"Balancing Medical Promise and Regulatory Complexity in the Psychedelics Landscape" The "Psychedelics Capital Podcast" host Ross O'Brien from Bonaventure Equity interviews Michael Werner from Holland & Knight, discussing the regulatory landscape for psychedelics. Michael, a partner at the law firm, explains that while the FDA sees itself as a public health agency focused on ensuring safe and effective products, the DEA approaches controlled substances like psychedelics from a law enforcement perspective due to their potential dangers. He highlights that while many drugs, including psychedelics, have potential benefits, the FDA emphasizes the importance of rigorous clinical trials to establish their safety and efficacy, particularly in a landscape where recreational and unregulated use is also prevalent. Produced by PodConx
"Balancing Medical Promise and Regulatory Complexity in the Psychedelics Landscape"
The "Psychedelics Capital Podcast" host Ross O'Brien from Bonaventure Equity interviews Michael Werner from Holland & Knight, discussing the regulatory landscape for psychedelics. Michael, a partner at the law firm, explains that while the FDA sees itself as a public health agency focused on ensuring safe and effective products, the DEA approaches controlled substances like psychedelics from a law enforcement perspective due to their potential dangers. He highlights that while many drugs, including psychedelics, have potential benefits, the FDA emphasizes the importance of rigorous clinical trials to establish their safety and efficacy, particularly in a landscape where recreational and unregulated use is also prevalent.
Ross O'Brien - https://www.linkedin.com/in/rossobrien/
Bonaventure Equity - https://link.bve.vc/Visit-Us
Michael Warner - https://www.linkedin.com/in/michael-werner-a402189/
Holland & Knight - https://www.hklaw.com/
Welcome to another episode of the Psychedelics Capital Podcast.
I'm your host, Ross O'Brien, venture capitalist author and all things frontier, new Frontier Healthcare related. That was stupid. I. I should probably get this down as a, like a [00:55:00] standard one. Wing it every time. Don't you do this all the time? I, I do, but keep forgetting what I say. I guess I better go back again.
Welcome to another episode of Psychedelics Capital, the podcast. I'm your host, Ross O'Brien, founder of Venture Capital Fund, Bonaventure, equity author and lifelong entrepreneur. Uh, I'm very excited to have another I. Very informative episode with you today, uh, with Michael Warner from Holland and Knight.
Uh, get out your notepads and your pens. Uh, this is a really, uh, really exciting and detailed conversation. You're gonna learn a lot about the F d A, the d e a reimbursement new landscape for, uh, psychedelics and cannabis. So with that, I'd like to welcome to the podcast Michael Werner. Welcome Michael.
Thanks, Ross. Great to be here.
So Michael's a partner at Holland Knight out of their Washington d c office. Uh, and we talk a lot about things like f d A and d e a and what's happening in this, uh, new world of psychedelics.
Um, and so I think the place to start, Michael would be, um, you know, we've just heard some. Some news coming outta the f d a. And you wrote a really interesting piece on some perspectives with [00:01:00] the f d a issuing guidance on, uh, on, on clinical trials and studies for psychedelics. So it seems like, um, this is here to stay.
The regulatory agencies are, uh, certainly intrigued with the potential for psychedelics as treatments. And so maybe the place to start would be tell us a little bit about your practice, um, your exposure to these emerging. Uh, I ideas and concepts and, and let's dig into it. Sure. So, um, I am a partner at Holiday Night based in Washington d c um, and I've been with the firm about 15 years now.
I head up our F d A practice and I'm one of the leaders of our national healthcare and life sciences team. Um, I've spent a lot of my career. Working with, uh, product developers in new technologies, particularly in new life sciences technologies. And whether that's cell and gene therapy and [00:02:00] regenerative medicine technologies or technologies, um, that's where.
That's, that's, that's kind of my bread and butter. And those are the, the people I tend to work with, the entrepreneurs I tend to work with. And now, of course, uh, working in the fields of, uh, psychedelics and cannabis and. Um, in every case it's, it's kind of the same, which is to say, how do we, from a policy perspective, how do we, um, create a regulatory environment that is conducive to product development?
And by that I mean, The development of safe and effective products for patients. And then, um, how do we make sure there's, uh, of course a reimbursement system that appropriately, um, pays for those products. And then when we're thinking about individual companies or product developers or researchers, [00:03:00] uh, the issues tend to be.
What do the regulatory agencies wanna see? How do you actually put together your clinical program? How do you design your trials? Um, how do you bring your product to the market for that matter, right? Just how do you bring your product to the market and then keep it on the market because you're complying with.
