Psilocybin Right to Try: Legal Status for Terminally Ill

Psychedelic Law & Policy

80% responded

In two landmark 2016 RCTs, roughly 80% of terminal cancer patients responded to psilocybin for depression and anxiety at 6 months. As of April 2026, none of those patients, or any terminally ill person in the US, can legally access psilocybin through the Right to Try Act.

Griffiths et al., J Psychopharmacol, 2016; Ross et al., J Psychopharmacol, 2016

Feb 2025

Ninth Circuit ruled Right to Try does NOT override Schedule I — closing the RTT pathway for psilocybin

78%

approval rate for psilocybin access requests under Canada's Special Access Programme

0

FDA expanded access approvals for psilocybin in the US, as of April 2026

Griffiths et al., J Psychopharmacol, 2016; Ross et al., J Psychopharmacol, 2016

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The direct answer to whether the Right to Try Act allows terminally ill patients in the US to access psilocybin is: no, not as of April 2026. The Ninth Circuit Court of Appeals ruled in February 2025 that the federal Right to Try Act does not override the Controlled Substances Act's Schedule I classification. A terminally ill patient and their physician cannot use the Right to Try Act to legally obtain psilocybin, regardless of the clinical evidence supporting its use for end-of-life distress.

This matters because the clinical evidence for psilocybin in terminal illness is among the strongest in the entire psychedelic research field. Two companion randomized controlled trials, both published in the same 2016 issue of the Journal of Psychopharmacology, documented response rates of approximately 60-80% for psilocybin against cancer-related depression and anxiety at 6-month follow-up. No comparable sustained response rate exists for any currently approved pharmacological option in this population. The people who responded in those trials have no legal pathway to the treatment that helped them. That gap is the central problem this article addresses. For broader context on why psilocybin remains Schedule I despite this evidence, see Why Psilocybin Is Federally Illegal Despite Proven Medical Value and the overview of psilocybin's Schedule I history.

What the 2016 Trials Showed: Why Terminal Patients Have the Strongest Claim

Two companion trials published simultaneously in the Journal of Psychopharmacology in 2016 form the scientific foundation for terminal patients' access argument.

Griffiths and colleagues at Johns Hopkins enrolled 51 patients with life-threatening cancer diagnoses in a double-blind crossover trial.^[1] Participants received either a high dose of psilocybin (22 or 30 mg/70 kg) or a very low control dose, with sessions months apart in crossover design. The high-dose session produced rapid, substantial, and sustained decreases in clinically significant depression and anxiety. At the 6-month follow-up, approximately 78% of participants showed clinically significant decreases in depressed mood and 83% showed decreases in anxiety, compared to about 23% and 14% in the low-dose control condition.

Ross and colleagues at NYU enrolled 29 cancer patients in a parallel RCT, using psilocybin at 0.3 mg/kg versus a niacin control.^[2] The psilocybin condition produced immediate, substantial reductions in both anxiety and depression. At 6.5-month follow-up, 60-80% of participants in the psilocybin group maintained a clinical response, compared to significantly lower rates in the control group. In a follow-up study four years later, approximately 57-71% of the same participants still met criteria for clinical response.

These are not borderline findings. They are among the largest and most sustained treatment effects documented for any intervention targeting cancer-related existential distress. The populations studied were patients facing their own mortality, often with inadequate pharmacological options, for whom psychological distress at end of life is both common and undertreated.

The ethical weight of this evidence is the context within which all subsequent legal analysis operates. Schonholz and colleagues, writing in the Journal of the American Academy of Psychiatry and the Law in 2024, analyzed the ethical obligations that arise when there is substantial clinical evidence for a compound's efficacy and a population with unmet need but no legal access pathway.^[3] Their analysis identified the Schedule I classification as a direct barrier to physician ethical obligations to patients with terminal illness and treatment-resistant conditions. For the clinical evidence specifically, see Psilocybin for Cancer-Related Depression and Anxiety.

What the Right to Try Act Says and Why Psilocybin Seemed to Qualify

The federal Right to Try Act was enacted on May 30, 2018, after passing with bipartisan support. Its formal title is the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017. The core provision: a terminally ill patient who has exhausted approved treatment options may request access to an investigational drug that has completed Phase 1 safety trials and is still under active clinical investigation, without needing to enroll in a clinical trial.

Psilocybin meets this criterion on its face. Phase 1 safety trials were completed. Multiple Phase 2 and Phase 3 trials are actively ongoing. The FDA granted breakthrough therapy designation for psilocybin for major depressive disorder in 2018, a formal recognition of promising clinical evidence.

The law also requires that the manufacturer agree to provide the drug and that a licensed physician oversee treatment. Both are potentially achievable. On paper, the legal pathway seemed open.

The problem is the Controlled Substances Act. Psilocybin is a Schedule I controlled substance under federal law. Schedule I classification means no currently accepted medical use and a prohibition on prescribing. The Right to Try Act does not itself modify the Controlled Substances Act, and the CSA has its own authority and enforcement mechanism — the Drug Enforcement Administration.

