In our latest interview, we speak with lawyer Matt Zorn about the future of psychedelics-related policy in light of the November 2024 U.S. elections.
Aside from being a Partner at Houston-based law firm Yetter Coleman, Zorn has written extensively about the intersection of drugs like cannabis and psychedelics with the law over at On Drugs.
He is no stranger to standing up to the U.S. government to challenge its drug-related laws and their application, teaming up with researchers like Sue Sisley and his colleague Shane Pennington to sue the DEA over its effective rejection of her marijuana for PTSD in veterans study, working with our Editor-at-Large Graham Pechenik to lead the successful challenge against DEA’s plan to schedule five tryptamines, and holding that same agency to task over other matters like access to psilocybin via Right to Try statute and its flouting of FOIA requests. The list goes on… and on.
But now, Zorn is bullish about the potential regulatory openings that an incoming Trump administration might present, he tells our Editor Josh Hardman. Here, he discusses the types of ‘deeper questions’ we might ask about the U.S. system of drug and medicines regulation and how we might begin to reimagine it.
Josh Hardman, Psychedelic Alpha: How do you view the incoming administration and potential regulatory openings? Are you bullish?
Matt Zorn: I think you have to be bullish, simply because the status quo isn’t that great.
Even with the status quo, I think you could make good arguments that psychedelics could get through the FDA approval process, but as we saw with MAPS/Lykos and with Compass Pathways downsizing, it’s going to be a longer process than many anticipated.
So anything that potentially accelerates that process or fundamentally starts asking deeper questions about the system, I think you have to be cautiously bullish about. When I see someone like RFK Jr., I definitely see someone who is willing to ask those questions.
With psychedelics, you can ask surface-level questions like ‘Why did MDMA not get approved?’ Or, we could start asking deeper questions, like ‘Does this approval process actually produce good outcomes generally?’
I think there are a number of different directions you can take that. You can start talking about whether the current system produces good mental health outcomes. You can ask whether it produces good outcomes when there is a deep need for something in society. And then there are epistemological questions about the very nature of psychedelics.
There’s this criticism that MDMA has spurred on “cult-like beliefs”. What’s interesting about it is that the nature of mental health conditions are often erroneous or maladaptive beliefs, and so the very nature of the way this medicine works, at least in part, is changing beliefs, right? So there’s a very problematic epistemological issue that the current FDA approval process with double-blind, placebo-controlled trials isn’t that well suited to address.
So I do think that having someone who’s a bit of a chaos agent who is willing to actually peel back the layers and start asking these deeper, more fundamental questions can only be a good thing.
If you look at the history of drug regulation and drug law, every single change in regulation seems to follow a public health crisis and the solution we come up with, it’s often the worst possible solution.
Hardman: You have actually written recently about how we could tie this incoming administration and its ‘chaos agents’, in your words, with a recent public health crisis, COVID-19, to potentially accelerate some changes. How might that work?
Zorn: It could be used. I don’t think it would necessarily be the best use. But there’s a statute on the books which was used to release vaccines and diagnostic tests before getting approval based on rigorous demonstration of safety and efficacy.
Now, you could probably use the same statute to approve adjuncts to COVID treatment or what I would call the fallout from COVID, like COVID-19 related mental illness.
There’s evidence that it would be reasonable to believe that MDMA could be used to treat COVID-19 PTSD, for example, and I think the most important part of what I just wrote is not just that it’s possible, but it’s almost unchallengeable because of a recent Supreme Court case.
With the FDA giving a thumbs down on MDMA plus the election of Trump and RFK Jr., I think it creates somewhat of a chaotic moment where we can really ask these deeper questions about drug regulation, because at the end of the day, the reason we don’t have psychedelics as medicine is mostly an economic problem.
Hardman: Right, so it’s just one example of creative thinking with regards to approval pathways for psychedelics. But the deeper point, presumably, is to poke at the standards required for approval of drugs in the U.S., no?
Zorn: Right, questions like: ‘Are we using the right standards of safety and efficacy?’ I think there’s a really good case that we shouldn’t be testing for efficacy, or that can be done post approval, or that there are ways to have medicines on the market in an off-label or no-label way while still testing for efficacy.
But then there’s also the notion that the more there’s a need in society, the more urgency there is, which calls for a different level of evidence and a different standard. (And there are statutes and laws that allow for accelerated approval or whatnot.)
So I think you can make a pretty good argument that requiring safety and efficacy for approval needs to include a third element or simply a balancing test that is more of a risk-benefit type approach. The benefit in an emergency is tremendous, and there’s an acknowledgement that if we have to wait ten years for a vaccine, the vaccine will simply have no purpose. In that case, the level of evidence we would require maybe on safety should be high, but on efficacy, probably not so much.
