Psychedelics and the Executive Order: From Schedule I to Treatment Priority

On April 18, 2026, President Donald Trump signed an executive order (Order) titled Accelerating Medical Treatments for Serious Mental Illness, directing federal agencies to expedite the research, review, and approval of psychedelic drugs as potential treatments for serious mental health conditions. The Order represents a significant federal policy shift aimed at addressing what the Trump Administration describes as a crisis of serious mental illness in America, with particular emphasis on patients whose conditions have not responded to standard therapies.

Importantly, the Order does not, by itself, approve any psychedelic drug for medical use or create enforceable rights for patients or providers. Nonetheless, it signals a substantial directional shift in federal policy that is likely to accelerate the pace of psychedelic drug development and may increase investment in the sector and reshape the regulatory environment for years to come.

We discuss key provisions of the Order and highlight its implications for clinical researchers, health care providers, and the broader medical community.

Key Takeaways

• This is a significant federal policy shift aimed at developing psychedelic drugs for use in treating mental illness.
• The Order reshapes the regulatory environment for investigating the use of psychedelic drugs, including through U.S. Food and Drug Administration (FDA) review prioritization and potential Right to Try Act access for investigational psychedelic drugs.

• The Order increases research funding for investigating the use of psychedelic drugs.
• The Order directs expedited controlled substance scheduling review for certain psychedelic drugs.
• More clinical research is needed on the safety and efficacy of psychedelic drugs.

Background

The Order acknowledges that policymakers and the medical field have long struggled to address the burden of suicide and serious mental illness in the United States. According to the National Institute of Mental Health, an estimated 15.4 million adults in the United States live with serious mental illness. Per the Order, about eight million Americans are on prescription medications for these conditions, and existing treatments such as selective serotonin reuptake inhibitors (SSRIs) are not always effective or accessible for all patients. Veterans are at particular risk, with research showing that suicide rates are nearly twice as high among veterans as they are in the general population.

The Order identifies psychedelic drugs — including ibogaine compounds — as showing potential in clinical studies to address these conditions. Notably, FDA has already granted Breakthrough Therapy designation to nearly a dozen specific psychedelic drugs, including Compass Pathways’COMP360 psylocibin program for treatment resistant depression, Resilient Pharmaceuticals’ (formerly Lykos Therapeutics) MDMA-assisted therapy program for post-traumatic stress disorder, and Definium’s DT120-LSD D-tartrate orally disintegrated tablet for generalized anxiety disorder, and there are numerous products currently in the clinical trial pipeline undergoing review of safety and efficacy. Accordingly, the Order declares it the policy of the Trump Administration “to accelerate innovative research models and appropriate drug approvals to increase access to psychedelic drugs that could save lives and reverse the crisis of serious mental illness in America.”

Key Provisions of the Executive Order

To achieve the overarching policy declaration, the Order directs several federal agencies to take immediate action:

• FDA Review Prioritization. The Order directs the Commissioner of the FDA to provide Commissioner’s National Priority Vouchers (“priority vouchers”) to psychedelic drugs that have received a Breakthrough Therapy designation and that satisfy the criteria of the National Priority Voucher Program. The Commissioner’s National Priority Voucher Program is a FDA pilot program announced in June 2025. The primary purpose of the pilot program is to explore a pathway to dramatically reduce review times for drug and biological product applications with a one- to two-month review target.  
  
  On April 24, 2026, merely six days after the Order was issued, FDA Commissioner Marty Makary announced that FDA had issued three priority vouchers to the following programs: (1) Compass Pathways’ psilocybin (COMP360) for treatment-resistant depression; (2) Usona Institute’s psilocybin for major depressive disorder; and (3) Transcend Therapeutics’ methylone (TSND-201) for PTSD, which is expected to be acquired by Otsuka Pharmaceutical Co. in Q2 2026. Notably, the voucher for Transcend Therapeutic’s methylone program — which is entering Phase 3 — came as a surprise to many industry observers, who had expected the third voucher to go to Resilient Pharmaceuticals (formerly Lykos Therapeutics) for its MDMA-assisted therapy for PTSD, which FDA declined to approve in August 2024.

• Right to Try. The Order further directs FDA and the Drug Enforcement Administration (DEA) to facilitate and establish a pathway for eligible patients to access psychedelic drugs, including ibogaine compounds, under the Right to Try Act. This includes any necessary Schedule I handling authorizations for treating physicians and researchers consistent with 21 U.S.C. § 823, as well as any applicable waiver authority under the Controlled Substances Act.

• Federal-State Collaboration and Funding. The Secretary of Health and Human Services (HHS) is directed to allocate at least $50 million from existing funds, through the Advanced Research Projects Agency for Health (ARPA-H), to support and partner with state governments that have enacted or are developing programs to advance psychedelic drugs for serious mental illnesses. This support may include federal funding, technical assistance, and data sharing, as appropriate and consistent with applicable law.