The DEA's position: even if a terminally ill patient and their physician both want to use psilocybin under Right to Try, the DEA must authorize the transfer of a Schedule I substance. The DEA declined to do so when Dr. Sunil Aggarwal in Washington state attempted to access psilocybin for terminal cancer patients under RTT. That refusal created the court case that resolved the legal question.

The February 2025 Ruling That Closed the Door: AIMS v. DEA

Dr. Aggarwal and the Advanced Integrative Medical Science (AIMS) Institute in Seattle filed suit challenging the DEA's refusal to grant access to psilocybin under the Right to Try Act for his terminally ill patients. The case worked through the courts and reached the Ninth Circuit Court of Appeals.

In February 2025, the Ninth Circuit ruled against the AIMS Institute. The court held that the Right to Try Act does not override the Controlled Substances Act's Schedule I restrictions. The DEA's authority to deny access to Schedule I substances is not superseded by the RTT law, because RTT and the CSA operate in different legal domains — RTT governs FDA's drug approval requirements, while CSA governs controlled substance scheduling and distribution. The court found that RTT changed FDA's approval pathway, not the DEA's scheduling authority.

The ruling is the definitive current legal status of Right to Try for psilocybin. As of February 2025, the Ninth Circuit has confirmed: the Right to Try Act cannot be used by a terminally ill patient and their physician to legally obtain psilocybin in the United States. Earlier content suggesting otherwise was written before this ruling and is now outdated. For the full legal framework explanation, see The Controlled Substances Act and Psilocybin: Legal Framework.

The Legislative Fix That Hasn't Passed: Freedom to Heal Act

The response to the structural gap the AIMS v. DEA case exposed has been legislative rather than judicial.

Senators Cory Booker and Rand Paul, joined by Representatives Mace and Blumenauer, introduced the Right to Try Clarification Act in 2022, reintroduced it in 2024. The bill would explicitly allow terminally ill patients to access Schedule I investigational drugs that have completed Phase 1 trials, creating a carve-out from Schedule I restrictions specifically for the RTT context. The bill has not passed either chamber as of April 2026.

The more recent evolution is the Freedom to Heal Act, introduced in December 2025. This legislation goes further: it would create a formal supervised access pathway for people with severe, life-threatening conditions to access Schedule I therapies including psilocybin and MDMA, with a physician registration requirement and DEA oversight structure. The approach attempts to solve the DEA authority problem directly by building a co-regulatory pathway rather than simply overriding DEA authority, which is likely to be more durable legally.

As of April 2026, the Freedom to Heal Act has not passed. Its introduction, with bipartisan co-sponsorship, indicates political momentum but does not create any current legal access. If it passes in its current form, it would establish the first legal pathway for terminally ill US patients to access psilocybin in a medically supervised context under federal law.

What Terminal Patients Can Actually Do Today

Given that Right to Try is not an available pathway and FDA expanded access for psilocybin has produced zero approvals in the US (Richard and colleagues, writing in General Psychiatry in 2025, documented no US psilocybin expanded access approvals against a 78% approval rate in Canada's parallel system),^[4] what options actually exist for a terminally ill patient or their family?

Oregon Psilocybin Services. Oregon's licensed psilocybin service centers have been operational since June 2023. The program is framed as wellness services and does not require a medical diagnosis or prescribing physician. Individual sessions are priced at approximately $1,500-2,500+ depending on the facilitator and center. Sessions typically run 5-6 hours. Licensed facilitators are trained and state-regulated. This is not a medical program and does not produce a treatment plan or medical record in the traditional healthcare sense; it is a wellness service. Terminal patients can access it under the same rules as anyone else. Oregon has 23+ operational service centers. The limitation: cost is out-of-pocket, insurance doesn't cover it, and the wellness framing means clinical documentation is limited.

Colorado Healing Centers. Colorado's program became operational June 2025. The first healing center was licensed December 31, 2024. Colorado's model is somewhat closer to a healthcare adjacent model than Oregon's — social workers and psychiatrists can integrate into licensed operations. Same accessibility principle: no diagnosis required for therapeutic services.

Canada's Special Access Programme. This is the most accessible formal clinical pathway for US patients able to travel. Health Canada reopened SAP to psilocybin in January 2022. Covered conditions include end-of-life psychological distress (directly applicable to terminal cancer patients) and treatment-resistant major depressive disorder. The approval rate through February 2024 was 78%, with 176 Canadians approved. US patients are not eligible for the SAP but may travel to receive care once approved through a Canadian physician who has obtained SAP authorization. The process requires a Canadian physician willing to apply for authorization. Richard and colleagues in their 2025 academic comparison explicitly recommended that the US adopt elements of the Canadian model given its dramatically better access outcomes.^[4]

Clinical trial enrollment. As of 2024, 134 registered clinical trials of psilocybin are listed on ClinicalTrials.gov. Some specifically target cancer-related distress and end-of-life conditions. Trial enrollment is the one option that provides access within a formal clinical research context in the US. The limitation: most trials have specific eligibility criteria that many patients won't meet, sites are geographically concentrated, and enrollment is competitive. Searching ClinicalTrials.gov for "psilocybin cancer distress" or "psilocybin end of life" and contacting sites about eligibility is the practical starting point.