Uh, the FDA's rules about, um, products post-marketing. So those have been the topics that I've been working on for the better part of two and a half decades with lots of businesses and lots of companies. And, uh, it's exciting to be working in the psychedelic space. Well, thanks for that background. This is really, um, gonna be a great conversation.
I hope everybody's got a pen and paper. I always learn a lot from our discussions, Michael. So I think, um, what would be helpful is maybe can you give us a little bit of a crash course on the F d A, the role of the F D A, how the F D A looks at these in particular [00:04:00] new technologies, um, going back historically and what sort of precedents are being set.
So for, you know, a lot of our audience or founders and entrepreneurs, how should they be thinking about stepping into this landscape with a baseline of sort of how the, how. D and the policy landscape works well. I think that when you're thinking about the F D A, and if you are getting into this space, you are going to be working with the F D A sort of period, full stop.
And if you're working with the F D A, I think it's important to remember. A couple of important things. The first is that the f d A very much sees itself, uh, and I would say appropriately sees itself as a public health agency, that their mission is to protect the public. I. Uh, to make sure. And they do that by making sure that products for, um, a variety of illnesses or [00:05:00] disabilities or disorders or conditions are safe and effective.
And we're talking about drugs now. Not, not their, not food, though. The broader concept is the same. By that I mean, The F d A sees itself as the protector of, uh, the public. That to make sure that your food isn't contaminated, to make sure that your, the drugs you take, the medicines you take are safe and effective, all of those things.
And they also see themselves as a science-based agency. Many, many, many, if not all of the people at the F D a, particularly, the people who are going to be reviewing. The data from, for example, clinical trials are scientists by training, and so they think of themselves as applying the best science to protect the public health.
[00:06:00] So I think it's important for you to think of it that way because when you're approaching the agency or developing your program, that's the lens that they're gonna be looking. That, that's the lens they look through when they're talking to you or when they're looking at your data. Right? That's what they wanna see.
By the way, they also think, um, that there's no reason that entrepreneurs and companies and the agency can't work together toward that goal. Right. And in fact, in my experience, the companies. Uh, uh, whether they be in cell and gene therapy or digital health, or you name it, or pharmaceuticals. The companies that have the most success are the companies that actually don't see the F D A as their adversary, but they see them as having the same goal, which is.
We wanna get a [00:07:00] safe and effective product to patients as soon as possible. And if you look at the agency that way, that's also, uh, tends to make your interactions with them much more productive. So that's the first thing. Just in general about, about dealing with the F D A. Now, the d. Um, as Ross you mentioned has recently issued a draft guidance for, uh, the development of drug, of, of psychedelic drugs, and this is an incredibly important and positive step forward in this field.
Why? Because what it means is that F D A recognizes the power of these kinds of medicines to treat. Unmet medical needs, right? P T S D, uh, [00:08:00] uh, treatment resistant depression, kind of a lot of mental health, um, illnesses and conditions. And by putting out, by putting out and publishing this draft guidance, what F D A is saying is we recognize this.
We recognize that there's a real need for these products. What we're doing in this guidance is we're telling you our thoughts about how you as a drug developer should think about your program in order to demonstrate to us that your product is safe and effective. So basically, one way to think about this is that it's an attempt by the F D A.
To take some of the guesswork out, right? There's always a little bit of guesswork when a company is thinking about developing a drug and there's always a little bit of guesswork about the science, and there's guesswork about how patients are gonna [00:09:00] respond, and then there's guesswork about what the agency wants, right?
What do they wanna see? How should we design this trial? What should our end points be? So what the agency does by publishing guidances, like the draft they did this summer, is they're trying. Trying to take some of that mystery out, at least from their perspective, by signaling what they want or at least signaling what they're concerned about, that they want you as a drug developer to be thinking about as you put together your program.
Guidances are not law, right? It's not a regulation. Nothing in this draft guidance is a. But it does represent the agency's most current thinking about the technology and about these products. So it is always wise to be reading it very carefully [00:10:00] and thinking about how you can apply these concepts or perhaps incorporate them into your clinical program.
Now, one thing that's interesting about psychedelics that F D A talks about, Is of course that the d e a is involved, right? That's not, that's not always true if you're developing a drug, right? But in this case, it is true, right? You might be talking about a Schedule one drug, and if the d e A is involved, The D E A sees itself very differently than the F D A does.
The d e A sees itself as a law enforcement agency, right? We've all seen the movies. We've all seen the TV shows. They've got guns, they wear the [00:11:00] jackets, they kick the door down. They go get bad guys. That's what the D E A does. That's how they think of themselves. So in the context of psychedelics, the D'S perspective is very different than the FDA's perspective.
