What Is the Right to Try Act and Does It Apply to Psychedelics?

Last reviewed: August 2026 · Psychedelic law changes quickly — verify current status before relying on this page.

Who this is for: Patients with serious or terminal diagnoses who have heard that the Right to Try Act might give them access to psilocybin or MDMA, their family members, and clinicians who are asked about this pathway by patients exploring their options.

The short answer

The federal Right to Try Act, signed into law in 2018, allows patients with life-threatening conditions who have exhausted approved treatments to access investigational drugs that have completed Phase 1 clinical trials but have not yet received FDA approval. Psilocybin and MDMA technically meet the Act’s definition of eligible investigational drugs. The problem is the Controlled Substances Act. Psilocybin and MDMA are Schedule I controlled substances, and the DEA’s position — affirmed by the Ninth Circuit Court of Appeals in February 2025 — is that Right to Try does not create any exemption from the CSA’s registration requirements. As of early 2026, no patient has successfully accessed psilocybin or MDMA under the Right to Try pathway.

What the Right to Try Act does

Congress passed the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act in May 2018. The law created an alternative to the FDA’s Expanded Access (compassionate use) program for patients in specific circumstances.

To use the Right to Try pathway, a patient must have been diagnosed with a life-threatening disease or condition, have exhausted all approved treatment options, be unable to participate in a clinical trial involving the eligible investigational drug, and have a physician’s certification that the drug being sought has completed Phase 1 clinical trials and meets the Act’s other eligibility criteria.

The drug itself must have completed a Phase 1 trial approved by the FDA, be in an active clinical trial that could form the basis of a future approval application or already be part of such an application, and be in ongoing active development by the manufacturer.

Right to Try does not guarantee access. It removes FDA pre-approval as a barrier. The Act requires patient consent and physician attestation, but it does not require manufacturers to provide the drug, insurance companies to pay for it, or physicians to prescribe it. Bioethicists have noted since the law’s passage that it is largely hortatory — it creates a right without mechanisms to enforce delivery of that right.

Why psilocybin appears to qualify

Both psilocybin and MDMA appear to meet the Act’s eligibility criteria for investigational drugs. Both have completed Phase 1 clinical trials. Both have received FDA Breakthrough Therapy designation. MDMA was under active review for PTSD treatment until the FDA’s August 2024 Complete Response Letter declined to approve it. Psilocybin is in ongoing Phase 2 and Phase 3 trials through multiple sponsors. Their research status is consistent with what the Right to Try Act was written to cover.

Advocates, including Dr. Sunil Aggarwal and the Advanced Integrative Medical Science (AIMS) Institute in Seattle, have made exactly this argument since 2021. The AIMS attorneys argued that psilocybin “qualifies as an eligible investigational drug” under the Act’s plain text and that the DEA did not contest that characterization in litigation.

Why the DEA says it does not apply

The DEA’s position is that the Right to Try Act, whatever it does for the FDA approval requirement, does not modify or waive the Controlled Substances Act. The two statutes operate on separate tracks. Right to Try removes the need for FDA approval as a condition of access. It does not remove the requirement under the CSA that a practitioner who administers a Schedule I substance must hold a DEA Schedule I researcher registration.

Schedule I registration is not a routine credential. It is granted for bona fide research purposes, requires institutional support and compliance with strict storage and handling protocols, and is designed for research settings — not clinical compassionate care. Dr. Aggarwal already held DEA registration for Schedule II through V substances. He argued that requiring a separate Schedule I researcher registration to administer psilocybin under Right to Try was, in effect, re-imposing an FDA-adjacent barrier that the Act was meant to eliminate, since the DEA would refer any such registration application back to FDA for review.

The DEA denied his request for a waiver of the registration requirement, stating that granting it would be “too great a departure from current law and inconsistent with public health and safety.”

What the Ninth Circuit decided in February 2025

In Advanced Integrative Medical Science Institute, PLLC v. DEA, No. 22-1568, decided February 13, 2025, the Ninth Circuit Court of Appeals upheld the DEA’s denial. The court found that the DEA had articulated sufficient reasons for its decision and that its interpretation of the relationship between the Right to Try Act and the CSA was reasonable and not arbitrary and capricious.

The key holding was that Right to Try exempts FDA approval but does not exempt the DEA’s regulatory authority under the CSA. The court stated that while the Act removed the FDA pre-approval requirement as a condition of access, it did not modify the CSA’s registration requirements that apply to Schedule I substances independently of whether FDA approval exists.

