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

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 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’s recent $16 million grant to Harvard and how people at Harvard feel about psychedelics; and more.  POPLAR, which was founded to essentially change laws around psychedelics, is hosting a conference on February 16 in Manhattan called “Drug Law for the 21st Century,” which will be looking back on 50 years of DEA drug policy and envisioning what could be different going forward. Click here to head to the show notes page.