Wellness and longevity services are growing rapidly, with peptides creating new regulatory challenges for clinics. In this episode, Sam Pondrom, ByrdAdatto’s newest partner, explains what practices need to know before offering peptides. Tune in to understand what peptides are, why they are increasingly popular, and how the FDA and state laws regulate their use. Get insights on compliance, sourcing, and risk management to help protect both patients and your practice.
Listen to the full episode using the player below, or by visiting one of the links below. Contact ByrdAdatto if you have any questions or would like to learn more.
Transcript
*The below transcript has been edited for readability.
Intro: [00:01] Welcome to Legal 123s with ByrdAdatto, legal issues simplified through real client stories and real-world experiences, creating simplicity in three, two, one.
Brad: [00:13] Well, welcome back to another episode of Legal 123s with ByrdAdatto. I’m your host, Brad Adatto, with my co-host, Michael Byrd.
Michael: [00:20] As business attorneys for health care practices, we meet a lot of interesting people and learn their amazing stories. This season’s theme is the business of medicine today. Gone are the days of Grandpa’s medical practice, Brad, with paper charts-
Brad: [00:37] Ooh
Michael: [00:37] … and old-school treatments.
Brad: [00:39] That’s terrible.
Michael: [00:39] We’ll confront the business and health care issues faced by the modern medical practice.
Brad: [00:44] That’s awesome, Michael. Well, Michael, we get to start off with something really exciting here. On today’s podcast, we’re actually bringing on one of our newest partners at ByrdAdatto.
Michael: [00:54] I know. I’m excited, too. We’ll bring him on in a moment, but the partner room at ByrdAdatto now has a much higher average height.
Brad: [01:03] Mm-hmm.
Michael: [01:05] First, though, Brad, I have to ask you, have you heard the story about the modern-day Forrest Gump? And please, I’m begging you, please, Brad, do not answer in Forrest Gump voice.
Brad: [01:17] Okay. I make no promises, though, that I will not quote Forrest Gump, and no, I have not. Is this a story about someone who maybe started a shrimping empire, or played football for Alabama, or, joined the Olympic ping pong team, by chance?
Michael: [01:31] No. The article I read channels Forrest’s decision to run across the country.
Brad: [01:37] Run, Forrest, run!
Michael: [01:39] Oh man, so painful. Now Sam knows what I deal with. All right, now, this story, like all good stories, started with a bar room bet around 1996.
Brad: [01:52] You know, I was thinking about this. Bar room bets tend to be some… They make really wise decisions men often make when they make-
Michael: [01:59] Hmm.
Brad: [01:59] Wait, reverse that. Complete opposite. There’s never been a bar room bet where a good decision came from that.
Michael: [02:04] I don’t know. Wait till you hear about this story.
Brad: [02:06] Okay.
Michael: [02:06] Okay.
Brad: [02:07] Fair.
Michael: [02:07] So Carl Bushby made a bet with friends that he could walk from the southern tip of South America all the way home to England. Bushby, who is about our age, was in his 20s at the time. He was a former English paratrooper, so he did have some, some experience, so to speak.
Brad: [02:29] Well, most people can walk. That is an experience that most of us… But first, I’m a little confused here, but I mean, I know geography a little bit here, and unless Carl can walk on water, there’s a vast difference here. I don’t know how he’s going win, and second, you said he was in his 20s when he made the bet, now he’s, our age. So, I’m really interested, extremely interested, actually, to see what happened here.
Michael: [02:51] So in 1998, a little bit later with $500 to his name, Carl apparently stood at the edge of Punta Arenas, Chile, to begin a 31,000-mile expedition to his hometown of Hull, England. He thought it would take roughly 12 years. It has been 27 years, and Carl, now 56, is still walking.
Brad: [03:16] All right, I need a lot more information. So, for 27 years, he’s been walking home. Does he take breaks? Does he fly home? Does he have a wife and kids? I mean this might be taking a bet too far.