With the FDA giving a thumbs down on MDMA plus the election of Trump and RFK Jr., I think it creates somewhat of a chaotic moment where we can really ask these deeper questions about drug regulation, because at the end of the day, the reason we don’t have psychedelics as medicine is mostly an economic problem. A lot of people put the blame on the Controlled Substances Act, but at the end of the day, if it were more economical to bring these treatments to market, they would have been brought to market ten, twenty, thirty years ago.
Hardman: In terms of funding the necessary studies?
Zorn: Yeah. Efficacy is really hard to evaluate and it can be evaluated with double-blind placebo-controlled studies or it can be evaluated in the real world, but it can’t be evaluated in the real world when you’re making it a precondition for it to be used in the real world. So you’re kind of caught in this catch-22, where the only way to do it is with these expensive double-blind studies. And then that raises all sorts of issues about recouping costs on the backend and profitability.
Even assuming this is a successful treatment, it’s simply not economical to take the drug all the way through the process.
Hardman: So when you’re talking about FDA just taking more of a position on safety as opposed to also requiring efficacy as a precondition to getting approval, you presumably expect some effectiveness data to be collected in the post-marketing environment. Do you think the FDA should still be the one that oversees that side of things, or do you think it should be ‘the market’?
Zorn: Most people misunderstand the role of FDA, and today it’s called one of the leading public health agencies. But when it was created in 1906 and even in 1962 when the statute was amended to include evidence of efficacy, its primary mission was a consumer protection agency. We were talking about patent medicines, snake oil and whatnot, and so the purpose of these pre-marketing approval requirements was to protect against consumer deception, which is why when you look at the law, it’s about the labelling of drugs and the intended purpose.
One of the simplest reasons I believe we don’t need efficacy to be proven pre-approval today is that in 1962 you could not get on your computer and go to PubMed and get all the evidence, so you could make the case that there needed to be a centralised body to review this evidence and give a recommendation.
In the internet age, the need to have a centralised government body review all the evidence, and where AI would probably do as good of a job as FDA of reviewing these data, the case for this is severely diminished.
So I would argue that a sober rational assessment of this is that efficacy should not be required to introduce medicine to the market. I think the better argument is that there needs to be efficacy data if you’re going to put an indication on the label.
Almost certainly the insurance market is still going to want that evidence, so companies are still going to be incentivized to do it, but they could do it a lot cheaper because once the medicine’s on the market, you can start collecting real-world evidence, which I believe would be more useful in the case of mental health treatments in particular.
In this world, MDMA is already on the market.
Hardman: But aren’t many like drugs that are approved for certain indications not particularly safe in and of themselves? Obviously, everything has side effects, so they’re only deemed relatively safe in the context of the risk-benefit calculation. In your world, would the sponsor be looking to prove safety, or simply characterise the safety profile and then leave it up to prescribers, patients, payors, and other participants to decide what’s appropriate?
Zorn: Yeah, I think so. I think that if you were to require a lower standard for efficacy, that could also work too. At the end of the day, you’re kind of getting to this moral question: ‘Should the FDA be in charge of our medical system?’ And I think the answer to that question is ‘no.’ That’s not just based on morality, but also efficiency. I don’t think the top-down approach produces optimal outcomes.
Hardman: We could talk about this for days, but just so I understand your position correctly: Before FDA had these efficacy requirements in the ‘60s, people were getting hoodwinked by snake oil salesmen and so on. But you’re saying that’s less likely to happen now as there’s less information asymmetry, because people could read the studies online and so on. One concern, however, would be that the studies we read online are a very sanitised form of the data. But, in your world, other participants like payors would presumably be able to demand access to that data and do their own inspections?
Zorn: Payors, tort lawsuits… There are tons of other fields where there are products that are defective that get to market and they get sued. And I just want to be clear about the 1960s thing. I’m not saying that before 1962, it was all snake oil. In fact, the Golden Age of pharmaceuticals was from the ‘40s to the ‘60s.
Hardman: We are talking a lot about FDA approval, but many people are wondering right now whether an aligned government could just reschedule psychedelics and whether that would supersede all these issues.
Zorn: It would not. I know this with certainty because the Food, Drug and Cosmetic Act prevents any of these substances being used in the medical system absent FDA approval.
Certainly, if legislation was passed that legalised recreational cannabis then that would take precedence, but rescheduling alone does not change the Food, Drug, and Cosmetic Act. It doesn’t even make these things legal, unless you’re talking to descheduling, which is taking them entirely out of the Controlled Substances Act.
You could argue that the tax consequences would be different and I think that could make these state-level regimes financially solvent.
Hardman: On the topic of state-level psychedelics programmes, do you think that something like a Cole Memo, some kind of federal non-intervention statement regarding the systems in Oregon and Colorado, is likely to be more forthcoming with the new administration?
Zorn: A lot of folks are talking about, with RFK Jr., legalised psychedelics and cannabis, but he happens to be in the wrong agency for that one. That would be more on the attorney general side of things.
