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After seventeen days of hearings, Administrative Law Judge Francis L. Young recommends placing MDMA in Schedule III rather than Schedule I. He finds currently accepted medical use and accepted safety for medical supervision based on psychiatrists' testimony, animal lethality studies, and clinical experience with supervised psychotherapy.

The First Circuit vacates the DEA's rule placing MDMA in Schedule I, holding the Administrator's interpretation of 'accepted medical use' was contrary to Congress's intent. Dr. Grinspoon, a Harvard psychiatrist seeking to research MDMA therapeutically, brought the appeal after the Administrator overruled the ALJ's Schedule III recommendation.

The Supreme Court holds that Oregon may deny unemployment benefits to two Native American Church members dismissed for sacramental peyote use, since a neutral criminal drug law requires no religious exemption. Blackmun dissents.

Congress restored a nationwide exemption for the ceremonial use of peyote by Indians in connection with traditional religions. The statute carves out exceptions for prison, military, and safety-sensitive positions.

An Update (NIDA Research Monograph 146)

Proceedings of a 1992 NIDA technical review on hallucinogen research, prompted by rising LSD use among teenagers. Includes Rick Strassman's account of the regulatory process (IRB, DEA, FDA) for his DMT study, the first human hallucinogen study approved since the early 1970s.

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.