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AI Summary: This regulation establishes a policy to accelerate the development and approval of innovative treatments, specifically psychedelic drugs, for serious mental illnesses. It defines serious mental illness as a diagnosable mental, behavioral, or emotional disorder that significantly impacts a person's life and functioning. The regulation aims to address the persistent challenges of suicide and serious mental illness rates in America, noting a rebound in suicide rates after a temporary decrease. Key provisions include prioritizing Food and Drug Administration (FDA) review for psychedelic drugs that have received Breakthrough Therapy designation, facilitating patient access to these drugs under the Right to Try Act, allocating at least $50 million from existing funds to support state-level programs advancing psychedelic drug research, and directing HHS and FDA to collaborate with the Department of Veterans Affairs (VA) and the private sector to increase clinical trial participation and data sharing. The Attorney General is also directed to expedite the review process for rescheduling Schedule I substances that have successfully completed Phase 3 clinical trials and are approved by the FDA for serious mental health disorders.