The D'S perspective is you are doing research on something that we think is a dangerous drug, and because of that, We are worried about things like diversion of this drug, um, so that, you know, bad guys are gonna get it and then. People are gonna get hurt. So what that means is that if you are working with, um, many of these compounds and their Schedule one drugs, that means you are gonna have to navigate d e a regulations as well as F D A regulations [00:12:00] and the D.
Regulates manufacturing. They regulate transportation, they regulate handling, they represent storage and record keeping. All of those things are gonna have to be a part of your program because you are, by definition, dealing with a d e, A regulated drug. So you're gonna need probably a D E A license and you're gonna need to follow d e a rules.
Like I said about handling storage, transportation, all of that kind of stuff in order to do the research on your psychedelic, why don't I stop there, Rob? I think that's fantastic. Um, It's really interesting to sort of unpackage these two disparate frameworks, and I'd like to explore a little bit where they overlap.
Right. So, uh, you know, and to, to, to recap as I'm hearing you describe it like this de a's public [00:13:00] service is to, uh, prevent scheduled substances from getting into the illicit market and as a danger to, you know, uh, to the population. F D A is looking at. Uh, new technologies, new chemistries, new compounds, new molecules, and if they are going to be consumed in a pharmaceutical or as a nutraceutical right, that also falls under.
F d a guidelines. Mm-hmm. For, for nutraceuticals, I'd like to Yeah. Come back to that. Yeah. Um, that it should be safe and quality and efficacious, et cetera. Um, now controlled substances though, are, they play a role in healthcare across the whole healthcare spectrum. Right. I think morphine schedule three or Schedule two or Schedule three.
How do you think about scheduled substances? Uh, is it really just that this is a highly controlled, regulated place to be in, in the, you know, healthcare arena or, or are there more complexities to it than that? [00:14:00] Um, I guess I would answer that question by saying, Uh, you are a hundred percent right. There are lots of controlled substances, um, that are, that have f d a approval that are developed and marketed and sold, and people use them all the time, right?
I mean, you don't, morphine is one, but you could look at. You know, uh, um, anything with methylphenidate in it, right? You know, Adderall or any of these kinds of drugs, all are controlled, have controlled substances in them. So it's not, it's not, um, a deal breaker by any stretch of the imagination. Now, with psychedelics, you may be dealing with a schedule one drug.
Um, which is the most, from the DE's perspective, sort of the most dangerous. Um, but it just means that you have to comply with a separate set of rules in the same way. [00:15:00] Like I said, any drug company that you know, makes morphine or any drug company that makes any derivative of Ritalin, um, Has to comply also with D E A rules about storage and handling and record keeping and all of the things that I.
Talked about. So it's 100% part of our, of our, um, landscape. There's lots of drugs that come to the market having to comply with both of those regulatory frameworks. I. It is just that in the psychedelic space, number one, you have, you just, people need to know you're gonna have to do it. And number two, you are probably gonna, d e a might even look a little more carefully because it's uh, they may consider something like psilocybin to be a Schedule one drug.
So, Again, you'll need to apply for a D E A license. And in that process you'll have to demonstrate how you're gonna store the products, where [00:16:00] you're gonna get them from, how you're gonna make sure there's no diversion, you know, your supply chain, all that kind of stuff. But then like right once, once you have all that.
Then you're now, you know, just purely an f d A world and you're gonna follow the F D A rules around performing a clinical trial. One of the things that F D A talks about in this guidance, the, the D E A rules are just one piece. I mean, the f d A does say that, you know, uh, the standards of approval for a psychedelic drug are the same as every other drug.
But they do talk about the quote that they use is unusual characteristics that merit special consideration, right? So they do, they do talk about the fact that, hey, we're talking about drugs that might cause, you know, again, I'm quoting intense [00:17:00] perceptual disturbance and alterations in consciousness. Um, you know, that can last for several hours.
So, Again, F d A is saying we think these drugs have promise. We think they can do a lot of good for a lot of people, but we, we f d a want to acknowledge or want you as a developer to acknowledge that these drugs are also a little bit different than the run of the mill pill and they have particular properties that that could cause people some vulnerability.
So again, if we think about them as protecting the public health, your attitude is, okay, so we've got vulnerable people. These are really powerful drugs, and we're still learning about what they actually do and how they work. So we're gonna say, you know, we wanna see how you as a [00:18:00] drug developer are gonna manage all of these issues in a clinical trial setting.
