ibogaine, ayahuasca, and psilocybin can all be accessed safely outside the U.S. in countries where they’re unregulated, as long as one does adequate research.
Largely thanks to the work of veterans—and so many others—the challenge is now more scientific than political. We have so much work to do, but the alliance has never been stronger. The cracks in our broken system have been exposed as never before—and, as the saying goes, that's where the light shines in.
As we move forward, we must advocate for regulatory evolution to accommodate psychedelic therapies. We need new processes that view psychological treatments as key facilitators rather than confounders of behavioral change. We must continue to support rigorous research, not just on the drugs themselves, but on the therapeutic processes that accompany them. Now is the time for scientists, doctors, advocates, and veterans and their families to come together, to pool our resources and knowledge, and to push for a more holistic understanding of mental health treatment.
We are witnessing the emergence of a new paradigm, one that demands persistence, and above all, a commitment to healing. Realizing this potential, however, will require more than just hope—it will take creativity and the courage to challenge established norms. We must skillfully navigate the complex intersections of science, spirituality, and regulatory frameworks, approaching these challenges with both rigor and openness. This journey calls for a mindset rooted in nonpartisanship and an unwavering focus on bridging cultural divides.
As we continue this journey, let's remember that we're not just pushing for the approval of a drug. We're advocating for a paradigm shift in how we approach mental health—one that recognizes the profound interconnectedness of mind, body, and spirit, and the potential for transformative healing that we all have within us.
The road ahead may be longer than we anticipated, but the destination remains as worthy of our efforts as ever. A light is shining through the cracks, illuminating a path forward. It's up to us to walk it, step by careful step, with wisdom, integrity, and an unwavering commitment to those who stand to benefit from these revolutionary therapies.
About Brad Burge
Brad Burge earned his B.A. in Communication and Psychology from Stanford University in 2005 and his M.A. in Communication from the University of California, San Diego in 2009. He was Director of Communications for the Multidisciplinary Association for Psychedelic Studies (MAPS) from 2011 to 2020, where he engaged daily with audiences around the world to enhance public knowledge about psychedelic research. He also directed the Psychedelic Science conferences in 2013 and 2017, which at the time were the largest psychedelic conferences in history. In 2020, Brad founded Integration Communications, a public relations firm dedicated to the psychedelic industry, which serves a wide range of clients in the growing field, and serves as Director of Public Relations for VETS. Brad is passionate about finding better ways for humans to work with the pharmaceutical and digital communications technologies of the 21st century. When he’s not plugged in, you’ll find him in the mountains, carrying a backpack, somewhere down a long trail.
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