Key Points

• Accelerated FDA review. The Executive Order directs the Food and Drug Administration to provide Commissioner's National Priority Vouchers to psychedelic drugs with Breakthrough Therapy designations, potentially compressing review timelines from 10 to12 months to as little as one to two months.
• Right to Try access. The FDA and Drug Enforcement Administration are directed to establish a pathway for eligible patients to access investigational psychedelic drugs under the Right to Try Act, along with any necessary Schedule I handling authorizations for treating physicians and researchers.
• Expedited rescheduling. The Attorney General is directed to initiate and complete rescheduling review of products containing a Schedule I substance upon successful completion of Phase 3 clinical trials for a serious mental health disorder, rather than waiting for FDA approval.

President Donald Trump recently signed an Executive Order that directs a constellation of federal agencies — the Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), Health and Human Services (HHS) and the Department of Veterans Affairs (VA) — to accelerate research and to access pathways for psychedelic drugs aimed at treating serious mental health conditions.

Titled "Accelerating Medical Treatments for Serious Mental Illness," the April 18, 2026, order does not legalize any psychedelic substance, though. It also does not reschedule any controlled drug.

The Order is described as responding to a mental health crisis. As the Order notes, more than 14 million American adults live with a serious mental illness and approximately 8 million rely on prescription medications to manage these conditions. Suicide rates increased by 37 percent from 2000 to 2018. The Order highlights veterans as a population of particular concern, citing more than 6,000 veteran suicides annually for over two decades and a suicide rate that is more than twice that of the non-veteran adult population. During the signing ceremony, President Trump emphasized the “life-changing potential” of psychedelic treatments for veterans.

What the Order Does

• Faster FDA Review. The Executive Order directs the FDA Commissioner to issue Commissioner’s National Priority Vouchers (CNPVs) for eligible psychedelic therapies that have received Breakthrough Therapy designation and meet the criteria of the National Priority Voucher Program. Launched in June 2025, the CNPV program aims to shorten FDA review timelines for new drug applications from the standard 10 to 12 months to a targeted one to two months using a "tumor board-style" collaborative review process. The program's five priority areas — public health crisis response, innovative breakthrough therapies, large unmet medical needs, onshoring and supply chain resilience, and affordability — extend well beyond psychedelics. FDA Commissioner Marty Makary announced that investigational new drug clearance had been granted for ibogaine, meaning U.S. clinical trials can now begin for that substance, and new drug applications are forthcoming.
• Right to Try Access. The order directs the FDA and the DEA to "facilitate and establish a pathway for eligible patients to access psychedelic drugs, including ibogaine compounds, under the Right to Try Act (21 U.S.C. § 360bbb-0a)," including any necessary Schedule I handling authorizations for treating physicians and researchers and any applicable waiver authority under the Controlled Substances Act. This provision is notable because the Right to Try Act generally requires completion of Phase 1 clinical trials. However, this provision could also impact the availability of other psychedelics under the Right to Try Act.
• Federal-State Funding. The Executive Order directs the Secretary of HHS, through the Advanced Research Projects Agency for Health (ARPA-H), to 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. This funding is expected to most immediately benefit Texas, which recently enacted a law requiring publicly funded ibogaine research and allocated $100 million for the project. The matching-fund structure may also encourage private sector investment and incentivize other states to develop psychedelic research programs.
• Interagency Data Sharing and Clinical Trial Collaboration. The order directs HHS, FDA and the VA to collaborate with each other and with the private sector, as appropriate and consistent with applicable law — including the Privacy Act of 1974 and the Health Insurance Portability and Accountability Act of 1996. The intent is to increase clinical trial participation, data sharing and real-world evidence generation regarding psychedelic drugs, with priority given to drugs that have received Breakthrough Therapy designation. The agencies are directed to sign data-sharing memoranda to ensure that clinical study data from across the executive branch is made available to the FDA to facilitate timely drug evaluation and approval. This framework could also serve as a model for other therapeutic areas — particularly regenerative medicine and rare diseases — where generating large trial datasets is often difficult.
• Timely Rescheduling. The Executive Order instructs the Attorney General 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 under 21 U.S.C. 811, may proceed as quickly as practicable" for products ultimately approved under Section 505 of the Federal Food, Drug and Cosmetic Act. By initiating review after Phase 3 completion but prior to an FDA approvability decision, the order could in theory reduce post-approval delay. The practical impact is questionable, however, considering that the DEA is already required by statute to reschedule drugs within 90 days of FDA approval.

