Regulations
PT435 – The Federal Right to Try Act, The Farm Bill, and the Constant Balance Between Risk and Regulation
August 25, 2023
Featuring: Satya Thallam
In this episode, Joe interviews Satya Thallam: Policy Advisor at the international law firm, Arnold & Porter; and longtime policy expert based in Washington, D.C. who previously served in senior roles at both the White House and the U.S. Senate.
In this episode, Joe interviews Satya Thallam: Policy Advisor at the international law firm, Arnold & Porter; and longtime policy expert based in Washington, D.C. who previously served in senior roles at both the White House and the U.S. Senate.
Thallam was the lead author and negotiator of the Federal Right to Try Act, which grants terminally ill patients access to experimental therapies and substances that have completed Phase I testing but have not yet been approved by the FDA. He discusses its intricacies and benefits, how psychedelics were not a focus but were always obvious, whether or not it allows people to grow their own mushrooms, and more. He talks abut the implementation of the first Federal legalization of hemp under the Farm Bill in 2018, breaking down the history and detail of how it came to be, and why a difference of .3% in weight truly matters when establishing law.
He discusses the changing landscape of politicians and psychedelics; how local action creates a culture of inspiring Washington; the internal fight between different agencies and the endless lobbying it takes to get things done; how one needs to cater their argument by who is listening; risk assessment and judgment-proof operations; the concern over whether or not we got everything wrong with cannabis; and why we will likely begin seeing a lot of coalitions popping up in the psychedelic space.
Notable Quotes
“All of this, even just the traditional FDA regulatory rubric, is about a trade-off between type one and type two errors. And you can set policy in such a way that there’s 0% chance of any harm, but then you forgo any possible benefits from that. There is no drug anywhere that has 0% risk. Even Advil has risk, right? It’s all about dosage, it’s all about use, it’s about other conditions that you may have, it’s about tailoring it to the appropriate indication. …We make these trade-offs all the time, and I just happen to fall more in the camp that a greater degree of those trade-offs should be at an individual level to the degree possible than establishing a macro floor or ceiling that people have to respond to, because you may forego some incredible benefits like we’re seeing – especially in some of the psychedelics here.”
“I’m reminded of that Simpsons episode where Homer just says: ‘When will people learn democracy just doesn’t work?’ Like, this is the necessary mess of democratic institutions, right? They’re not structured to listen to the single smartest person in the room. That’s by design. That’s a feature, not a bug. But it also means progress can be slow, slower than we want it to be. …I’m newish. I’m sort of a noob to the psychedelics community, but I’m not new to policy. I think the folks that you talk to that are in your circle, that listen to this show, should be pretty encouraged. I think overwhelmingly, things are going in the direction that you would want them to.”
Links
Arnoldporter.com: Satya Thallam
Politico.com: K Street warms up to psychedelics