Hardman: Which is Pam Bondi, and she’s been somewhat anti-marijuana, right?
Zorn: It’s hard to tell. And I think there’s every indication that Trump’s not going to tolerate people deviating from his position, so it depends on what stance he takes.
Hardman: To what extent do you think psychedelics advocates should be watching marijuana rescheduling closely, and how much of an impact do you think it would have on psychedelic policy reforms?
Zorn: Extremely closely. If you are at all interested in rescheduling, this is the highest profile, most impactful rescheduling that has ever occurred.
Hardman: You’ve spoken in the past about how the opposition to these reforms, like Kevin Sabet’s Smart Approaches to Marijuana (which is also successfully opposing psychedelic policy reforms), is very successful with quite a modest budget and headcount. And I know you’ve also criticised the marijuana industry for not being more organised when it comes to pushing for regulatory changes. How much money do you think it would take and how organised would the psychedelics field would need to be to start thinking about and pushing for some of these more fundamental changes? What would you like to see happen?
Zorn: The folks against us, they have the high ground. They have the home-court advantage because they’re not trying to change anything.
First of all, they’re good. They know their stuff, they know the laws and they have these relationships and whatnot. In psychedelics, we are starting to do that, but it takes time to build those connections. So again, it’s easy to be critical of one side or the other, but I think it’s instructive to understand why it is they have very good success with potentially fewer resources and it’s not just because of the advantage or whatnot, I think they understand the laws, they understand the strictures, and they’re very strategic about what they’re doing. They’re obviously very good at piloting certain narratives, many of which I agree with.
I think with psychedelics it’s a little less strategic and a little more guided by emotions in terms of trying to come up with short-term solutions instead of attacking the deeper structural issues.
One of the areas that I’ve worked on is religious use, which is a place where that high ground is actually a pretty even playing field. It’s a good place to do battle.
And I support clinical trial reform wholeheartedly and other reforms, but if you are going to go the FDA path, when in Rome, do as the Romans do. I think that was the problem with the MDMA-assisted therapy. We can complain that the rules of this game are unfair, but if you’re going to play that game, you have to play by the rules. Or alternatively, change the rules.
It’s important not to push too far at the state level without federal support. The interesting thing is, even when drug policy is favourable, it’s not terribly salient. It’s a fickle thing where you can maybe get votes for your side, but nobody’s really passionate about it.
Hardman: As we saw in the recent elections, the drug policy reform appetite pendulum among the public seems to be swinging back towards prohibition. In order to be successful in the types of changes you’re imagining, who do you think you and the field need to convince?
Zorn: I think that’s why it’s important not to push too far at the state level without federal support. The interesting thing is, even when drug policy is favourable, it’s not terribly salient. It’s a fickle thing where you can maybe get votes for your side, but nobody’s really passionate about it.
One thing I’ve been talking about is, rather than trying to bring people to psychedelics or bring psychedelics to them, I think a lot of it is about illustrating that psychedelics have already contributed to our culture. Take Watson and Crick: one of them was apparently on LSD when theorising the double helix structure of DNA. (Editor’s note: Crick’s biographer, Matt Ridley, reported that the scientist dabbled in marijuana and LSD, but the drug’s role in the DNA story is unclear, and perhaps unlikely.) There’s a less dramatic case for psychedelics too, right? What about ‘psychedelics help me with bowling?’
Hardman: I have been speaking to a lot of people in the field about this incoming administration. Some tell me that it will help the psychedelics drug developers, who are usually trying to get patented forms of psychedelics to market, through deregulation or psychedelics-specific concessions. Others say that the administration will be more interested in bringing generic forms to market (whether through the FDA or policy reforms), what with RFK Jr. being prominently anti-pharma. What do you think?
Zorn: I’m kind of skeptical. There’s a lot of stuff that could be done that frankly is being done now at the FTC with the Orange Book, policing listings. That’s not really an HHS thing, it’s such a massive undertaking that would require multiple agencies working in tandem and potentially Congress to reform the way patent laws are written and so on.
Hardman: On the FTC front, do you not think that if you slim down efficacy requirements at the FDA, a lot of that responsibility would then be palmed off to the FTC in terms of regulating the claims that companies make around their drug products?
Zorn: Maybe. Or, like antitrust, it could be enforced at the state and federal levels. I think that, yes, it would become a little bit more consumer protection, but I don’t know if it’s necessarily on FTC’s docket tremendously.
Hardman: My last question: What do you think will happen in the DOI and DOC case?
Zorn: It sounds like the ALJ has held a pretty fair hearing, and it sounds like there’s not that much evidence of abuse. But, it’s very tough to beat the DEA in these courts: they get every benefit of the doubt at every step of the way, they made all the rules, and here’s the bottom line… at the end of the day, even the ALJ can come out with one decision, and the administrator can decide differently.
It’s hard to say, but kudos to the folks who went and did that. I think that that’s going to be very important too for psychedelics.
