Inside the Psychedelic Policy Shift: Four Takeaways From Washington, DC

The psychedelic medicine field just had its most consequential week in decades. On April 18, 2026, President Trump signed an executive order titled Accelerating Medical Treatments for Serious Mental Illness, directing federal agencies to fast-track research and potential FDA approval for psychedelic compounds. Our founder, Jay Godfrey, was in Washington, DC for a gathering of leaders in psychedelic medicine — clinicians, researchers, advocates, and policymakers — and came back with a clear message: the energy in the room was unlike anything he has experienced in this field.

But energy alone does not help people heal. What matters is what happens next. Below, we share four observations from those conversations in DC — and what they may mean for people who are looking for relief now.

1. The executive order is real momentum, not just symbolism

The conversations in Washington made one thing clear: this executive order carries weight beyond the headline. The order directs the FDA to provide National Priority Vouchers to psychedelic compounds with Breakthrough Therapy designation, compressing review timelines from the typical 6–12 months to as little as 1–2 months. It allocates $50 million through HHS for federal-state collaboration on psychedelic research. And it instructs the FDA and DEA to establish a pathway for patients to access psychedelic drugs, including ibogaine, under the Right to Try Act.

Within days of the signing, FDA Commissioner Marty Makary issued three National Priority Vouchers: one to Compass Pathways for psilocybin (COMP360) for treatment-resistant depression (TRD), one to Usona Institute for psilocybin for major depressive disorder, and one to Transcend Therapeutics for methylone (TSND-201) for PTSD.

People in the room kept saying the same thing: this is the clearest federal signal we have ever received that psychedelic-assisted therapy is being taken seriously as medicine.

2. Psilocybin may be approved soon — but commercialization is the hard part

The psilocybin conversation in DC was not about if it would be approved. It was about how it would actually work once approved.

Compass Pathways’ COMP360 is the most advanced candidate. The company has enrolled more than 1,000 participants across two Phase 3 clinical trials and received FDA approval for a rolling NDA submission. With a National Priority Voucher now in hand, the review period after full submission could be as short as 1–2 months. An FDA-approved psilocybin therapy could arrive as early as 2027.

But approval is just the starting line. The questions people were wrestling with in DC were practical:

• Who administers the treatment? Psilocybin-assisted therapy may involve sessions lasting six to eight hours, with trained therapist support throughout. Where do the therapists come from? How are they credentialed?
• Who pays for it? The executive order does not address insurance coverage, clinician training, or the healthcare infrastructure needed to deliver psychedelic therapy at scale.
• Where does it happen? Psychedelic-assisted therapy requires clinical settings with monitoring, privacy, and trained staff — not a standard 15-minute medication check.

These are not theoretical concerns. They are the exact barriers that slowed Spravato (esketamine — a nasal spray derived from ketamine, approved for treatment-resistant depression) when it first came to market. And every company entering this space is studying that story closely.

3. Everyone is trying to learn from Spravato’s playbook

If one phrase captured the commercialization conversations in DC, it was: How do we replicate what Spravato figured out?

Spravato — the FDA-approved esketamine nasal spray made by Johnson & Johnson — is the closest thing the field has to a commercial blueprint for psychedelic-adjacent therapy. It is projected to sell $2 billion this year, administered across more than 7,300 certified treatment sites nationwide. But that success did not come easily.

When Spravato first launched in 2019, it faced steep reimbursement challenges because providers lacked the billing codes to be compensated by insurers for the administration and monitoring process. There were only a few hundred certified centers. It took J&J years to build the infrastructure — the Risk Evaluation and Mitigation Strategy (REMS) program, the observation protocols, the insurance pathways — that now supports the drug at scale.

Every company working toward psychedelic therapy approval is paying attention to those lessons. The Compass Pathways team has said publicly that they expect any center currently delivering Spravato will be able to deliver COMP360. That existing infrastructure may shorten the ramp-up period. But psilocybin therapy requires longer sessions, more intensive therapist involvement, and different protocols. The infrastructure question is far from solved.

For us at Nushama, this conversation is personal. We already operate within the Spravato REMS framework, administer IV ketamine under medical supervision, and provide the kind of preparation and integration support that psychedelic-assisted therapy demands. We have spent years building exactly what the field now says it needs. When new treatments receive approval, clinics with established psychedelic-informed care models will be positioned to deliver them responsibly.