• Interagency and Private-Sector Collaboration. HHS and FDA are directed to collaborate with the Department of Veterans Affairs (VA) and, as appropriate and consistent with applicable law — including the Privacy Act of 1974 and the Health Insurance Portability and Accountability Act of 1996 (HIPAA) — with the private sector, to increase clinical trial participation, data sharing, and real-world evidence generation regarding psychedelic drugs. Priority is to be given to drugs that have received a Breakthrough Therapy designation. HHS, FDA, and VA are further directed to sign data-sharing memoranda to ensure that data from relevant clinical studies conducted by federal agencies are made available to FDA to facilitate timely evaluation and approval under Section 505 of the Federal Food, Drug, and Cosmetic Act.

• Timely Rescheduling. Lastly, the Order directs the Attorney General, in consultation with HHS, to initiate and complete review of any product containing a Schedule I substance that has successfully completed Phase 3 clinical trials for a serious mental health disorder. The objective is for rescheduling, if appropriate under 21 U.S.C. § 811, to proceed as quickly as practicable for products that are ultimately approved under Section 505 of the Federal Food, Drug, and Cosmetic Act.

Implications for Clinical Research

The Order has the potential to meaningfully reshape the landscape for psychedelic drug research. By directing FDA and DEA to reduce longstanding regulatory barriers, the Order may make it considerably easier for researchers to study psychedelic substances that are currently classified as Schedule I, a classification that imposes significant hurdles on researchers by treating these substances as having no accepted medical use and a high potential for abuse.

However, important caveats remain. The Order is not equivalent to FDA approval, and full clinical trials demonstrating safety and efficacy are still required. The emphasis on ibogaine has drawn particular scrutiny from the research community, given that ibogaine is at an earlier stage of clinical development than compounds like psilocybin or LSD and has raised safety concerns related to cardiotoxicity. Additionally, it remains debatable whether an executive order can compel rescheduling of a controlled substance. 

Implications for Health Care Providers

Health care providers should closely monitor the regulatory developments anticipated in the coming months. The Order’s Right to Try provisions are particularly noteworthy: by directing FDA and DEA to establish a pathway for eligible patients to access psychedelic drugs — including Schedule I handling authorizations for treating physicians — the Order may expand the circumstances under which physicians can administer or prescribe investigational psychedelic treatments. Providers who treat patients with serious mental illness, especially treatment-resistant depression, PTSD, and substance use disorders, should be prepared for potential new treatment pathways.

That said, the practical implementation of psychedelic-assisted therapies presents substantial infrastructure challenges. Unlike conventional medication visits, psychedelic treatment models may involve sessions lasting six to eight hours with therapist support throughout. Providers and health systems will need to address questions of staffing, facility requirements, therapist training, insurance reimbursement, and equitable access, particularly for patients in rural, lower-income, or underserved communities.

Significance for the Broader Medical Community

The Order represents a historic moment in U.S. drug policy and mental health treatment. For instance, the Multidisciplinary Association for Psychedelic Studies (MAPS) has characterized the Order as “a meaningful shift in the federal government’s approach to psychedelic policy and drug development.”

Although the Order has been largely praised by stakeholders across the pharmaceutical, health care, and advocacy sectors, caution should be taken to ensure that implementation is guided by rigorous science, patient safety, and ethical frameworks. MAPS has emphasized that expanding access must be accompanied by “strong ethical commitments: frameworks developed with Indigenous people, responsible global partnerships, accessible public education, and protections against extractive or purely commercial approaches.”

Looking Ahead

Organizations engaged in clinical research, drug development, health care delivery, and health policy should monitor several near-term developments closely. Specifically, now that FDA has issued the three priority vouchers, stakeholders should watch for the submission and expedited review of new drug applications from these companies; the establishment of Right to Try Act pathways for psychedelic drugs and associated Schedule I handling authorizations; the allocation and distribution of $50 million in ARPA-H funding for state programs; the execution of data-sharing memoranda among HHS, FDA, and VA; and DEA and HHS review of products containing Schedule I substances that complete Phase 3 trials.

For stakeholders across the pharmaceutical, health care, research, and investment sectors, the Order represents a pivotal opportunity to shape the future of mental health treatment in America. Drug developers and life sciences companies may benefit from accelerated FDA review timelines, increased federal funding, and clearer regulatory pathways that could reduce both the cost and duration of bringing psychedelic therapies to market. At Foley, we are tracking these developments closely and actively advising providers across the country on how to respond to this evolving legal landscape. From policy development and compliance strategy to enforcement defense, we are here to help. Please reach out to the authors, your Foley relationship partner, or to our Health Care Practice Group and Health Care & Life Sciences Sector with any questions.