So from personal experience, I can say they've got it right. Um, they can last for hours and have epi effects. Um, and I think a lot of people, uh, you know, are acknowledging that and we're seeing. Um, you know, a lot of, uh, you know, shaman experiences of opening up and people going on journeys and going to other countries and things, and there seems to be this groundswell of just rec recreational use, for lack of a better term.
I mean, people view it as a, you know, as a medicine or medicinal as a naturally occurring, um, you know, fungus. So where is the intersection between. Naturally occurring nutraceuticals, uh, F D a, all the way through the spectrum to, you know, approve drugs. Um, and, and are those unique characteristics to [00:19:00] psychedelics that there is this sort of advocacy space?
Have you seen that in other sectors before? Are people sort of using it recreationally as well as trying to conduct, you know, real scientific research? So, um, we definitely see it in other places. Um, I, I mean, I would argue you see it in the cannabis and c b d space. Mm-hmm. Um, but you see it elsewhere as well.
But these kinds of, Pose real challenges to the agency, to the F D A Because of what I said. They really think that the way to make sure people are getting safe products is for them to be proven safe in a controlled experiment, which is what a clinical trial is. And they, uh, they get nervous [00:20:00] about, um, when that doesn't happen and they get nervous because they feel like, where's the quality control?
Right. How do we know what people are actually, I. You know, taking smoking, you know, whatever. Right. Um, we don't, we don't know where it came from. We don't know what's in it. We don't know, you know, if there's been any issues with it. Right. Um, we don't know if, uh, you know, the crop was, uh, sprayed with pesticides or something.
Right. We don't know anything. And so the f d A gets really nervous about that and, um, And, and so they really try to encourage the use of the scientific method, right? Clinical trials demonstrate that your product is safe. I think that, um, f d A is, is, um, well, I'll say it this way. [00:21:00] Part of the issue here is that, um, When people use a product recreationally, there is this potential danger.
F D A knows it exists, right? I mean, of course they do. Of course we all do. Um, but what they wanna see is we wanna see people taking this product. That's been proven to be safe and by the way, proven to treat these healthcare conditions, right? So it's not just that it's safe, it's that if you've got treatment resistant depression, we've, this product can work for you.
Right. Hopefully. Right. Or, uh, if you've got P t Ss D, this product can work for you. It's not, they're not in the business of, Hey, take this, you [00:22:00] know, it's a great feeling and you know, you'll, you'll, it's a wonderful experience for you and your friends or what have you. They're thinking about it in a medicinal context.
Mm-hmm. Right. How do we make sure that people. Who have these conditions that they can't, therapy alone isn't working. The other products on the market aren't working. People are suffering. How do we get products to them as quickly as we can? And so they put out guidance like this to try to speed that process along.
So that's interesting. Talk to us a little bit about, um, or can you speak to a little bit about speed in the process, right. Generally. So if somebody's conducting scientific research and they think they have an application, um, that they want to pursue an f d a approval for, what is the general. Sort of timeline [00:23:00] costs, and then everybody, you know, the one case study that we have is Epidiolex right in Yeah.
In, um, cannabis for, and yeah, that was my understanding was that was quote unquote fast tracked, which is a specific term, right. A specific process within the fda. Yep. Um, largely because it was for an adolescent form of epilepsy that can be fatal and there's no alternative on the market, right? Mm-hmm. So children are dying.
There's no. You know, the, there's no, there's nothing they can take. So we need to speed up this, this process in that application. Now, it also would seem that that is rare or probably something that we should certainly shouldn't expect to be just replicated over and over again because it's a cannabis-based, um, product, right?
Yeah. So, um, generally speaking, The f d a process is long. Um, it takes a long time to [00:24:00] put together a trial to give patients a, a product to follow 'em, uh, follow those patients over a period of time to record all your data, to submit all your data to negotiate, and, you know, It's very methodical. The first phase tends to be just about safety.
The next phase, you add a few more patients and you start talking about efficacy. Then finally, you start adding a lot of patients. You can talk about safety and efficacy. It can take a long time. It can talk, depending on the product, can take certainly tens of millions of dollars, maybe more, right? There's some products that stake hundreds of millions of dollars.
F D A, um, Well, I'll say that that's a problem, right? That's a problem. That's not just a problem for, um, psychedelics cannabis or psychedelic. Yeah. That's problem much more broadly and in recognition of that problem, Congress [00:25:00] and the F D A have developed. Certain what they refer to as expedited pathways to market, all with the idea of speeding the time from when, uh, you go to the f d A with your idea and your molecules to when you actually get.
