Key points
The Order directs federal agencies to accelerate research, regulatory review, and patient access to psychedelic drugs for serious mental health conditions.
The Order also directs federal agencies to establish a pathway for eligible patients to access investigational psychedelic drugs, allocate funds for state psychedelic drug research programs, and take other steps to expedite psychedelic drug development.
FDA promptly issued Commissioner’s National Priority Vouchers to three companies studying psychedelics for certain mental health conditions and allowed a fourth to proceed to human clinical trials.
On April 18, 2026, President Trump signed an executive order titled “Accelerating Medical Treatments for Serious Mental Illness” (the Order).Exec. Order No. 14401, 91 Fed. Reg. 21,709 (Apr. 22, 2026). The Order directs the Food and Drug Administration (FDA), Department of Health and Human Services (HHS), Drug Enforcement Administration (DEA), and Department of Veterans Affairs (VA) to take coordinated action to accelerate research, regulatory review, and patient access to psychedelic drugs as treatments for serious mental health conditions.See id.
The Order states that “[p]sychedelic drugs, including ibogaine compounds, show potential in clinical studies to address serious mental illnesses for patients whose conditions persist after completing standard therapy” and announces that it is “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.”Id. This announcement and subsequent federal agency action reflect a meaningful shift in federal policy on the therapeutic use of psychedelic drugs, as developing these products has historically been limited by regulatory obstacles, including controlled substances restrictions, that impeded clinical research.
The Order calls for coordinated action by these federal agencies across five key areas discussed below.
FDA Expedited Development and Review
The Order directs FDA to issue a Commissioner’s National Priority Voucher (CNPV) to “appropriate psychedelic drugs that have received a Breakthrough Therapy designation” and otherwise meet CNPV selection criteria.Id. FDA announced the CNPV pilot program in June 2025.FDA, FDA to Issue New Commissioner’s National Priority Vouchers to Companies Supporting U.S. National Interests (Jun. 17, 2025), https://www.fda.gov/news-events/press-announcements/fda-issue-new-commissioners-national-priority-vouchers-companies-supporting-us-national-interests. Under the pilot program, FDA has announced its intention to grant CNPVs to products deemed to align with certain “critical U.S. national health priorities,” including products intended to treat conditions for which there are currently inadequate therapies, with novel mechanisms with the potential to fundamentally change disease management, or that will reduce costs to the healthcare system.FDA, Commissioner’s National Priority Voucher (CNPV) Pilot Program (Apr. 9, 2026), https://www.fda.gov/industry/commissioners-national-priority-voucher-cnpv-pilot-program. FDA intends to provide expedited review to applications for CNPV products, with a goal of acting on these applications in one or two months.See id.
An investigational drug is eligible to receive Breakthrough Therapy designation from FDA if it is intended to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates the drug may offer substantial improvement over existing therapies.21 U.S.C. § 356(a)(1).
On April 24, 2026, FDA announced that it had issued CNPVs to three companies studying psychedelic drugs for serious mental conditions.FDA, FDA Accelerates Action on Treatments for Serious Mental Illness Following Executive Order (Apr. 24, 2026), https://www.fda.gov/news-events/press-announcements/fda-accelerates-action-treatments-serious-mental-illness-following-executive-order. The agency announced CNPVs for companies studying the following: psilocybin for treatment-resistant depression, psilocybin for major depressive disorder, and methylone for post-traumatic stress disorder. In the same announcement, FDA stated that it would allow clinical investigations of noribogaine hydrochloride, a derivative of ibogaine, to proceed under an Investigational New Drug application, meaning that the investigational product can be studied in human trials.See id.
Right to Try
The Order directs FDA and DEA to “establish a pathway for eligible patients to access psychedelic drugs, including ibogaine compounds, under the Right to Try Act.”91 Fed. Reg. at 21,709. This includes any necessary Schedule I handling authorizations for treating physicians and researchers.See id. The Right to Try Act, which was enacted during the first Trump administration, permits patients diagnosed with a life-threatening disease or condition who have exhausted approved treatment options and are unable to participate in a clinical trial of a particular investigational drug to access that unapproved drug after Phase 1 clinical trials have been completed.21 U.S.C. § 360bbb-0a.
ARPA-H Funding
HHS must allocate at least $50 million through the Advanced Research Projects Agency for Health (ARPA-H) to support state governments “that have enacted or are developing programs to advance psychedelic drugs for serious mental illnesses.”91 Fed. Reg. at 21,710. This money will be allocated from “existing funds.”Id. On April 21, 2026, ARPA-H announced that at least $50 million “to match state government investments in psychedelic research for populations with serious mental illness” would be allocated from its Evidence-Based Validation & Innovation for Rapid Therapeutics in Behavioral Health initiative.HHS, ARPA-H announces first research teams for $139 million initiative to transform behavioral health and bring new, more precise and effective treatments to Americans (Apr. 21, 2026), https://www.hhs.gov/press-room/arpa-h-announces-research-teams-initiative-transform-behavioral-health.html.
Interagency and Private Sector Collaboration
The Order directs HHS, FDA, and the VA to coordinate across agencies and the private sector “to increase clinical trial participation, data sharing, and real-world evidence generation” for psychedelic drugs.91 Fed. Reg. at 21,710. Among these drugs, the Order directs the agencies to “prioritize drugs” that have received Breakthrough Therapy designation.Id. The agencies must also “sign data-sharing memoranda as appropriate” to make clinical study data available to FDA to permit it to use such data to facilitate the evaluation of marketing applications for psychedelic drugs for serious mental illness.Id.
Early Rescheduling Review
The Order directs the Department of Justice, 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, so that rescheduling, if appropriate… may proceed as quickly as practicable.”Id. This is intended to facilitate prompt rescheduling of a specific psychedelic drug, if FDA approved.
Conclusion
The Order intends to expand research into psychedelic drugs for serious mental health conditions and to facilitate prompt regulatory review and patient access. FDA and ARPA-H took swift initial steps to implement aspects of the president’s directives, with further agency action to come in order to fully advance the president’s goal to expedite the development of psychedelic drugs. Together, these actions represent a significant federal policy shift to promote psychedelic therapies for serious mental health disorders.