Psychedelic-assisted therapies are moving from the margins of medical science and approaching the center of federal and state health policy with remarkable speed. What was once a fringe area of research – hampered for decades by Schedule I status, limited federal funding, and regulatory skepticism – is now the subject of a Presidential Executive Order, bipartisan Congressional legislation, action by the U.S. Food and Drug Administration (FDA) and the U.S. Drug Enforcement Administration (DEA), vocal advocacy by the Secretary of Health and Human Services (HHS), and active legislative initiatives in nearly 30 states. The convergence of these forces represents the most significant shift in federal and state psychedelic policy since enactment of the Controlled Substances Act of 1970, and it is reshaping the landscape for sponsors, investors, health care providers, manufacturers, and the patients they serve.
On April 18, 2026, President Donald Trump issued an Executive Order, “Accelerating Medical Treatments for Serious Mental Illness” (EO), which seeks to accelerate the research, development, and availability of psychedelic-assisted therapies. Through the EO, the President is directing federal agencies to prioritize increasing the number of approved and qualifying psychedelic substance treatments for patients with serious mental health conditions.
This EO could meaningfully shift the therapeutic psychedelics landscape with the following key directives:
- Review Prioritization
- The President is directing the FDA Commissioner to issue Commissioner’s National Priority Vouchers (NPVs) to qualifying psychedelic drug products that have received “Breakthrough Therapy” designation and that satisfy the eligibility criteria of the NVP Program. The program, a pilot initiative announced in June 2025, is intended to evaluate a pathway for significantly expedited review of drug and biological product applications, with a target review timeframe of approximately one to two months.
- On April 24, 2026, FDA issued three NPVs to (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, an MDMA-like compound entering Phase 3) for PTSD. Notably, the award to Transcend Therapeutics was unexpected by many industry observers, who had anticipated the third voucher would go to Resilient Pharmaceuticals (formerly Lykos Therapeutics) for its MDMA-assisted therapy. This is the product FDA declined to approve in August 2024 due to trial design and safety monitoring concerns.
- Right to Try
- The President is also directing FDA and 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 granting 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.
- Funding for Federal-State Collaboration
- The President is further directing the Secretary of HHS to, through the Advanced Research Projects Agency for Health, allocate at least $50 million from existing funds to support and partner with state governments that have enacted or are developing programs to advance psychedelic drugs for serious mental illnesses, including through federal funding, technical assistance, and data sharing as appropriate and consistent with applicable law.
- Federal Agencies and Private-Sector Collaboration
- The President is additionally directing HHS and FDA to coordinate with the U.S. Department of Veterans Affairs (VA) and, where appropriate and consistent with applicable law (including the Privacy Act of 1974 and the Health Insurance Portability and Accountability Act (HIPAA) of 1996), with private-sector partners to expand clinical trial participation, improve data sharing, and support the development of real-world evidence for psychedelic drug products, with priority given to those designated as Breakthrough Therapies. The President is further directing HHS, FDA, and VA 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 the federal Food, Drug, and Cosmetic Act.
- Timely Rescheduling
- Lastly, the President is directing the Attorney General to, in consultation with HHS, 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, for appropriate and expeditious rescheduling under the Controlled Substances Act.
Looking Forward
The EO signals the White House’s support for psychedelic-assisted therapies and has the potential to reshape the landscape for research and development. By directing FDA and DEA to prioritize and, where possible, streamline existing regulatory pathways, the EO may reduce some of the practical friction associated with researching psychedelic substances. However, it does not modify the underlying statutory framework. Crucially, it does not reschedule psychedelics from Schedule I, and those substances therefore remain subject to stringent registration, security, and handling requirements that researchers must continue to navigate.