Germany's compassionate access program. Germany established the EU's first psilocybin compassionate access program, allowing prescribing physicians to access psilocybin for seriously ill patients. For European patients, or US patients willing to travel to Europe, this provides another formal clinical pathway.

For a step-by-step breakdown of the individual patient application process for FDA expanded access, see Compassionate Use of Psilocybin: Individual Patient Applications.

Any of these routes will benefit from coordination with both the patient's treating physician and, for the legal pathways, an attorney familiar with psychedelic medicine regulation. The legal landscape in this area is changing faster than almost any other area of healthcare policy, and state-specific rules can differ significantly from federal law.

The Bottom Line

The Right to Try Act does not currently provide legal access to psilocybin for terminally ill patients in the United States. The Ninth Circuit's February 2025 ruling in AIMS v. DEA settled this question definitively. The clinical evidence for terminal patients — roughly 80% long-term response rates for cancer-related depression and anxiety in two companion 2016 RCTs — makes the denial of access ethically charged, and legislative responses (Freedom to Heal Act, December 2025) are pending but have not passed. Current realistic options for terminal US patients include Oregon and Colorado therapeutic service programs, Canada's SAP (78% approval rate, cross-border use possible), and clinical trial enrollment on ClinicalTrials.gov.

Frequently Asked Questions

Can a terminal cancer patient legally access psilocybin therapy?

As of April 2026, no straightforward legal pathway exists in the US for terminal cancer patients to access psilocybin through traditional medical prescribing. The Right to Try Act was ruled insufficient by the Ninth Circuit in February 2025, and FDA expanded access for psilocybin has not been approved for any US patient. Practical options include Oregon and Colorado psilocybin service programs (no diagnosis required), clinical trial enrollment, and Canada's Special Access Programme, which has a 78% approval rate for end-of-life distress and covers psilocybin.

Does Right to Try allow dying patients to use psilocybin?

No — as of the Ninth Circuit's February 2025 ruling in Advanced Integrative Medical Science Institute v. DEA, Right to Try does not override the Controlled Substances Act's Schedule I restriction on psilocybin. The court held that Right to Try governs FDA's drug approval requirements but not DEA's scheduling authority. The DEA must separately authorize access to Schedule I substances, and it has not done so for psilocybin under Right to Try. Proposed legislation (Freedom to Heal Act, December 2025) would create a pathway if passed, but it has not passed as of April 2026.

What is the current legal status of psilocybin for terminal illness?

Psilocybin remains Schedule I under federal law, meaning no legal medical prescribing exists in the US. The Right to Try Act was ruled insufficient to access Schedule I drugs by the Ninth Circuit in February 2025. FDA expanded access has not resulted in any US psilocybin approvals. State-level options exist: Oregon (operational 2023) and Colorado (operational June 2025) offer legal psilocybin therapeutic services without requiring a medical diagnosis. Australia approved psilocybin for treatment-resistant depression via the TGA in 2023. Canada's SAP covers end-of-life distress with a 78% approval rate.

What options do terminal patients have for psychedelic therapy?

The most accessible current options, in rough order of availability: (1) Oregon psilocybin services — operational, no diagnosis required, ~$1,500-2,500/session out of pocket. (2) Colorado healing centers — operational June 2025, similar model. (3) Clinical trial enrollment — search ClinicalTrials.gov for cancer distress or end-of-life psilocybin studies. (4) Canada SAP — 78% approval rate for end-of-life distress, requires a Canadian physician, accessible for patients who can travel. (5) Germany's compassionate access program — requires travel to Europe. (6) Pending US legislation (Freedom to Heal Act, December 2025) — if passed, would create a supervised Schedule I access pathway.

Can a doctor legally prescribe psilocybin for a dying patient?

No licensed physician in the US can prescribe psilocybin under federal law, as it remains Schedule I with no accepted medical use classification. The Ninth Circuit's February 2025 ruling confirmed that Right to Try does not create this prescribing authority. In Oregon and Colorado, facilitated psilocybin sessions are available through licensed service providers, but this is a wellness service framework, not a prescribing relationship. In Canada, a physician who has received SAP authorization from Health Canada may administer psilocybin to approved patients — this is the closest current equivalent to a physician-supervised clinical pathway.

Sources & References

1. 1RTHM-00426·Griffiths, Roland R et al. (2016). “Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial..” Journal of psychopharmacology (Oxford.Study breakdown →PubMed →↩
2. 2RTHM-00445·Ross, Stephen et al. (2016). “Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: a randomized controlled trial..” Journal of psychopharmacology (Oxford.Study breakdown →PubMed →↩
3. 3RTHM-01983·Schonholz, Stephanie M et al. (2024). “Legal and Ethics Concerns of Psilocybin as Medicine..” The journal of the American Academy of Psychiatry and the Law.Study breakdown →PubMed →↩
4. 4RTHM-02167·Richard, Jérémie et al. (2025). “Expanded access to psychedelic treatments: comparing American and Canadian policies..” General psychiatry.Study breakdown →PubMed →↩