In August 2024, the FDA rejected Lykos Therapeutics’s New Drug Application for MDMA-assisted therapy to treat posttraumatic stress disorder (PTSD). The decision surprised many as just seven years earlier, the agency had granted MDMA breakthrough therapy designation to treat PTSD based on positive preliminary reports.  The rejection sparked strong criticism from psychedelics and mental health […]

Over the past three decades, advocates have convinced a growing number of states to authorize the medical use of drugs that lack Food and Drug Administration (FDA) approval. To date, forty-one states have legalized the medical use of marijuana, and at least three states have legalized therapeutic use of psilocybin. The passage of these state […]

Over the past quarter century, we have witnessed a resurgence in medical, scientific, and societal interest in a broad family of psychoactive compounds that itself somewhat defies very clear pharmacological classification. Yet, these compounds have captured our attention given their unique and somewhat peculiar effects on the mind, and their growing potential as novel and […]

Religious use of psychedelics is largely thought to be bookended by two Supreme Court decisions. The first, Employment Division v. Smith (1990), rejected a constitutional exemption for Native American peyote use and held that the Free Exercise Clause does not require exemptions from neutral and generally applicable laws. Congress responded with the Religious Freedom Restoration […]

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 […]