White House Executive Order Signals Major Policy Shift on Psychedelic-Assisted Therapies

In the United States, psychedelic substances have historically been classified as Schedule I controlled substances, defined as drugs with “no currently accepted medical use and a high potential for abuse.” However, as reflected in the EO, Accelerating Medical Treatments for Serious Mental Illness, emerging clinical data suggests that certain psychedelic compounds, including ibogaine, may offer meaningful benefits for patients with treatment-resistant mental health conditions. 

This shift is particularly relevant to the burgeoning longevity and healthspan ecosystem. Mental health, cognitive resilience, and neurological function are increasingly recognized as core components of healthspan — the preservation of functional, high-quality life over time. As a result, psychedelic-assisted therapies are gaining attention not only as treatments for acute psychiatric conditions, but also as potential tools within a more preventive, integrative approach to long-term brain health and emotional wellbeing.

Against this backdrop, the EO directs the following government actions:

• The Commissioner of the US Food and Drug Administration (FDA) will provide National Priority Vouchers to psychedelic drugs that have received Breakthrough Therapy designation and meet the criteria of the Commissioner’s National Priority Voucher Program (CNPV). The CNPV pilot program, announced in June 2025, is designed to reduce the FDA’s new drug application review timeline to one to two months through a collaborative review process and enhanced presubmission engagement.

• The FDA and the US Drug Enforcement Administration (DEA) will facilitate and establish a pathway for eligible patients to access psychedelic drugs under the Right to Try Act, which allows patients diagnosed with life-threatening diseases or conditions to access experimental drugs that have completed early clinical trials but have not yet received full FDA approval. 

• The Secretary of Health and Human Services (HHS), through the Advanced Research Projects Agency for Health, will allocate at least $50 million in existing funds to support partnerships with states advancing psychedelic treatment programs. This funding will go toward technical assistance, data sharing, and program development. 

• HHS, the FDA, and the US Department of Veterans Affairs will collaborate with one another — and where appropriate, the private sector — to increase clinical trial participation, expand data sharing, and generate real-world evidence. The EO directs these agencies to prioritize drugs that have received Breakthrough Therapy designation and sign data-sharing memoranda to ensure that data from relevant clinical studies is made available to the FDA for timely drug evaluation and approval.

• The Attorney General, in consultation with HHS, will 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. 

Critically, the EO does not alter the legal classification of any psychedelic substance or provide approval for commercial use. Nonetheless, the order signals a clear intent from the Administration to accelerate the pathway from research to approval and patient access. Indeed, FDA Commissioner Marty Makary announced at the EO signing ceremony that the FDA has issued an investigational new drug authorization for ibogaine, allowing human clinical trials involving this compound to proceed in the United States for the first time.

While the EO creates near-term momentum — with stock prices of psychedelic-focused drug developers jumping after the signing — the practical impact of the order will hinge on implementation. Notably, the order does not address questions of insurance coverage, clinician training, or health care infrastructure needed to support psychedelic-assisted therapy at scale. It also remains to be seen whether the EO will encounter delays akin to other drug reform orders, such as the December 2025 EO directing the rescheduling of marijuana, the implementation of which remains ongoing.

ArentFox Schiff will continue to monitor developments related to this EO and the federal regulatory landscape for psychedelic therapies. As this area evolves, companies that operate in the pharmaceutical, health care, life sciences, and longevity sectors should continue to assess how these policy changes may affect their product pipelines, clinical trial strategies, and compliance planning.