At the clinical development stage, expedited review mechanisms – such as NPVs and increased inter-agency coordination – may shorten review timelines for qualifying products, particularly those with Breakthrough Therapy designation. That said, these tools do not relax evidentiary standards. Psychedelic trials remain inherently difficult to design due to challenges with blinding, expectancy bias, and isolating the drug’s effect from the accompanying therapeutic process.1
The EO’s explicit inclusion of ibogaine further highlights federal interest in novel treatments for serious conditions such as PTSD, depression, and traumatic brain injury. However, ibogaine also illustrates the sector’s core challenges: safety risks, including cardiac toxicity, limited large-scale clinical data, and its current Schedule I status. As a result, even with increased regulatory attention, ibogaine-based therapies are unlikely to advance without substantial additional evidence addressing these concerns.2
Finally, the EO leaves broader supply chain and state-law considerations unaddressed. Entities involved in manufacturing, distribution, and dispensing must still comply with applicable DEA registration requirements, and state-controlled substance laws may independently restrict activities even where federal policy evolves.
The Broader Washington Landscape
The EO does not exist in a vacuum. It is, however, the most visible expression of a broader and rapidly accelerating federal and state policy movement that stakeholders across the psychedelic therapeutic space should be tracking closely.
HHS Secretary Kennedy’s Support. HHS Secretary Robert F. Kennedy Jr. has been among the most vocal executive branch advocates for psychedelic-assisted therapies. At a House Energy and Commerce Committee hearing on June 24, 2025, Secretary Kennedy stated that he hopes a psychedelic pharmaceutical would be approved within the next 12 months, remarking that “[t]his line of therapeutics has tremendous advantage if given in a clinical setting, and we are working very hard to make sure that happens within 12 months.” Kennedy’s public alignment with the therapeutic psychedelics movement, and his role overseeing HHS, gives these statements particular weight for companies and investors watching regulatory posture.3
Congressional Action. Congress has been active on psychedelics across party lines. The bipartisan Psychedelics Advancing Therapies (PATH) Caucus, co-chaired by Representatives Lou Correa (D-CA) and Jack Bergman (R-MI), introduced the Innovative Therapies Centers of Excellence Act of 2025, which would establish a network of VA-designated research centers to study psychedelic therapies for veterans with PTSD, substance use disorder, and depression. Separately, Senators Cory Booker (D-NJ) and Rand Paul (R-KY), together with Representatives Madeleine Dean (D-PA) and Nancy Mace (R-SC), introduced the bipartisan Freedom to Heal Act, which would create a new DEA physician registration process enabling administration of Schedule I substances to patients with severe, life-threatening conditions where Phase I clinical trials have been completed. Because the existing Right to Try Act does not extend to Schedule I substances, the bill would establish an entirely new access pathway rather than merely expanding the existing framework – a significant potential access pathway for psychedelic therapies. The Department of War (formerly known as the Department of Defense) has also committed $9.8 million – two grants of $4.9 million each under the 2024 Defense Appropriations Act – to fund MDMA-assisted therapy studies for active-duty service members, one at Walter Reed National Military Medical Center and one at Emory University in partnership with the STRONG STAR consortium.4 These mark the first sanctioned trials of MDMA for PTSD in active-duty personnel. The unusual breadth of the political coalition supporting these efforts, spanning libertarian Republicans, progressive Democrats, and veteran-aligned conservatives, reflects the degree to which psychedelic therapeutics has moved from the margins to the mainstream of federal health policy.
Additional FDA Actions. Concurrent with the NPV issuances, FDA authorized the first U.S.-based clinical trial of an ibogaine-related compound, clearing DemeRx’s Phase 1 trial of noribogaine hydrochloride, a metabolite of ibogaine thought to carry a more favorable cardiac safety profile, for alcohol use disorder.5 FDA has also signaled that final guidance for sponsors developing serotonin-2A agonists and related psychedelic products is forthcoming.6 That guidance is expected to address the persistent methodological challenges that have complicated psychedelic trials to date, including blinding integrity, psychotherapy co-intervention standardization, and patient monitoring requirements. These developments represent the first comprehensive regulatory framework signal from FDA for the psychedelic drug development space.