Michael: [03:29] Well, he’s not married. The article mentioned that he has had three serious relationships along the way that did not last, I think for obvious reasons, because he left to keep up with his bar room bet. I think it said he actually has taken some breaks, where he would, like, fly for a vacation to see family, but then he would return to the exact spot he left off. No shortcuts. He has walked through Patagonia, the Andes, Central America, Mexico, the length of the United States, Russia, Mongolia, and parts of Asia. He has walked some of the most remote, hostile, and politically fraught places.
Brad: [04:15] Well, I hope that he’s been documenting this adventure in a book or a blog or a podcast.
Michael: [04:22] Yeah, me too. The article I read was in The Washington Post, and it’s fascinating. There’s so much more kind of about his journey. He has slept mostly in tents on the side of the road or with gracious people that would host him along the way.
Brad: [04:36] Okay.
Michael: [04:37] And he’s apparently not cheated by advancing in any way other than walking or swimming across bodies of water.
Brad: [04:45] I’m not sure if I feel bad for Carl, that he’s spent most of his life trying to complete a bar room bet or impressed with him that he’s still going on a bar room bet.
Michael: [04:55] Well, and apparently, he is on pace to complete his journey in September of 2026.
Brad: [05:01] Okay.
Michael: [05:01] I don’t know what he’s going to do with his life after that.
Brad: [05:02] I don’t know. Start on the bar room bet.
Michael: [05:05] I know. All right, well, let’s transition to our guest, who made the perilous decision to walk almost his entire legal career path with the two of us.
Brad: [05:14] Ooh, I like how you tied that together. Well, done.
Michael: [05:16] Yes, yes. Our newest partner, Sam Pondrom, joins us today. Sam is a partner at ByrdAdatto. He went to undergrad at Oklahoma State University. Before going to law school, he worked as an accountant for two construction firms. He went to law school at SMU. Sam lectures throughout the country at medical conferences on various issues in the business of medicine. Sam enjoys cooking, playing basketball, which makes sense if you’ve met him. He loves watching Oklahoma State football and Dallas Mavericks basketball. Sam, welcome.
Sam: [05:55] Well, thanks for having me. One point of clarification: did not love Oklahoma State football this year. It was a tough one, but you know, things are on the upswing. But man, I’m really excited to be here for a variety of reasons. You know, of course, the partnership announcement, I’m still sort of in disbelief and over the moon on that one, but as you guys, you know, we’ve, we’ve worked together for a long time, y’all know that I love talking. I’ll talk to anyone, including myself, and then to, you know, sort of bury the lead a little bit is, nerding out on peptides as well, and making sure that everybody understands exactly kind of what we’ve got going on there.
Michael: [06:39] And audience, the talking to himself part, he gets that from Brad.
Brad: [06:42] Yes, I taught him well. Well, Sam, I guess we can get the first question, you know, right up front: What’s the furthest you’ve ever walked?
Sam: [06:50] You know, I’m not sure. So, I had the good fortune of being young at a time when phones and watches weren’t tracking our every movement. And so, you know, I’ve had some pretty epic constitutionals myself, but I don’t know that I’ve ever really measured them. In between junior and senior year of college, I was in, Europe and did a ton of walking there. So, I’ll answer it this way. In college, I started training for a marathon, and one morning I got up and ran 17 miles with my friend. He was on the cross-country team, so this was much easier for him, and that’s the longest I’ve ever run or walked that I’ve tracked. That was the end of my distance career.
Brad: [07:36] So the 17, you were like, that’s good enough for you for the rest of your life?
Sam: [07:41] Yeah, I got done, and I remember sitting in class just thinking, “Why did I do that? I don’t want to do that.”
Brad: [07:47] That’s fair. I understand.
Michael: [07:49] Yes, fair. All right, well, let’s jump into it. I’d love just first to take a moment for you to talk a little bit more about your background, anything we didn’t catch, and you know, obviously a lot of our audience has probably heard you on the podium before, but for those who haven’t, just introduce yourself a little more.
Sam: [08:08] Yeah, absolutely. I mean really back to basics, I mean, I’m Sam. I’ve been here for nine years now, been practicing for 10. I clerked for these guys back when I was a little baby attorney and a little bit skinnier, you know, but, um-
Michael: [08:26] As we all were.