Hopefully an approval. And, um, you, uh, fast Track is one such program. It's a specific program. Another is Breakthrough Therapy, also a very specific program. And in order to qualify for those programs, there are very particular requirements spelled out in law. And in guidance, there's also something called accelerated approval, which is also spelled out in law.
All of them tend to focus on what you said, Ross, which is all of them tend to focus [00:26:00] on. Um, conditions for which patients that are serious, uh, often that are life-threatening, though not necessarily, but for which there is no alternative treatment or no satisfactory alternative treatment. The idea being just what?
You know, you would intuit like, Hey, there's already, um, a drug for asthma on the market. That works just fine if you've got a new drug for asthma. Unless you can show that you're filling a niche that isn't filled, you, uh, go through the regular order. But if you are talking about right, like an Epidiolex case, a treatment for a childhood epilepsy, um, Um, back in the day, certainly if you were talking about treatments for hiv aids, and I would argue, you know, treatment resistant depression, by definition we're talking about a, a condition for which [00:27:00] current treatment doesn't work.
Um, I think those are probably gonna be options. Now, what you probably will see in this space, which. Is not uncommon for the reasons I just went through is that the first products to market tend to be for, um, diseases or conditions like that where they're very serious or they're life-threatening and there's no alternative treatment on the market, and it's not unusual in all disease indications or in many disease indications that that's where the first products come to market.
For the reasons we're talking about because they can get to the market more quickly and so they become popular with drug developers or investors and so, and patients for that matter. And so they come to the market more quickly. And what tends to happen is once those products come to the market, [00:28:00] f D A starts to.
Now have a much bigger database about, in our case, psychedelic drugs and how they work and how they work over the long term, right? Because now we're out of a clinical trial, we're onto the market where lots of people are taking the drug, and now there's a lot more data about how it works and when it works and what it needs to work.
So now, Potential drug developers, on the one hand, may not have access to an expedited approval program, but what they do have is an F D A that's much more confident and much more aware about the data behind these kinds of products. So almost by definition, that regulatory pathway to market is now a lot smoother and faster than it was.
Previously [00:29:00] and what I've described that kind of cycle that I've described, we've seen play out many, many times in for lots of, um, indications for rare diseases, for example, and, and lots of other things. And I would anticipate that's what would happen here as well. And so where do you see, do you see, or how will this play out with a, um, I, I'm referring to as a recreational market for.
Um, psychedelics, right? So in. You know, Oregon, for example, right? Giving out licenses. I, I, I believe, and correct me if I'm wrong, but I believe they're cautiously licensing and, and not sort of rushing into it like they did, like everybody sort of did cannabis, right? Um, but at some point there's a, there's certainly a groundswell of of interest in, you know, putting psychedelics in chocolate bars and making them available, you know, in dispensaries and.
Different cities. Right? Like [00:30:00] where does that play out? That's a great question. Um, I don't think that any regulatory agency is, can stop that. Um, there might be some states that don't allow it, I suppose, but I don't, I don't know that federal agencies can. Um, can stop it. I mean, they can legally, um, just like they can for C B D, but they don't, and I, I, I don't think you can stop it.
I think what you would be more likely to see is. Federal agencies regulating or, or kind of going after people who say that, uh, make claims about their product. So for example, if, uh, M D M A or one of the products that comes forward, you know, to treat, you know, treatment resistant depression, let's [00:31:00] say, uh, gets approved by the F D A and then.
People wanna sell, uh, a bar at a, at a, you know, whatever dispensary, uh, and says, yeah, we've got psychedelics in here, or we've got, you know, M D M A in here, or we've got whatever. And you know, it can help you with your depression. Well, I think then you might see the F D A say, wait, wait, wait. There is a drug on the market for depression with a psychedelic that's not this.
So you might see them at that time, take some kind of action. You might see them even before that, like they have done with cannabis. If, uh, somebody is really brazen about the claims they make about their psychedelic product and all of the. Things it can do for people. Um, you might see them take some enforcement action there [00:32:00] as well.
I think that other than that, I think it's gonna be really difficult. Now the challenge is going to be for those who wanna see that market develop, I think. One, we are gonna see these products coming to market through the f d A, so the f d A might be more willing to take action. Two, you might have the companies that develop the product through the F D A, uh, kind of help go after these other, uh, places.
And three, I would argue that when you're talking about psychedelics, you are talking about. I don't know if you know, we all wanna say they're all dangerous, but you are talking about powerful drugs. Um, and I think that there really could be a public health argument that might [00:33:00] put the brakes on. I don't know if it stopped, but kind of puts the brakes on some of these recreational.