State-Level Momentum. Federal activity is being reinforced and, in some cases, outpaced by state legislatures. Utah enacted legislation in March 2026 authorizing a state-funded clinical study of psychedelic-assisted therapy for veterans with treatment-resistant PTSD, attracting broad support among veterans advocacy groups.7 New Jersey signed into law a $6 million hospital-based psilocybin research pilot program in January 2026.8 Massachusetts’ Joint Committee on Mental Health voted in March 2026 to advance two separate psychedelic-assisted therapy pilot bills. Texas committed $50 million to ibogaine clinical trials under Senate Bill 2308 (signed June 2025), though as of early 2026 the state was still in the process of selecting a research consortium and trials had not yet commenced. Arizona enacted a law (SB 1555) that would automatically permit regulated access to a pharmaceutical psilocybin product upon FDA approval – the state’s rescheduling trigger approach.9 10 Nearly 30 states have active psychedelic policy proposals under consideration.11 12 The aggregate effect is a state-level regulatory environment that is increasingly running ahead of federal action, creating both opportunity and complexity for sponsors, providers, and investors operating across jurisdictions.
How We Can Help
The pace of regulatory and legislative change in the psychedelic therapeutics space is accelerating rapidly, and the stakes – clinical, commercial, and legal – are significant. Whether you are a sponsor navigating the NPV or Breakthrough Therapy designation process, an investor evaluating pipeline assets, a health care provider seeking to understand the Right to Try and expanded access pathways, or a manufacturer or distributor assessing DEA registration and supply chain requirements in a shifting federal landscape, the decisions you make now will shape your position as this market develops. We regularly counsel clients across the full spectrum of the drug development and commercialization life cycle, including regulatory strategy, DEA and FDA compliance, state law navigation, corporate transactions, and policy advocacy. We would welcome the opportunity to discuss how these developments affect your specific situation. Please do not hesitate to contact the authors or the Saul Ewing attorney with whom you regularly work.
1Jennifer Couzin-Frankel, Psychedelic Drug Studies Face a Potent Source of Bias: The ‘Trip’, Science (Mar. 3, 2025), https://www.science.org/content/article/psychedelic-drug-studies-face-potent-source-bias-trip.
2Nora Bradford, RFK Jr. Praises Ibogaine for Depression Treatment. Is the Psychedelic a Magic Bullet?, Scientific American (Apr. 24, 2026), https://www.scientificamerican.com/article/rfk-jr-praises-ibogaine-for-depression-treatment-is-the-psychedelic-a-magic-bullet/. See also Kirsten N. Cherian et al., Magnesium–Ibogaine Therapy in Veterans with Traumatic Brain Injuries, Nature Medicine (Jan. 5, 2024), https://doi.org/10.1038/s41591-023-02705-w (Stanford Medicine observational study finding significant reductions in PTSD, depression, and anxiety among 30 special operations veterans following ibogaine treatment administered with magnesium).
3House Energy and Commerce Subcommittee on Health Hearing: The Fiscal Year 2026 Department of Health and Human Services Budget, June 24, 2025, 9:00 am CDT, https://www.youtube.com/watch?v=A9lVEXRMFkQ&t=3s.
4Report to the Committees on Armed Services of the Senate and the House of Representatives Program of the Department of Defense to Study Treatment of Certain Conditions Using Certain Psychedelic Substances, Annual Update (January 2026).
5DA News Release: FDA Accelerates Action on Treatments for Serious Mental Illness Following Executive Order (April 24, 202), https://www.fda.gov/news-events/press-announcements/fda-accelerates-action-treatments-serious-mental-illness-following-executive-order.
6Id.
7Utah H.B. 390, Veterans PTSD Clinical Research Amendments, 2026 Gen. Sess. (Utah 2026) (signed into law Mar. 19, 2026).
8Public Law P.L.2025, c.296 (Session 2026 – 2027), https://njleg.state.nj.us/bill-search/2026/A1526.
9Massachusetts H2203 (194th) (Current), https://malegislature.gov/Bills/194/H2203.
10Massachusetts H4200 (194th) (Current), https://malegislature.gov/Bills/194/H4200.
11FDA News Release: FDA Accelerates Action on Treatments for Serious Mental Illness Following Executive Order (April 24, 2026), https://learneuphoria.com/psychedelic-reform-sweeps-the-nation-nearly-30-states-debate-change/.
12State of Arizona, Senate, Fifty-seventh Legislature, First Regular Session, 2025 CHAPTER 231, SENATE BILL 1555.
