Notwithstanding that the U.S. Food and Drug Administration (FDA) has twice designated psilocybin a Breakthrough Therapy—first for treatment-resistant depression and then for major depressive disorder, the U.S. Drug Enforcement Administration (DEA) has steadfastly refused to even initiate the process for rescheduling the drug. In early 2021, Dr. Sunil Aggarwal and Advanced Integrative Medical Science Institute, PLLC asked the DEA how he might obtain psilocybin for therapeutic use under Right to Try laws. In response, DEA said it had no authority to permit such uses because psilocybin is a schedule I drug permitted for research use only.
DEA’s refusal to accommodate access to psylocibin under RTT, let alone open a scientific review related to a rescheduling petition, not only undermines congressional goals, but also exceeds its authority. The food, drug and cosmetics act (FDCA), controlled substances act (CSA) and right to try (RTT) laws were created to protect the life and health of the public from dangerous and ineffective medications. But as was learned during the early days of the HIV/AIDS when those legal protections only produce suffering and death, they serve no legitimate legal and public health purpose. Sometimes government can do best for its citizens by simply stepping out of the way.
This program will explore the potential therapeutic role of Psilocybin, and the paths available to meaningful scientific review of its use.
Speakers:
- David N. Hoffman, J.D., Assistant Professor of Bioethics, Columbia University
- Steven P. Field, M.D., Clinical Assistant Professor, Department of Medicine at NYU Grossman School of Medicine; Medical Ethics Consultant, NYU Langone Medical Center
- Linda Brooks Uchal, Research Pharmacist
- Daniel Arshack, Criminal Defense Attorney, Co-Founder of The Bronx Defenders, Managing Partner of Arshack, Hajek and Lehrman, PLLC, and Founding Member of the International Criminal Bar
This event is eligible for Continuing Legal Education credits (CLE) for attorneys licensed in the State of New York.
PROGRAM AGENDA AND READINGS
CLE FORMS TO COMPLETE