4. Ibogaine for veterans has powerful advocates — and real science behind it

The ibogaine conversation was the most emotionally charged in DC. Veterans, active-duty service members, and military families have been among the loudest voices pushing for expanded psychedelic access, and the executive order responds directly to that advocacy.

The order specifically names ibogaine and directs the FDA and DEA to establish a patient access pathway under the Right to Try Act. At the White House signing ceremony, former Navy SEAL Marcus Capone — who credits ibogaine with helping him recover from PTSD caused by blast-related traumatic brain injury (TBI) — was in the room applauding the president’s decision.

The research backs up the advocacy. A 2024 Stanford Medicine study published in Nature Medicine followed 30 special operations veterans with TBI and repeated blast exposure who received magnesium-ibogaine therapy at a clinic in Mexico. The results showed significant improvements in functioning, PTSD symptoms, depression, and anxiety — both immediately and one month after treatment. A follow-up analysis published in Nature Mental Health in 2025 examined the neural mechanisms behind those improvements.

Ibogaine is not without risk. It carries documented cardiac concerns, which is why the Stanford protocol combined it with magnesium and included medical monitoring. It remains a Schedule I substance in the United States, and the first U.S. clinical trials are only now getting underway. But the federal momentum — $50 million in research funding, a Right to Try pathway, and strong bipartisan support — suggests ibogaine may emerge as a meaningful option for veterans with treatment-resistant conditions who have not responded to existing therapies.

It is worth noting that ibogaine, even with regulatory progress, may not be widely accessible for some time. The conversations in DC acknowledged this openly: it could initially serve as a specialized, last-resort option for veterans and others with severe, treatment-resistant conditions. Broader availability will depend on clinical trial results, safety data, and the infrastructure to deliver it responsibly.

What this means for people seeking help today

The executive order is promising. The field is energized. New treatments may be on the horizon.

But right now, today, people are struggling with treatment-resistant depression, PTSD, anxiety, and other conditions that have not responded to standard therapies. And they should not have to wait for a regulatory timeline to find relief.

Ketamine-assisted therapy is available now. It is legal, well-studied, and does not require rescheduling or clinical trial enrollment. At Nushama, every member receives a thorough medical screening and psychiatric intake before treatment begins. Sessions are medically supervised, individually titrated, and supported by preparation and integration — the same model the psychedelic field is now building toward for psilocybin and ibogaine.

If you or someone you care about is living with a treatment-resistant condition and wondering what options are available, you do not have to wait for the next wave. Book a consultation with our care team to find out whether ketamine-assisted therapy may be a good fit.

Frequently asked questions

What did the April 2026 psychedelic executive order do?

The executive order, signed on April 18, 2026, directed the FDA to fast-track review of psychedelic compounds, allocated $50 million for federal-state psychedelic research collaboration, and instructed the FDA and DEA to create a patient access pathway for ibogaine under the Right to Try Act. It also led to the FDA issuing National Priority Vouchers to three psychedelic therapy programs within days of the signing.

When will psilocybin therapy be available in the United States?

Compass Pathways’ COMP360 is the most advanced psilocybin candidate. The company has initiated a rolling NDA submission and received a National Priority Voucher that could compress the FDA review to 1–2 months after filing. Analysts suggest approval could come as early as 2027, though commercialization — including clinician training, insurance coverage, and treatment infrastructure — will take additional time.

Is ibogaine legal in the U.S.?

Ibogaine is currently a Schedule I substance, which means it is not legal for medical use in the United States outside of approved clinical trials. The executive order directs the DEA and FDA to establish a Right to Try access pathway, and the first U.S.-based clinical trials are now moving forward. However, it may be some time before ibogaine is broadly available.

How is ketamine therapy different from psilocybin or ibogaine?

Ketamine is a Schedule III substance that is already legal and available by prescription. It does not require rescheduling or clinical trial enrollment. Ketamine works through NMDA receptor pathways rather than serotonin pathways, which means most people do not need to taper off antidepressants before starting treatment. Psilocybin and ibogaine remain under federal restrictions and are not yet available for routine clinical use.

Can I get ketamine therapy now?

Yes. Ketamine-assisted therapy is available at Nushama’s centers in New York City. Treatment begins with a comprehensive medical screening and psychiatric intake, followed by medically supervised sessions with preparation and integration support. Book a consultation to learn whether it may be a good fit for your needs.