Executive Order Aims to Accelerate Research and Access to Psychedelic Treatments for Serious Mental Illness

On April 18, the President signed a new Executive Order aimed at accelerating research and access to psychedelic treatments for serious mental illness. The Policy Center has been tracking psychedelic treatments for postpartum depression, including featuring the topic at our most recent Maternal Mental Health FORUM. 

The Executive Order focuses on addressing the growing crisis of serious mental illness and suicide in the United States, particularly among high-risk populations such as veterans. It highlights the limitations of existing treatments in some patients, noting that many individuals with conditions like major depressive disorder and substance use disorder do not fully respond to current therapies.

Research suggests that psychedelics may promote neuroplasticity, allowing the brain to “rewire” and shift rigid thinking patterns. Conditions these treatments are being considered for incude, treatment resistant depression, post-traumatic stress disorder (PTSD), and substance use disorders.¹ 

To accelerate new solutions, the Order prioritizes accelerating the research, clinical testing, and regulatory review of psychedelic drugs that have shown promise in early clinical research. Key actions include:

• Fast-tracking FDA review: Psychedelic therapies that have received “Breakthrough Therapy” designation will be prioritized for review through special FDA vouchers.
• Expanding patient access: Federal agencies are directed to create clearer pathways for patients to access these treatments under the Right to Try Act, even before full approval.
• Investing in research: At least $50 million in federal funding will support state-level programs and partnerships advancing psychedelic treatment research.
• Strengthening collaboration: Federal agencies, including HHS, FDA, and the Department of Veterans Affairs, will work together with private sector partners, including pharmaceutical and biotech companies, to expand clinical trials and data sharing.
• Accelerating rescheduling: Once proven effective in late-stage trials, psychedelic substances may be more quickly reclassified under federal drug laws to allow for medical use.

While the Order does not change current law or guarantee approvals, it represents a significant federal effort to speed up research, reduce regulatory barriers, and expand access to psychedelic treatment, which has implications for maternal mental health. 

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