Uses, um, before it, we have a situation like we have with cannabis. Um, it'll, it'll be interesting to watch, but I, I think we're talking about different, we're talking about different drugs, um, that can have different, uh, impacts on people. And so I, I, that may, that may come into play here and so, One of the things I'm interested in, and some of the things that we're actually working on is how the regulatory landscape keeps up with this, right?
So I, I like how we frame this. You framed this early on. These are new technologies, new discoveries. There's precedence for this across healthcare, throughout the history of, you know, science and innovation, right? Um, It seems to me like we [00:34:00] are still trying to figure out the answer to questions like, okay, cannabis or psychedelics are legal in a certain state, but wait, people are driving on these things, so now what do we do?
Right. And so how do, how does, how do you see the. Overall reg regulatory landscape adapting to, you know, it seems to be a lot driven by advocacy, right? So now these things start happening, but the regulations need to be a lot more comprehensive than just access. Am I thinking about that the right way? Oh, I think you are.
Um, I think it's what you said a few minutes ago that. Um, as often happens, right? The world is far outpacing the regulatory system, which is scrambling to catch up. And, um, I think that, um, it, it, it really is related to your previous question because it's also number one. [00:35:00] Um, it's, you know, even we're talking about cannabis, right?
And then, you know, are there gonna be issues about driving say, and, and other things like that. And then psychedelics, I think we have to be careful about, um, sort of, let's say applying the state model for cannabis, right? They're, that's why I'm saying they're very different. I mean, the, the sort of. You know, I Philoso philosophy maybe, or the advocacy or, or all of that is similar, but the products are really different and, um, I think that, um, we just have to be careful before we try sort of a one size fits all approach, especially in the, when we see with cannabis that I think people are now realizing.
Okay, well maybe we need access. Okay, but we also need to [00:36:00] regulate this stuff more than that, right? I mean, like maybe we need to regulate supply chain. Maybe we need to regulate, I. Labeling and ingredients and all that other stuff. And so I think it's gets, I think it gets complicated pretty fast. Um, and um, I think if, if I were sort of getting into this space, look, I think you have to kind of watch it of course, but it seems to me that.
This is an area that the federal government is gonna get their hands around. Ironically, they may get their hands around psychedelics before cannabis. Um, you know, I would anticipate on the cannabis side, like, you know, the F d A, just. Well, working with Congress, they just asked for stakeholders to submit ideas about [00:37:00] regulation of cannabis as a supplement and a food, which, which lets you know that the F d A kind of threw up their hands a bit.
Um, and I would bet that they're gonna try to not let that happen with psychedelics. So they'll try to get out in front of it a little bit more. So that's, that's really interesting. Let's talk a little bit about, uh, food ingredients. Um, it feels to me like. And I agree with you. Look, this is going to be a lot more complicated.
There's a lot more regulation to come. We're going to need it. I'm one of these pro-regulation people, right? Our participants in this space, largely because it seems just sophomore to me that so many I. People get caught up in the sort of advocacy momentum of, you know, the legalize IT movements and things and as if that's the destination, right?
So that to me feels like that's the starting point. So now we've accepted in our communities that we want to have access to these things. Well, how do we go do [00:38:00] that? Right? And I certainly hope that they don't just try to. Cut and paste, um, what's been done in cannabis because I, I don't think anybody would agree that it's been done really well across the board, but it certainly created some momentum that I think could be very positive and built upon now.
But a lot of it seems to be stemming now from sort of loopholes in, you know, the Delta eight, Delta nine stuff and the farm bill. Right. And, you know, at what point do those things get. Closed down. And so what does that mean when you said the f d A kind of threw up their hands and, and thinking about, and I'm assuming this is largely focused on C B D and C B D being a, you know, an, an ingredient in beverages and things or, you know, gummies or whatever it might be, or sleep aids, et cetera.
Yeah. Um, so, so how does, how does the f d A look at that? How do you, how do you sort of see that playing out? Because clearly it's got. Some benefit, but you know, I, I can't find any toxicity testing that [00:39:00] shows that this stuff is safe. Right. So part of the challenge here, um, is that, uh, of course, well there's two, two issues, right?
One is that the way f d a regulates food and supplements is different than the way they regulate drugs. Um, so there's no pre-market approval, for example, for a supplement or food like there is for a drug. So can you just explain that, what that, the, what that means? Well, sure. Like we're talking about drugs and we've been talking about clinical trials to demonstrate safety and efficacy.
