Lisa Gora, James Boiani, and Marylana Helou, Members of the Firm, co-present “Legal and Regulatory Challenges in Psychedelic Research and Commercialization,” Part 2 of a webinar series hosted by the Blue Cross Blue Shield Association.
In Part 2 of this two-part series, the panel discusses how psychedelic drugs are gaining increased favor as potential treatments for a number of psychiatric conditions.
Recent data has shown promise for the use of MDMA, psilocybin, and LSD to treat depression and trauma-based conditions, not to mention the increasingly widespread use of FDA-approved ketamine for treatment refectory depression. As with MDMA, the FDA has designated a psilocybin analog as a “breakthrough therapy” – granted to promising novel therapies that preliminary data suggests may provide advances over available treatments. Also, while two states (Colorado and Oregon) and a number of cities across the US have decriminalized the use of psilocybin for therapeutic and non-therapeutic purposes, these currently remain illegal at the federal level as Schedule 1 substances (with “no currently accepted medical use and a high potential for abuse”) under the Controlled Substances Act.
Conducting research on psychedelic drugs raises unique ethical, legal, and regulatory challenges. When do FDA regulations apply and what is FDA’s position with respect to psychedelic research? How should researchers resolve conflicting federal and state laws? What other legal and regulatory concerns must researchers consider? Also, taking products from clinical investigation to market requires navigating further hurdles in terms of trial designs to establish efficacy, quantifying and managing safety concerns, and building a framework for reimbursement that can succeed. This session will address these issues, providing some key points of consideration relevant to development and commercialization of these promising therapies.
For more information, visit the BCBS Association event website.
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