Executive Order Aims to Expand Therapies for Serious Mental Illness

In an effort to address the mental health treatment landscape, President Donald J. Trump signed an executive order on April 18, 2026, aimed at accelerating the development and approval of innovative therapies for serious mental illness. The directive addresses a critical public health burden, noting that over 14 million American adults suffer from serious mental, behavioral, or emotional disorders, with roughly 8 million currently relying on prescription medications that may not provide enduring relief.^1,2

“I see this executive order as a promising federal signal that psychedelic medicine is moving closer to the center of serious policy discussion. It is important to note that it does not legalize psychedelics broadly or bypass the normal evidentiary process,” Sa'ed Al-Olimat, PharmD, cofounder of the Psychedelic Pharmacists Association, said in an interview. “What it does instead is direct federal agencies to accelerate research and regulatory review, prioritize certain psychedelic drugs that already have breakthrough therapy designation, facilitate a Right to Try pathway, support federal-state collaboration, increase trial participation and data sharing, and begin rescheduling review earlier for qualifying Schedule I products that complete phase 3 trials.”

He added that this could reduce some of the slowing development and access for treatment among patients with serious mental illness who have not responded to standard treatment. However, this does not mean psychedelic medicine will immediately be adopted.

“The current treatment landscape will still be shaped by FDA review, safety and efficacy data, clinician training, operational infrastructure, controlled-substance requirements, and payer adoption,” he said. “I view the order as an important accelerant, but we are still not at the finish line.”

This executive order comes nearly 2 years after an independent FDA advisory panel voted against the use of midomafetamine-assisted therapy to treat post-traumatic stress disorder. The panel decided that the treatment was not effective at treating the mental health disorder, confirming that the benefits do not outweigh the risks associated with the drug.³

About The Executive Order

The executive order mandates national priority vouchers for psychedelic drugs that have received breakthrough therapy designations to ensure that administrative hurdles do not delay clinical reviews. Furthermore, the FDA and the Drug Enforcement Administration are directed to establish a clear pathway for eligible patients to access investigational drugs under the Right to Try Act, a move that includes providing necessary handling authorizations for Schedule I substances to treating physicians and researchers.^1,2

“The most important clarification is that Right to Try is not a research pathway in the traditional sense. It is an access pathway that can allow eligible patients with life-threatening diseases or conditions to seek certain investigational drugs outside the standard approval process, provided the product meets legal criteria and the manufacturer is willing to provide it,” Al-Olimat added. “In this executive order, the administration directs FDA and DEA to facilitate and establish a pathway for eligible patients to access psychedelic drugs under Right to Try, including necessary Schedule I handling authorizations for treating physicians and researchers, consistent with existing law. What makes that especially relevant for psychedelics is that these compounds face additional controlled-substance barriers that many investigational drugs do not.”

With the executive order, it could make the Right to Try Act realistic for certain psychedelic candidates. But access is not guaranteed; it is still dependent on eligibility, sponsors, legal compliance, and product-specific circumstances, he said.

This effort of the executive order also builds upon the HALT Fentanyl Act of 2025, which previously reformed the process for conducting medical research on controlled substances. To support these initiatives at the local level, the Secretary of Health and Human Services (HHS) will allocate at least $50 million through the Advanced Research Projects Agency for Health to partner with state governments, such as Texas, which has already established its own research consortium to accelerate ibogaine clinical trials.

The Impact on Pharmacy

Perhaps most significant for future pharmacy logistics and dispensing, the attorney general is now required to initiate a review of Schedule I products as soon as they successfully complete phase 3 clinical trials. This provision is intended to facilitate the rescheduling process as quickly as practicable upon FDA approval, potentially moving these substances into more accessible categories for clinical use. The need for such innovative solutions is underscored by the limitations of current therapies.

“I do not see psychedelics replacing current treatment algorithms outright. At least in the near term, I see them fitting in as targeted options for carefully selected patients, particularly those with serious mental illness who have not had sufficient benefit from standard therapies,” Al-Olimat added. “We have known for a long time that while many patients do benefit from conventional treatment, a meaningful share do not achieve remission through early treatment steps.”

It is important to note that in studies, modern antipsychotics like lumateperone show efficacy in preventing relapses in schizophrenia. Approximately 80% of individuals who discontinue their medication after an acute episode will experience a relapse within a year. Traditional treatments often struggle to promote long-term improvement for the most complex patients, leading the administration to prioritize real-world evidence generation through inter-agency data sharing between the HHS, FDA, and the Department of Veterans Affairs.^1,2,4

As psychedelics move toward mainstream medical acceptance, pharmacists are being positioned as essential educators and advocates who must bridge the gap between historical knowledge and contemporary clinical science. Modern research from institutions like Johns Hopkins and Harvard has demonstrated that therapies involving substances like psilocybin can produce sustained decreases in depression and anxiety symptoms, particularly when administered in controlled environments that prioritize the patient's mindset and physical setting.⁵

“This is an important moment for both optimism and discipline. The optimism comes from the fact that the federal government is now explicitly acknowledging that current approaches are not enough for a significant number of patients with serious mental illness and that psychedelic drug development deserves more attention and urgency. That alone is worth recognizing, given the many years of advocacy and scientific rigor that helped bring the field to this point,” he said.

“But the discipline is just as important,” he concluded. “We should not confuse accelerated policy attention with proof of safety, efficacy, scalability, or equitable access. Each psychedelic product is different, each indication is different, and the responsibility of clinicians, including pharmacists, is to communicate clearly about where the evidence is promising, where it is still emerging, and what still needs to be ironed out before these therapies can be integrated responsibly into care.”

READ MORE: Mental and Behavioral Health Resource Center

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REFERENCES

1. The White House. Fact Sheet: President Donald J. Trump is accelerating medical treatments for serious mental illness. April 18, 2026. Accessed April 20, 2026. https://www.whitehouse.gov/fact-sheets/2026/04/fact-sheet-president-donald-j-trump-is-accelerating-medical-treatments-for-serious-mental-illness/

2. The White House. Accelerating medical treatments for serious mental illness. April 18, 2026. Accessed April 20, 2026. https://www.whitehouse.gov/presidential-actions/2026/04/accelerating-medical-treatments-for-serious-mental-illness/

3. Meara K. FDA advisory panel votes against MDMA-assisted therapy for PTSD. Drug Topics^®. June 5, 2024. Accessed April 21, 2026. https://www.drugtopics.com/view/fda-advisory-panel-votes-against-mdma-assisted-therapy-for-ptsd

4. Biscaldi L. Lumateperone demonstrates efficacy in reducing symptomatic relapse risk in schizophrenia. Drug Topics. November 5, 2024. Accessed April 20, 2026. https://www.drugtopics.com/view/lumateperone-demonstrates-efficacy-in-reducing-symptomatic-relapse-risk-in-schizophrenia

5. Al-Olimat, S. Psilocybin mushrooms: a journey from ancient tradition to modern clinical use. Drug Topic. August 29, 2024. Accessed April 20, 2026. https://www.drugtopics.com/view/psilocybin-mushrooms-a-journey-from-ancient-traditions-to-modern-clinical-use