Um, if you are selling a, a supplement or a food, you don't have to. Do that. Mm-hmm. You don't have to do trials, you don't have to, you don't have to do that. Um, now, but you also can't claim that it has that, okay. Yes. No, that's exactly right. You can't claim that it has medicinal effect. You can't say it's to treat, prevent, or diagnose [00:40:00] an illness or a disease or a condition.
Um, Now, you know, um, so in theory for the C B D side, you can't market A C B D. Um, You know, lotion and say, this will, this is great. And treats your arthritis right. You can't do that right, because it's on a drug you didn't go through, unless you went through clinical trials to prove that it treats your arthritis.
And most of the time, and, and, and successfully through clinical trials, not just do them, you have to come out the other side with real. Yeah. Um, now what you do have, what you must do, however, Before you can market a dietary supplement is your dietary supplement. Can't have what's referred to as a new dietary ingredient, which basically means a dietary ingredient that wasn't on the market, um, uh, before the law was [00:41:00] passed in 1994.
And so there is a process by which you notify the F D A. That, Hey, I've got this supplement and, um, it contains this ingredient and, um, here's why I'm using it. Here's how it's been used. Here's why I think that it's safe. F d a usually just lets it go. And if they, you don't hear from them in 75 days, you market your product.
D. Well, wait a minute. You know, show us more data, right? Or, we've got some concerns about this. And, um, what's happened is with That's one. I'm sorry. That's one thing. The second thing is that by law, F D A cannot allow a, a dietary supplement on the market with a dietary [00:42:00] ingredient that is also the active ingredient in an approved drug.
Or in a drug that's in a clinical trial. Can you give us an example out of another Epidiolex is the example, right? So that's why F D A can't approve C B, D as a, um, in a food or in a supplement because it's an active ingredient in an approved drug. So that's what the Food Drug Cosmetic Act says, that that's law.
So what F d A has been saying is, Hey, we get it. You wanna put, put these, um, cannabinoids, um, in foods and supplements? We can't let you do that because the law says we can't. So Congress, you need to change the law. So Congress says to f d A, okay, well think about changing the [00:43:00] law. Wha how should we do that?
Like, what do you think the guardrails should be for when this would be allowed for, uh, cannabinoids like C, B, D, right? Like it should always be true that even if it's in a drug, you can do it. Because you, f d a have been saying for a long time, we don't think there's a medicinal purpose for C B D, right?
So what do you want us to do? So f d A has been wrestling with this part of their wrestling is, okay, we know that people are doing this, so how can we create a regulatory framework? That allows people access to supplements or food with C b D in it, but not [00:44:00] carte blanche, but like says, yeah, but we're gonna make you do 1, 2, 3, and four if you're the manufacturer of that product.
And it's that, that they kicked back to Congress and said, we need help from stakeholders. To help us figure out how to do that. So where we are is that Congress issued this request for information, sort of on behalf of the F D A and said, Hey, um, tell us what you think. And so people have been, I believe the.
Period for commenting is closed. But people submitted comments. So what this means is all of these comments and all of these ideas were submitted to Congress. So what this means is that this fall Congress is gonna. [00:45:00] Legislate on C B D in food or dietary supplements. I wanna be very careful to everybody who's listening here.
I did not say that they're going to enact legislation, right? I said they're going to legislate. There is going to be. Congressional hearing, there is going to be Congress saying, well, here's what we heard. You know, why don't we try this? And people will comment. There'll be opportunities for input. There'll be opportunities to lobby Congress.
The f d A is gonna have input, undoubtedly, the F D A is gonna work directly with Congress on this, but the point is for people who've been waiting for action. From the F D A I think you're gonna start seeing it this fall. Wow. This is so informative and I just love how, um, clear, uh, [00:46:00] you explain everything.
Michael. Uh, uh, I have one more question. You know, before we wrap up, we're gonna have to do this again for sure. Um, can you talk a little bit about, just in a separate topic that we mentioned earlier on. Um, reimbursement, uh, the role reimbursement plays, how important it is, and how, how will reimbursement need to, um, take shape in order it specifically around psychedelics?
Yeah, so that's a really good question that I think is only now kind of surfacing as, uh, a topic for consideration. And the challenge is going to be that for many psychedelics, um, mental health providers are gonna be involved. They're gonna be involved at the clinical trial stage. They'll be involved when the product comes to the market.
And you're talking about talk therapy, right? It's, [00:47:00] yeah. The practitioners and, okay. Sure. And or that, um, The product may be administered mm-hmm. In the presence of a mental health provider, right? Mm-hmm. And, um, so now if that's the case, um, and there's lots of reasons why that's arguably mm-hmm. The safest way to do it, right?
