This post is part of Notice & Comment’s symposium on psychedelics and the law. For other posts in the series, click here. On April 18, 2026, President Trump issued Executive Order 14401, “Accelerating Medical Treatments for Serious Mental Illness,” with the purpose of “increase[ing] access to psychedelic drugs that could save lives and reverse the crisis of […]

This post is part of Notice & Comment’s symposium on psychedelics and the law. For other posts in the series, click here. The expansion of psychedelic medicine has brought neuropsychiatry and pharmaceutical law to a structural, methodological, and institutional crossroads. Federal law requires “substantial evidence of efficacy” (FDA Act §505(d)) and regulations (21 CFR 314.126) mandate that […]

This post is part of Notice & Comment’s symposium on psychedelics and the law. For other posts in the series, click here. Imagine two competent adult patients, each of whom is living with treatment-resistant major depressive disorder (MDD) and struggling with suicidal ideation. Patient A asks her doctor about Pretendazine®, an (imaginary) injectable drug FDA-approved exclusively for […]

This post is part of Notice & Comment’s symposium on psychedelics and the law. For other posts in the series, click here. Dr. Sunil Aggarwal runs an “integrative oncology clinic” in Seattle, Washington, where he treats patients with late-stage cancer. Some of those patients suffer from the anxiety and depression that often accompany a terminal diagnosis. Aggarwal […]