Sam: [08:27] Yeah. I’ve really had the, the good fortune of being able to grow and develop with y’all and you know, I always, when people sort of ask me about myself, I always say I’m kind of an exercise in contradictions. Like, I love all things sports. I play them as often as possible. I watch them, I coach them. But I’m also a big kind of cerebral person. Love books, love puzzles, love video games. As y’all know and have referenced, I’m a very large person, but I’m still somehow the runt of my brothers, and I get accused of being sneaky, which is a mystery to me. I’m very logic-driven, and I love analysis, and I think it really feeds into, you know, my career choice. But I also love just good, dumb fun. I love stand-up comedy, a dumb movie, whatever, just to have some fun and turn your brain off a bit.
Brad: [09:26] Yes, and having met your brother for the first time, it was funny to see, you’re always like, “You’re the shortest one in the family.” Like, “Uh, your brother’s tall, too.”
Sam: [09:34] Yeah, and the one you met is the tallest one and so I think it’s, the difference is more stark there. The middle brother kind of splits, or the oldest brother splits the difference.
Brad: [09:43] Well, cool Sam, kind of jumping into today’s podcast, you know, as Michael said in the beginning of this, this season, our theme is The Business of Medicine Today. And as you kind of said, one of the hot topics that in the business of medicine that these days are centered around wellness and longevity services, that seems to be accelerating. We hear questions on this from, you know, lots of different clinics. Talk in general about, uh, what you are seeing in terms of elective practices offering these types of services first.
Sam: [10:13] Yeah, absolutely. I think this area is particularly interesting because it’s an area of medicine that’s neither, like, acute or reactive. It’s patients trying to get ahead of the curve and be proactive about their health, and it leads to interesting factual scenarios and interesting new areas of analysis. And so we see a lot of things like peptides, where the goal of it isn’t necessarily to treat an existing condition, it’s to move the body to a healthier place. And because of the way our health care system is designed, a lot of it is backwards-looking, and we’re looking at: What does this do? What does it treat? And when we get into these forward-looking items, we have to really understand the regulatory environment, both federal and state, to ensure that, you know, we’re doing things safely, and we’re doing things within the standard of care. So a lot of these types of uh… We’ll call them drugs. They are drugs. I think that’s an important thing for everybody to understand. The problem is, they’re not necessarily approved drugs, and same thing with devices and, you know, taking treatments and utilizing them for other purposes. All these things we’re seeing a lot in this, you know, functional medicine, longevity, anti-aging, whatever you want to call it.
Michael: [11:46] And this is, I mean, a lot of these treatments are kind of on the fringes of medicine in the sense that, you know, they’re all kind of cutting-edge, new treatments, and that kind of increases the risk profile as you’re trying to solve all this.
Sam: [12:06] Yeah, it really does, and the interesting thing to me is… I guess two things that are really interesting to me is, a lot of these things have existed in other forms, or they exist in you know, other nationalities…and so, they may be approved, say, in, like, Europe, and they just haven’t been adopted over here. And I think it’s led to a lot of at least potential change in the way we look at devices and drugs and the treatments that come from them. But I think the other thing that’s interesting to me, too, is we have a certain amount of the tail wagging the dog, so to speak. What I mean by that is patient-driven care, where they’re coming in, and they’re talking to their health care provider and saying, “Hey, this is what I’m concerned about. It’s not actually currently an issue. I want to get ahead of it.” And so, you get a lot more ownership, you get a lot more partnership in the care experience, which I think is a really new and exciting thing.
Brad: [13:14] So let’s really zero in on the hottest of the topics it seems like we hear about: peptides. Talk to the audience about just what are peptides and kind of how are they commonly offered, or how do we see them show up in clinics?