So, but if that's the case, that means that we're talking not only about for a drug manufacturer, How their drug is gonna be paid for. We're also talking about how is the mental health provider going to be reimbursed for their service. Mm-hmm. Which is not, they were already reimbursed. Right. For therapy for sure.
Right. Um, but. Are they gonna be, how are they gonna be reimbursed for administering [00:48:00] this product? And is a clinical psychologist and a psychiatrist gonna be reimbursed the same amount? Um, what about the visits? Um, what if the follow up visit is a telemedicine visit? Um, there's. All of these issues are complicated in their own right.
Mm-hmm. Now, a piece of which is how do you get a drug reimbursed? Right? But, but when you combine all of these. We now have to add another federal agency to our discussion, which is c m s, because this is gonna be a Medicare challenge, right? And, um, maybe a Medicaid challenge depending on who the patient population is.
But certainly a Medicare challenge. So c m s is gonna also play a role in [00:49:00] the uptake and, uh, use of these products. And what that means for the people who are developing products is you are in the same boat as everyone else who develops any other kind of drug. You have to be thinking about your strategy with the F D A, and you have to be thinking about your strategy with C M S or private insurers or both.
Mm-hmm. Because they will both determine. Commercial success of your product. So, um, you know, do you have to do that at day one? Eh, you know, it's worth thinking about. Yeah. Certainly as you start putting your clinical program together and doing your clinical trials. Because the other piece of this is that in addition to the doctor [00:50:00] reimbursement for the drug reimbursement, Medicare and private insurers are gonna wanna see real data about effectiveness and what they may wanna see may be different than what F D A wants to see.
And the last thing you wanna do as a drug developer is have to go and either redo trials or retrofit your data. Mm-hmm. You sort of wanna be collecting all the data you're gonna need at one time. So none of these are insurmountable problems, and as I said, these are challenges that every drug.
Manufacturer and developer has to deal with. I only raise it. And Ross, you were right to raise it because in the context of psychedelics, we haven't heard it discussed much yet. Yeah. But it's Right. It's out there. We can expect it to be, we can expect right around the corner. Yep. Um, well, I think it also highlights why.
Um, [00:51:00] people need professionals like yourself, Michael, and the team with this kind of expertise. Uh, I'm really fortunate to get to spend a lot of time with you and a lot of the things that we work on and, um, get to hear some of these conversations. But, uh, maybe just share with folks where they can find you.
Um, How to get in touch? Oh, sure. Um, well, I, uh, I work in Washington, DC um, I mentioned I'm with Holiday Knight. It's, uh, international law firm, and, um, I can be reached at, um, 2 0 2 4 1 9 2 5 1 5, or you can always reach me by email at Michael dot Werner. It's w e r n e r@hklaw.com. Well, thank you Michael. Uh, I'm sure there's plenty of folks that are writing down that information, and I would also share, uh, I'd also like to share as well that folks, um, if folks are interested, they can contact, [00:52:00] uh, you or myself, uh, as we're hosting an invitation only event since September 13th in your offices in DC for the launch of the Modern Health Alliance.
And maybe just tell folks a little bit about what this is. It's a really exciting project. Sure. So the Modern Health Alliance is a multi-stakeholder group. So we, um, we're just launching as Ross as you mentioned. We are, um, comprised of, um, Venture funds like, uh, bond Venture. We are also, uh, have entrepreneurs and companies that are developing products in the space.
We anticipate having researchers, uh, academic researchers as well as, um, veterans or consumers and patients. So it's really meant to bring together the community of people. Who are [00:53:00] looking to advocate for policies that will promote the rapid development, uh, and, uh, testing and market approval of, uh, psychedelic products and cannabis products.
So, uh, we absolutely hope you'll join us. It's really exciting. Um, you can find us@modernhealthalliance.org. And you know, it was really interesting, Michael, this was, you know, probably a year and a half ago we started talking about this. Yeah. From our perspective, these conversations around reimbursement and the landscape between d e A and f d A and.
You know, the traditional drug development space, you know, um, we weren't seeing any sort of, uh, coalitions out there that were really focused on access and informing the incumbent healthcare system such that, you know, ultimately patients can get access to these. These things. So really excited to be a part of it.
Uh, and as I said, if anybody would like to find out more, they can reach out to [00:54:00] us directly or Michael who kindly shares contact information. So Michael, um, that's a lot we've covered. I've got copious notes and we'll be coming back with, um, uh, a request to do, uh, part two of this as I'm sure a lot of folks will, will be interested in.
But, uh, thank you so much for your time today. I really appreciate it. Yeah, my pleasure, Ross. Always great to talk. Great conversation.