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Abstract

This Comment explores the legal, ethical, and regulatory challenges surrounding the use of psilocybin-assisted psychotherapy for terminally ill patients under the federal Right to Try (RTT) Act. While psychedelics like psilocybin are demonstrating extraordinary therapeutic potential, particularly in easing end-of-life psychological distress, patients remain barred from access due to the Controlled Substances Act (CSA) and the Drug Enforcement Administration's (DEA) narrow interpretation of its authority. Through a comprehensive analysis of legislative history, regulatory frameworks, and administrative law principles, this Comment argues that the DEA's position not only misinterprets the statutory relationship between the RTT Act and the CSA, but also undermines the core purpose of the RTT: to empower patients facing life-threatening conditions to pursue promising investigational treatments when all other options have failed.

Using AEIS v. DEA as a focal lens, this Comment examines how the federal government's restrictive scheduling system has created a deadlock between evolving medical innovation and rigid drug enforcement. It situates this conflict within the broader psychedelic renaissance and highlights how evolving regulatory debates, particularly around scheduling and patient autonomy, open new legal and legislative pathways to resolve longstanding barriers.

Ultimately, this Comment proposes a range of reforms, from harmonizing RTT and CSA provisions, to establishing new drug schedules for psychedelics, to advancing legislation like the Right to Try Clarification Act. In doing so, it makes the case for a compassionate, pragmatic legal framework that honors patient autonomy at the end of life while upholding public health goals in the age of psychedelic medicine.

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