You Are Not Hallucinating: Executive Order Aims to Accelerate Approval of Therapeutic Psychedelics

On April 18, 2026, President Trump issued an executive order on Accelerating Medical Treatments for Serious Mental Illness, aiming to facilitate the development and approval of psychedelic drugs for the treatment of mental health disorders. While psychedelics have shown significant promise for the treatment of such disorders as post-traumatic stress disorder, mood disorders, and addiction, they face a number of development challenges. As such, while the executive order will likely bolster investigational psychedelic therapies, sponsors will still have to grapple with how to meet FDA’s standards of safety and effectiveness.

Moreover, persons and entities within the psychedelic product supply chain, including researchers, manufacturers, healthcare entities, and distributors, must prepare for the additional layers of regulation that will accompany the development and commercialization of these products.

PSYCHEDELIC EXECUTIVE ORDER

Accelerating Medical Treatments for Serious Mental Illness (the Executive Order) aims 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.”

Noting FDA’s actions to date, including Breakthrough Therapy designations (BTDs) for multiple investigational psychedelics, the Executive Order directs FDA to provide Commissioner’s National Priority Vouchers to “appropriate psychedelic drugs” that have received BTDs, paving the way for an expedited review period once New Drug Applications are submitted.

The Executive Order directs FDA and DEA to “facilitate and establish” a pathway for patients to access psychedelic therapies under the Right to Try Act, including “any necessary Schedule I handling authorizations for treating physicians and researchers . . . and any applicable waiver authority under the Controlled Substance Act.”

Finally, and in addition to requirements related to agency funding and data sharing, the Executive Order requires the Attorney General, in consultation with the Department of Health and Human Services, to review Schedule I products that have “successfully” completed phase 3 clinical trials for serious mental health disorders to allow rescheduling to proceed quickly for any products that are ultimately approved by FDA.

IMPACT OF THE EXECUTIVE ORDER

The president’s support for the development and approval of psychedelic therapies will likely strengthen the industry, potentially creating funding opportunities as well as encouraging FDA to exercise scientific judgment and flexibility when reviewing such therapies. However, given the challenges faced by the industry to date, the Executive Order does not guarantee FDA product approval, as the design and conduct of psychedelic therapy clinical trials is inherently challenging. 

As discussed by FDA in its 2023 draft guidance, Psychedelic Drugs: Consideration’s for Clinical Investigations, study blinding, bias minimization, and teasing out the effect of the drug product versus the therapeutic process can be difficult. Study sponsors and investigators must also take special precautions to ensure that adequate subject protections are in place. 

Some of these challenges came to a head in FDA’s 2024 rejection of Lykos Therapeutics’ investigational MDMA product for PTSD. In its complete response letter, FDA cited issues with study assessments of the product’s potential for abuse and duration of effect as well as the representativeness of the studies’ patient population. Although the Executive Order aims to accelerate FDA approval of psychedelic therapies, as indicated by FDA’s draft guidance and review history, sponsors will still need to meet FDA’s approval standards and contend with these challenges.

Moreover, while the Executive Order directs FDA and DEA to facilitate the use of psychedelic drugs through the Right to Try Act (which, while not mentioned, likely also extends to expanded access use under FDA’s regulations), it would not change the DEA scheduling for such drugs, many of which, until approved by FDA and rescheduled, are Schedule I.

As such, DEA Schedule I registration and associated drug security compliance will still be required, which can be burdensome. Right to Try and expanded access also require that drug sponsors be willing to supply drug products for use outside of clinical trials, which requires sponsors to weigh the various risks and benefits associated with such programs.

Additionally, while the Executive Order directs FDA and DEA to accelerate the development, approval, and use of therapeutic psychedelic therapies, it principally focuses on sponsors and healthcare providers and does not address other parts of the supply chain. Manufacturers, distributors, and pharmacies, for instance, must all hold the necessary DEA registrations and comply with the applicable requirements for the production and handling of these products.   

The Executive Order also does not directly address psychedelics that may not currently be DEA scheduled controlled substances. While these substances would likely be scheduled upon FDA approval, prior to approval and depending on their stage of development, they may be considered by DEA to be controlled substance precursors, which adds complexity to the regulatory requirements that would apply.

Moreover, even if a substance is not scheduled by DEA it may still be considered a controlled substance under state law as states maintain their own lists of controlled substances. Consequently, sponsors and other persons and entities will need to be aware of and comply these state-level requirements.

LOOKING AHEAD

While the Executive Order is welcome news for this promising therapeutic modality, it is not the closing chapter. Companies, researchers, healthcare providers, and other entities operating in this space will need to be mindful of the multiple levels of regulation and scientific considerations to enable successful and compliant development programs as well as eventual product launch and commercial use.