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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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\\u2019s recent guidance for researchers running clinical trials; how an amendment changed Colorado\\u2019s 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\\u2019s confusing program not being sustainable; and how Senate Bill 303 drastically changed confidentiality and how personal data would be collected in the state.\\xa0
He also discusses the complications and ethics of end-of-life care and psychedelics; the theoretical heart valve risk from chronic use and ways we could research this; the challenge of informed consent; the legal risk of transactions involving people gifting illegal substances; the Gracias Foundation\\u2019s recent $16 million grant to Harvard and how people at Harvard feel about psychedelics; and more.\\xa0
POPLAR, which was founded to essentially change laws around psychedelics, is hosting a conference on February 16 in Manhattan called \\u201cDrug Law for the 21st Century,\\u201d which will be looking back on 50 years of DEA drug policy and envisioning what could be different going forward.
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