Regulations
PT469 – Drug Policy in 2023: The FDA’s Guidance for Clinical Trials, The Natural Medicine Act, and SB-303
December 15, 2023
Featuring: Mason Marks, MD, JD
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.
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.
Notable Quotes
“I love the law because it’s sort of the rules by which society functions, and I think that’s why law in psychedelics is so interesting. And that’s why we founded this project, POPLAR, in the first place, was that we saw that there were academic, medical programs popping up all over the world (so they’re focusing on clinical trials), but it’s really the law that is the bottleneck in a lot of the scientific progress. So there wasn’t anyone focusing on fully investigating that bottleneck: How do we actually change the law [and] open up the valve so that we can get more scientific research done?”
“If you look at the law and you look at the Oregon Health Authority’s rules to implement Measure 109, there’s no question: It’s a non-medical program. People hate it when I use this word, but it’s a supervised recreational program. …Whatever term you use to describe adult use cannabis, that’s really what Oregon is with the change that there is this supervision component, and it creates a lot of problems, to be honest. One of them is the incredible cost.”
“I think just having honest conversations is what it really comes down to, telling people that we don’t really know. ‘This mystical experience you might have: It could be a very important part of the therapeutic process or it might be kind of ancillary. We don’t really know.’ I think a lot of people do jump to conclusions, and being open-minded like you said and educating oneself [is important]. I’m constantly learning. You have to be about this. You could study for a lifetime.”
Links
Florida State University profile
Psychedelicweek.com (substack)
The New England Journal of Medicine: How Should the FDA Evaluate Psychedelic Medicine?
FDA.gov: FDA Issues First Draft Guidance on Clinical Trials with Psychedelic Drugs
Jamanetwork.com: State-Regulated Psychedelics on a Collision Course With FDA
Nature.com: Introducing psychedelics to end-of-life mental healthcare
The Harvard Gazette: Harvard launches new Study of Psychedelics in Society and Culture
Ecstaticintegration.org: Do psychedelic treatments always require psychotherapy?
