Psychedelics Today

PT469 – Mason Marks, MD, JD – Drug Policy in 2023: The FDA's Guidance for Clinical Trials, The Natural Medicine Act, and SB-303

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Sinopse

In this episode, Joe interviews Mason Marks, MD, JD: drug policy analyst, writer, Professor at the Florida State University College of Law, and senior fellow and project lead of the Project on Psychedelics Law and Regulation (POPLAR) at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics. As somewhat of an expert on drug policy and FDA regulation, Marks discusses much of the current legal landscape: What was controversial and most interesting about the FDA’s recent guidance for researchers running clinical trials; how an amendment changed Colorado’s Natural Medicine Act and the odd vibe coming from the rule-making process (very private with canceled meetings and a notable lack of urgency); concerns over Oregon’s confusing program not being sustainable; and how Senate Bill 303 drastically changed confidentiality and how personal data would be collected in the state.  He also discusses the complications and ethics of end-of-life care and psychedelics; the theoretical heart valve risk from