Chief Justice Roberts holds the federal government failed to show a compelling interest justifying its ban on the Uniao do Vegetal church's sacramental use of hoasca (ayahuasca tea with DMT) under the Religious Freedom Restoration Act. The Court rejects the UN Convention argument and upholds the peyote precedent for religious exemptions to the Controlled Substances Act.
A federal court ruling applying Gonzales v. O Centro to the Santo Daime church in Oregon, granting the right to import and drink ayahuasca under RFRA. Judge Panner's findings describe the religion's origins, ritual, physiological effects, and the government's health and diversion evidence.
Oregon's 2020 ballot measure created the first US state-licensed psilocybin services program. The findings cite FDA's breakthrough-therapy designation for depression, and the statute establishes licensed service centers and facilitators rather than unsupervised legalization.
The transcript of the FDA advisory committee that reviewed Lykos Therapeutics' application for MDMA-assisted therapy for post-traumatic stress disorder. Hosted here are the chair's opening of the committee questions and the two votes: 2 to 9 against finding the drug effective, and 1 to 10 against finding that its benefits outweighed its risks, with each member's stated reasons. Members cited functional unblinding, expectation bias, the many trial participants who had used MDMA before, and reports of misconduct. The FDA declined to approve the application in August 2024.
Considerations for Clinical Investigations (Guidance for Industry)
FDA guidance (July 2026) for sponsors developing psychedelics—5-HT2A agonists including psilocybin and LSD, plus MDMA—as approved medicines. It addresses the regulatory pathway for Schedule I drugs in clinical trials and identifies methodological challenges: perceptual effects complicate blinding ('functional unblinding'), and the independent contribution of psychotherapy paired with dosing remains uncharacterized.