Sam: [13:31] Absolutely. So, one thing I want to clarify before we dive in is what we’re going to talk about are be non-GLP-1 peptides. Obviously, GLP-1’s is a super-hot topic, something we’ve covered extensively, but in this particular case, they’re pretty well-trodden ground, and now things are moving beyond them to other types of peptides, and that’s really what we’re going to look at here. In terms of what we’re seeing, peptides of a wide variety, are basically things that are found in either animals or plants that have specific bodily functions. And the goal of utilizing these peptides is to take things that for the most part is likely functioned well when we were younger and ensure that they either continue to function well or return them to the state they were in you know, before we started ageing. And because of this, and because there’s not necessarily something, quote-unquote, “wrong” or, you know, an acute condition, that’s where we start to see some of these issues.
Sam: [14:42] Because we have kind of an odd situation where we have things that are potentially useful and may have been part of other drugs or may have been used for previous functions, but now are just kind of shelved, and people are trying to pull them back off the shelf for care before they’ve gone through the regulatory process.
Brad: [15:03] Yeah, and I think you said this right in the beginning, Sam, which is good. You know, we’re always looking at different elements, but in this particular case, especially with peptides, most of these clinics, you know, they’re cash-based, so they don’t even think about the federal rules. But with peptides, it’s interesting because you definitely have some federal and state considerations if you decide to even consider offering them.
Sam: [15:24] One hundred percent, and it’s an interesting distinction. When we’re talking about the federal side of things, we’re really looking at, in general, the drug or device, but in this particular case, the drug. You know, we’re looking at most likely the FDA and what is the approval level for these particular items, and that’s kind of where the analysis really stops for the federal side. And it’s something that I think people tend to lump together, but we have to separate it out. Are we talking about the drug or device itself, or are we talking about the actual application of that drug or device in the care of a patient?
Brad: [16:08] And, and just sitting on the federal one for a little bit longer, and just explain why you said the FDA would be involved, if at all? What are the risks if it’s just at the FDA?
Sam: [16:21] Right, so, as I think most of our, audience knows, the FDA, basically, it’s about safety and efficacy, right? They want to make sure that when something like a drug or device touches a patient, that there are certain baselines that are met. And what we’re looking at with these, drugs, with the peptide drugs, is that they haven’t necessarily been vetted at all, or they haven’t been vetted for the particular uses. And either way, that comes with sets of question marks regarding safety, regarding efficacy, regarding, you know, potential interactions with other drugs, and that’s where the federal concern comes from, and the approval of these drugs become a very important aspect of the overall care.
Brad: [17:12] But the pushback you’ll get immediately, though, is, you said it already, “This Same drug that I would like to use is already being used in Europe. Why can’t the federal government just let me exempt that piece?”
Sam: [17:27] Yeah, and ultimately, it’s a question of, kind of our systems versus their systems, right? And for us, if you’re within the United States, and if you are, you know, licensed here to practice, or you own, you know, a clinic here, we’re beholden to US law, and so we have to look at the, the FDA requirements for the drugs that we are ultimately, I say we, that providers are ultimately providing to patients.
Brad: [17:59] And sorry, one more thing between… you’ll hear people say, “Let’s just use it, and it’s, you know, I’m trying to prescribe something that’s off-label, versus on-label.” Does that happen with peptides? I’m sorry, audience members, I’m sticking to the federal piece of this, trying to make sure we really dive deep into that piece.
Sam: [18:20] No, and that’s a great point, it’s really funny when you explain this to people sometimes. When we talk about off-label use, there is literally a label we’re talking about here, and an actual physical label. You can go pull them off the internet. And so basically, when a drug is approved by the FDA, they produce a label that talks through what the drug is, you know, what concentrations that it’s available in, what are indications for use, what are contraindications. I mean, really, it’s a comprehensive discussion of the drug and its use. And so when we talk about something being on-label, it’s mapped out on the label for the drug by the FDA. It is the strictest level of approval. When we talk about off-label, we’re saying, “Hey, this drug that’s already been approved and we know is safe, has this secondary function that we’ve discovered.” Uh, a really good example of this are GLP-1s. They were anti-diabetic medications, and before their approval for weight loss, the weight loss became an off-label function for those drugs because of, you know, the safety and efficacy.
Sam: [19:37] So what the off-label does is we’re saying, “Hey, look, we’ve noticed this. We’ve taken time to explore this further. There is scientifically valid data of safety and efficacy, and so we are able to take this drug that otherwise would be prescribed for different functions and also prescribe it for this secondary, tertiary function.”
