The FDA & The Future of Psych*delic Healing

“Unlike the rote memorization or algorithmic repetition found in medical or flight training, the first core competency of psychedelic facilitation is empathetic, abiding presence. This means embracing humility, letting go of judgment, fostering openness, and vulnerability, and deep attunement to the (individual’s) feelings. It means embodying a stable, grounded way of being. You become an anchor, as well as a source of compassion. And even, love.” Joshua Potocko, MD, MPH

Over 80+ diverse speakers came together earlier this week to offer their two-minutes of counsel, advice and reflections to the FDA on bringing psychedelic therapies into our modern healing systems & frameworks. The speakers & stakeholders spanned the spectrum of the psychedelic field: from clinicians and researchers, to investors and entrepreneurs, community organizers and non-profit founders, to individuals who have had their own profound healing through psychedelics.

Listening to the four-hour hearing, one of the strongest themes was the recommendation that the FDA not treat psychedelic therapy as simply another molecule… that the “human” elements of psychedelic therapy - preparation, guidance, support, care, witnessing, integration, setting, environment - are a profoundly important and vital part of the experience. They emphasized how different psychedelic medicines are from more familiar pharmaceuticals, and that psychedelic frameworks must include the full arc of the relational, subjective human experience versus simply deliver a singular, standardized dose.

Nurses and pharmacists shared how they are poised to play a pivotal role in the growing psychedelic field, while veterans shared their own powerful testimonies - both their gratitude for the ability to access this healing - while also lamenting how many other veterans have been unable to benefit due to the restrictions and lack of access in the United States. Sandy Samberg echoed this when she shared case studies of individuals who had sought out psychedelic care, only to be met by clinicians who weren’t aware, equipped or trained in the care that may have helped them.

Other speakers like Emily Brewer invited the FDA to consider psychedelic applications beyond exclusively mental health conditions, while former USAF JAG Lynn Watkins provided a first-hand testimonial of how psychedelics enabled her to heal debilitating chronic pain and get her life back. Oregon facilitators voiced support for pathways and access outside the medical model’s limiting framing - diagnoses, conditions, insurance coverage and endless referrals - noting that clients seek psychedelic exploration within their current state regulated model for expansive intentions outside of diagnosed mental health conditions. And Heather Kuiper held out the idea that psychedelic therapy is not only for the healing of addiction, it can actually be preventative therapy - healing a person before the symptoms of trauma & addiction ever present.

Many speakers across the diverse field spoke to the need for training standards and competencies, many emphasizing the need for experiential training, mentorship, and extensive personal experience beyond academic and didactic education. They also addressed accessibility, costs, group models, client safety, ethics, therapeutic touch and holding space for psychedelic use outside of strictly medical, clinical and insurance models.

Christine Caldwell - founder of End of Life Psychedelic Care - brought forward Right to Try models for those facing terminal and life-threatening illnesses, and many of the established ketamine clinic providers shared - repeatedly - that, as Nikita Tsimmer said, “The care surrounding matters just as much as the treatment itself.”

Mark Nicolas - who has been working in the field since 2008 - urged the FDA to not necessarily think something entirely new needs to be created… that there are established community models that we can look to, borrow from and model off, and I could not agree with this more. I personally believe that consulting the longtime underground facilitators and community-based, grass-roots organizers who have been doing this work safely, ethically and effectively for decades hold a wealth of knowledge and valuable best practices.

Christian Reed - a former Green Beret - urged the committee to consider access and cautioned that clinic-only models will leave many rural communities behind, while Melissa Lavasani called out the disparity and lack of women being included in psychedelic research.

Aside from a psychiatrist’s insistence that they must be ‘at the helm,' a doctor who wants to be in charge of accrediting others, and more than a few people claiming to be THE FIRST so-and-so - the room was astonishingly free of ego, inclusive, intentional, interested in diverse perspectives, reflective and thoughtful. An interconnected global mycelium - every voice included. This is our field at its best.

“We’ve waited fifty years to have access to psychedelic medicines, and our patients deserve to have to safe, legal and effective treatments,” Raymond Turpin of The Pearl Institute reflected.

After listening to voice after voice stand & speak, it certainly seems like 2027 might be the year we turn the page and fate presents us with a beautiful opportunity to do things differently.

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Listening to the heart and steady dedication of so many of the speakers was such a beautiful reminder of how many incredible people there are across the diverse landscape of this field. While everyone is immensely different in approach, background and experience, the uniting force is the real healing & transformation we see every day working with our clients, patients and participants.

I see it, too, in the facilitators and future guides coming to professional microdosing facilitation & practice - across the now four cohorts of our microdosing training, I see the same heart, dedication, intentionality, openness and readiness to embrace a different way of approaching our healing & growth. And embodying a diversity that only makes the field stronger and more resilient, just like nature.

When I asked my own guide recently how she thinks medicine work should be held in society, she answered this: at the age of nineteen, one would begin their preparation with the elements - their healing supported with light and sound, earth and water - and learning the language of the natural world. They would begin a decade-long mystery school of learning, healing, modalities, coming to understand themselves, and discovering their gifts… before any sacred medicine was introduced.

Around 29 the individual would enter an initiation - taken under the mentorship, modeling and direction of elders - where they would begin an evolving series of mentorship, apprenticeship, growth and service... including intentional relationship with the medicine, thoughtfully and sparingly held alongside the birth chart and gifts, dharma and design of the individual. The opportunity would be held out to learn different approaches; different ways would be embraced, different perspectives would be offered… all in service of honing & refining one’s path and unique medicine.

Only after the crossing of eldership - age 50 and beyond - could one hold & serve medicine, and - while anyone could receive the healing & blessing of the medicine - only initiated, elder individuals with decades of experience could sit beside a journeyer.

This vision felt old, imprinted across time, and true, and I continue to sit with it and wonder how it may be translated into modern life — I hope we can infuse some of these ‘old ways’ into our ‘new ways’ as we conceive modern-day medicine practice, and continue to support each other in creating new human-centered models for healing.