PT469 – Mason Marks, MD, JD – Drug Policy in 2023: The FDA's Guidance for Clinical Trials, The Natural Medicine Act, and SB-303
Psychedelics Today
Psychedelics Today, LLC
4.6 • 598 Ratings
🗓️ 15 December 2023
⏱️ 100 minutes
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Summary
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.
Transcript
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| 0:00.0 | In the realm of psychedelics, safety and psychological well-being takes center stage. |
| 0:04.9 | Enter Vital, our 12-month professional training delving into the diverse realms of the psychedelic |
| 0:10.2 | landscape. Here's what Vital Student and Depth Hypnosis practitioner, Vanita Watson, |
| 0:15.4 | CHT, had to say about our program. |
| 0:19.3 | And I really started thinking about safety, psychological safety, the safety of the psyche. |
| 0:26.0 | And when I saw Vital, I felt like there was a very clean energy around it. |
| 0:32.1 | I felt like it was trying to convey the reality, kind of the middle path of where we are right now. |
| 0:42.3 | And so far, I feel like that's exactly what it is. |
| 0:45.3 | We're having conversations around ethics. |
| 0:48.3 | We're having conversations around integration. |
| 0:51.3 | We're having conversations around holding space. We're having conversations |
| 0:56.3 | around our own shadow as the practitioner. I think a lot of these conversations are, no pun intended, |
| 1:03.0 | but maybe vital to the space. And I was really heartened to see that I have classmates |
| 1:10.7 | from all over the world. |
| 1:12.4 | And it's just been such a rich experience. |
| 1:18.9 | Are you working in psychedelics or taking steps to get involved? |
| 1:22.9 | Lately, we've been thinking about the future of this field, the people who are going to work with psychedelics, and how they're going to show up. So we decided to ask them, here's what |
| 1:32.8 | we heard from people in a new survey who are working in psychedelics right now or preparing |
| 1:37.5 | to launch their careers. 87.6% have been influenced by their own positive experiences with psychedelics. |
| 1:45.8 | While 47% are incorporating psychedelics into an existing career, 31.6% are switching careers |
| 1:53.5 | entirely. And not surprisingly, making money is not the goal. A staggering 98.3% of respondents indicate that making a lot of money |
| 2:03.5 | is not their primary motivation to enter the field. If you're curious to learn more about this |
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