Michael: [20:01] And then, yeah, just kind of continuing to break down the federal level, we’ll move to state momentarily. I get questions about the peptide bulk compounding list. Talk to us about what that is, and how does that play in?
Sam: [20:20] Yeah, the bulk compounding list, it’s interesting. So the bulk compounding list is essentially a list the FDA publishes. There’s three categories to it and basically, one in three are, and I’m going to say this very generally, this is not legal advice, are okay. Category two is the one where there has been some level of evidence that there’s a potential harm for those particular drugs. And in this case, what they’re looking at is, can you use this as a component of a different drug or the main component of a drug, you know, driven by these items? And so unfortunately, there is a pretty decent crossover between the peptides that appear on category two, with this some level of apparent risk of harm, versus, you know, what people are seeking and are being, you know, issued in various manners for treatment. I want be very clear in that the biggest issue with a lot of these isn’t that there is a demonstrated actual harm to them, it’s that just nobody’s studied them.
Sam: [21:33] There isn’t sufficient data. You can actually nominate these drugs for, you know, risk of harm, and we’ve had some that have been pulled off just simply through their nomination being withdrawn, and it’s created kind of a weird set of in limbo peptides that are sitting off, not categorized at all.
Michael: [21:55] And so I’m going to connect us to the state level, and Brad and I have talked about this on prior episodes, and that’s just the fact that the FDA does not regulate the practice of medicine, so the actual decision-
Brad: [22:08] Wait, is this new?
Michael: [22:09] No, Brad, you’ve actually said this a bunch.
Brad: [22:11] Oh, okay, good.
Michael: [22:11] Okay, yeah. So as we’ve talked about before, I mean, you get into a clinic, and you have this standard of care decision-making to actually do something, and that’s not the FDA’s purview on the actual treatment side. So let’s shift and talk about what are the state law considerations for offering peptides.
Sam: [22:34] Yeah, that’s an excellent point, and the FDA is actually super clear on that, and they’re like, “Hey, we don’t tell you how to practice medicine. We’re approving the, you know, the kind of components through which you treat somebody.” And so when we get to the actual execution side, we have to look at state law, you know, first and foremost, practice of medicine definitions. But if we sort of chase that line when we’re talking about these peptides and their various states of approval, we’re ultimately looking at a lot of times experimental use for unapproved ones. You’ll hear people bring up right to try. It’s not super applicable, but then we have this kind of weird third category where, through complementary and alternative medicine, a lot of states will either say, “Hey, we’re going to put the risk on you, the provider. You have to balance risk of harm with beneficial use,” or there’s other states where they’re like, “Hey, we’re going to tell you exactly what your informed consent needs to look like, and if you follow our rules, we’ll allow you to essentially, you know, execute on these treatments despite them not being approved.”
Brad: [23:52] You said right to try. We get that question a lot, and for audience members trying to figure out what does that mean, in many states, when someone has some illness that there’s a high likelihood that they could pass away from that illness, certain states have passed laws that if there is an experimental drug, they can try to utilize that drug to help cure whatever it is or help prolong their life. That means that it’s not because you’re wanting to use peptides to prolong your life, just in general. It’s there because of some serious illness. So just kind of keep that in mind, and for most states, that’s the catch.
Michael: [24:29] Yeah. Go ahead, Sam.
Sam: [24:30] Yeah, and I was going to say, I always preach to people, chronic or terminal illness.
Brad: [24:34] Yeah.
Sam: [24:34] That’s the key for that.
Michael: [24:37] So let’s talk about some practical considerations. If a practice, you know, they’ve vetted the state, and, you know, maybe it’s a state like you mentioned, where it puts it back on the doctor, or they have kind of their own, you know, specific boundaries. You know, talk about, you know, what are the steps they should take, whether it’s the patient consent or otherwise, to, you know, implement these types of drugs?