The court also noted that AIMS had not adequately demonstrated in its submissions how the proposed use would be consistent with public health and safety standards, or detailed the treatment plan and safety controls that would be implemented. The court did not entirely foreclose future attempts, but the ruling stands as the definitive resolution of the AIMS litigation as of early 2026.

What legislative efforts have tried to address this gap

Recognizing that the legal gap between Right to Try and the CSA leaves terminal patients without a workable pathway, several members of Congress have introduced legislation to create one.

In 2022, Senator Cory Booker and Senator Rand Paul introduced the Right to Try Clarification Act, which would have explicitly amended the Right to Try Act to cover Schedule I controlled substances that meet the Act’s other eligibility criteria.

In December 2025, Senators Booker and Paul, joined by Representatives Madeleine Dean and Nancy Mace, introduced the Freedom to Heal Act. This bill would create a Schedule I Right to Try physician registration process, giving physicians a defined pathway under DEA oversight to administer psilocybin and MDMA to eligible patients without requiring the standard Schedule I research registration. As of early 2026, the Freedom to Heal Act has not been enacted.

How this compares to expanded access

The FDA’s Expanded Access program — sometimes called compassionate use — is a separate pathway for accessing investigational drugs outside clinical trials. It has been available since before Right to Try and does not face the same CSA conflict in the same way, because it operates entirely within FDA’s own framework and does not attempt to route around any part of the CSA’s registration requirements.

For psychedelics, expanded access applications for Schedule I substances face the same DEA registration barrier that Right to Try faces. The Ninth Circuit decision in the AIMS case implicitly affects expanded access for Schedule I substances as well — any pathway that does not resolve the DEA registration question encounters the same wall.

Some state legislatures have created their own Right to Try laws with language that arguably covers psychedelics more clearly than the federal Act. Whether state Right to Try laws can create access pathways that the federal CSA would preempt is a question that the AIMS litigation did not fully resolve and that future litigation may address.

What this means for patients right now

A patient with a terminal diagnosis who asks their physician about accessing psilocybin or MDMA under Right to Try is asking about a pathway that does not currently function for Schedule I substances. The legal argument that it should apply has been made, litigated, and lost at the Ninth Circuit level as of February 2025. The legislative fixes that would make the pathway functional have not yet passed.

The legal options that do currently exist for patients seeking access to psilocybin are: participation in an authorized clinical trial, access through Oregon’s or Colorado’s licensed service programs, or access through New Mexico’s Medical Psilocybin Act for patients who qualify under its conditions. Each of these has its own requirements, limitations, and practical constraints. No pathway currently permits a physician to administer psilocybin outside these frameworks without DEA Schedule I research registration.

Common mistakes and misconceptions

“Right to Try means I can get psilocybin since I have a terminal diagnosis.” The Act’s eligibility criteria may cover psilocybin as an investigational drug, but that analysis does not reach the CSA barrier. The Ninth Circuit decision confirmed that Right to Try does not resolve the CSA registration requirement.

“My doctor can prescribe it under Right to Try.” Right to Try does not create a prescription pathway. Even if the CSA barrier were resolved, Right to Try does not require manufacturers to provide the substance, physicians to administer it, or any party to facilitate access.

“The DEA has to grant a waiver for compassionate cases.” The DEA has discretion under 21 U.S.C. § 822(d) to waive registration requirements, but that discretion is not unlimited and the Ninth Circuit found the DEA’s exercise of discretion in declining Aggarwal’s request to be reasonable.

“State Right to Try laws can create this access.” State Right to Try laws cannot override the federal CSA. Any state-law pathway that would require a physician to administer a federal Schedule I controlled substance without a DEA registration would remain in conflict with federal law.

When you should speak with a lawyer

You should speak with a lawyer if:

You are a patient with a serious condition seeking access to psilocybin or MDMA and want to understand what options currently exist and what their legal parameters are
You are a physician who has been asked by a patient about Right to Try access to psychedelics and want to understand the legal exposure of attempting to facilitate such access
You are tracking the Freedom to Heal Act or similar legislation and want to understand what legal change would be required to make Right to Try functional for Schedule I substances
You are a researcher or institution considering a compassionate use or expanded access application involving a Schedule I psychedelic and want to understand the DEA registration requirements that apply

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This article is public legal education, not legal advice. If your situation is specific, speak with a lawyer who practices in this area.