What This Means for Your Business

• The CNPV Program Reaches Beyond Psychedelics. The CNPV program is not limited to psychedelics. Regenerative medicine companies, gene therapy developers and other manufacturers with Breakthrough Therapy or Regenerative Medicine Advanced Therapy designations should evaluate whether their products qualify. The program accepts new drug applications, biologics license applications, and manufacturing or efficacy supplements.
• A Pattern of Executive and Legislative Action. This Order follows a December 2025 executive order expanding federal support for medical marijuana and cannabidiol research. On the legislative front, the HALT Fentanyl Act significantly reformed the process for conducting medical research on Schedule I substances, which is purported to further accelerate the psychedelic drug research contemplated by this Order. Together, these developments suggest a broader convergence of executive and legislative action to advance investigational therapies facing regulatory or scheduling barriers. Companies in other novel therapeutic areas should anticipate that similar attention may be directed toward their sectors.
• Drug Scheduling Does Not Change — Yet. Importantly, the Executive Order does not alter the legal status of any psychedelic substance. All covered compounds remain Schedule I controlled substances unless and until the DEA completes a formal rescheduling process following FDA approval. As recent experiences with cannabis rescheduling demonstrate, implementation timelines can be lengthy, uncertain and politically sensitive. Companies should plan accordingly and avoid overestimating near‑term regulatory relief.
• Reimbursement and Access Are Unresolved. The Executive Order expresses a goal of expanding access to psychedelic drugs for mental health treatment, but provides limited guidance on reimbursement, payer coverage or delivery models. FDA approval alone is not sufficient to ensure patient access — stakeholders must also consider how payers will approach coverage and how these therapies will be delivered in practice. In particular, the scope and structure of any Risk Evaluation and Mitigation Strategy (REMS) imposed by the FDA will heavily influence provider participation, treatment costs and patient reach.
• Watch State Medical Board Guidance. State medical boards and other professional licensing bodies operate independently of the FDA. Providers should closely monitor board guidance on psychedelic‑assisted therapies. Failure to adhere to evolving professional standards could expose providers to disciplinary risk, even where federal approval is obtained.
• Political Risk Cuts Both Ways. The Executive Order’s origins in political relationships — rather than a traditional agency‑driven process — underscore how regulatory pathways for novel therapies are increasingly shaped by political dynamics. Companies should maintain strong government affairs capabilities and be prepared for both regulatory acceleration and sudden shifts in direction.

What Comes Next

The Executive Order is a landmark signal of Administration support for psychedelic therapies. But the order is not self-executing. Its ultimate impact will depend on how FDA, DOJ/DEA, HHS and other stakeholders design and implement the directives. The order is also expressly subject to the availability of appropriations, which may affect the timing and scale of promised funding. Key questions remain open — including the practical scope of Right to Try access, the timing and certainty of rescheduling, and the reimbursement frameworks that will shape real-world patient access.

For more information, please contact Akshay Krishnamani at 312.276.1328 or akrishnamani@foxrothschild.com, or another member of Fox Rothschild’s national Cannabis Law Practice Group.

This information is intended to inform firm clients and friends about legal developments, including the decisions of courts and administrative bodies. Nothing in this alert should be construed as legal advice or a legal opinion. Readers should not act upon the information contained in this alert without seeking the advice of legal counsel. Views expressed are those of the authors and not necessarily this law firm or its clients.