Sam: [25:05] Absolutely, and first and foremost, supply chain’s huge. Make sure you’re sourcing from a good place. Still get your items from pharmacies. I know that sounds like a no-brainer but, there are definitely some situations we’ve seen where there are groups offering, you know, to provide peptide components and sort of shifting the risk to the providers. And, if you think you might be in one of those situations let’s talk offline. But, yeah, so first and foremost, supply chain, absolutely make sure you’ve got a good source. Make sure that anything you’re asking about, purity, you know, component building, efficacy, that they’re able to talk to you about that. They’re able to produce documentation. I think that’s your first step. Your second step, really, Michael, I mean, you nailed it, is informed consent. And again, I think sometimes, we have to go back and just remind ourselves of what these things mean. Informed consent literally means you’ve given the patient enough information for them to make a decision as to whether to be treated or not. And we don’t want to bury them in information, but we do want to make sure we hit all the key pieces, and we also want to make sure that they have the opportunity to process that and to ask questions and to really understand what they’re potentially taking on.
Sam: [26:36] And so there’s definitely a balance there, but, a really good informed consent that is pretty frank in its discussions about things like lack of approval, off-label use, compounded substances, experimental use, things like that, become a very crucial part of the overall physician or practitioner-patient relationship and that treatment relationship.
Michael: [27:00] Well, I think that audience, you’ve now officially heard Sam’s first official, presentation podcast as a partner at ByrdAdatto. We’re grateful that you were able to join us for this. It flew by. We appreciate you joining us for the Legal 123s with ByrdAdatto. What we’ll do next is go to break, and then Brad and I will come back with a quick little legal wrap-up. Thank you.
Sam: [27:30] Thank you.
Access+: [27:30] Many business owners use legal counsel as a last resort, rather than as a proactive tool that can further their success. Why? For most, it’s the fear of unknown legal costs. ByrdAdatto’s Access+ program makes it possible for you to get the ongoing legal assistance you need, for one predictable monthly fee. That gives you unlimited phone and email access to the legal team, so you can receive feedback on legal concerns as they arise. Access+, a smarter, simpler way to access legal services. Find out more. Visit byrdadatto.com today.
Brad: [28:05] Well, welcome back to Legal 123s with ByrdAdatto. I’m your host, Brad Adatto. I’m still here with my co-host, Michael Byrd. And Michael, for those who didn’t hear, this season, the theme is The Practice of Medicine Today. We’re having a great conversation with Sam. In fact, we liked it so much, we asked him to stay after the commercial. And Sam, you know, with your partner-level hat now on, can you kind of give us, everyone, a good takeaway for the end of this episode, on peptides and what to consider here?
Sam: [28:34] The main takeaway, talk to your health care counsel. I would prefer it’s us but anybody, that knows what they’re talking about, and you trust. When we’re looking at the provision of peptides and really the provision of anything that may have various levels, we’ll call it, of approval, we want to look at all of the things we talked about, right? We want to look at, okay, federal side, what does approval look like? Can we benchmark this to anything else? On the state side, what does it look like for you as the practitioner to be able to provide these to your patients? What kind of documentation, what kind of notice do we need? And then, of course, as with everything, just make sure that it’s a reputable source. I can definitely go on Amazon right now and order some unapproved devices. That does not mean I should use them on myself or anyone else.
Brad: [29:28] Good takeaway. Well, audience members, believe it or not, that is all the time we have today, but don’t worry, we’ll be back next Wednesday. When we continue to understand the practice of medicine today when we bring on series regular and partner, Jay Reyero, to discuss: Can I charge for no-shows?
Brad: [29:46] Thanks again for joining us today, and remember, if you liked this episode, please subscribe. Make sure to give us a five-star rating and share with your friends.
Michael: [29:54] You can also sign up for the ByrdAdatto newsletter by going to our website at byrdadatto.com.
Outro: [30:00] ByrdAdatto is providing this podcast as a public service. This podcast is for educational purposes only. This podcast does not constitute legal advice, nor does it establish an attorney-client relationship. Reference to any specific product or entity does not constitute an endorsement or recommendation by ByrdAdatto. The views expressed by guests are their own, and their appearance on the program does not imply an endorsement of them or any entity they represent. Please consult with an attorney on your legal issues.
