Fake or Real: It Is Legal to Compound Semaglutide, with Jonathan Kaplan, MD

August 16, 2023

In this episode, we are joined by Dr. Jonathan Kaplan, MD, a board-certified plastic surgeon and CEO of BuildMyHealth. Tune in as we unravel compounding Semaglutide – the ingredient in popular weight loss drugs Ozempic and Wegovy. Dr. Kaplan breaks down how Semaglutide works and why it is effective for weight loss. Join us for insights into Semaglutide and the opportunity compounding pharmacies have when a drug is added to the FDA shortage list.

Want to learn more? Check out these article by Dr. Kaplan: 1) New Weight Management Program Q&A; 2) Ozempic and Wegovy for Weight Loss Q&A.

Listen to the full episode using the player below, or by visiting one of the links below. If you have any questions or would like to learn more, email us at info@byrdadatto.com.

Transcript

Intro: [00:00:00] Welcome to Legal 123s with ByrdAdatto. Legal issues simplified through real client stories and real world experiences, creating simplicity in 3, 2, 1.

Brad: Welcome back to another episode of Legal 123s with ByrdAdatto. I’m your host Brad Adatto, with my co-host Michael Byrd.

Michael: Thanks, Brad. As a business and health care law firm, we meet a lot of interesting people and learn their amazing stories. Our clients commonly come to us with the latest word on the street that they heard from a friend. This season we’ll talk about stories with these legal urban legends and seek to either prove or disprove them. This season’s theme is Fake or Real.

Brad: Yes. And Michael, we have a second time guest joining us today with Louisiana Roots. And I’m excited because he might be able to decipher my New Orleans Brad language.

Michael: Brad is its own language.

Brad: Oh, that’s true.

Michael: And Brad, [00:01:00] the language of Brad definitely has its Cajun influences, but your language Brad, is mostly influenced by your mouth trying to keep up with the brain that’s going a thousand miles an hour. It took me years to cultivate following your brain. but before we get to our guest, Brad, I have some news that I think will make you more excited than anything you’ve heard today.

Brad: I feel like this is a trap.

Michael: Well, I know why LeBron James is more physically fit and athletic than you.

Brad: This is shocking news to me. I think I’m more physically fit, but I guess I’ll learn why LeBron’s more fit.

Michael: Well, Brad, he spends $1.5 million a year according to an article I read on his body.

Brad: Okay. Why is that supposed to excite me?

Michael: Well, all you need to do is start spending a million and a half a year on your body and you’ll be just like him.

Brad: Okay, Riley, [00:02:00] can you make sure that Michael puts in like, my new compensation package that I get that like LeBron workout package? Wait, wait. Hold on, Riley, hold on. Hold that thought. Let me get some clarity from Michael first. Michael, what does he spend his money on?

Michael: Actually, it didn’t say, but there’s more because this was just the setup to this article.

Brad: Oh, goodness.

Michael: It also noted that Novak Novakovic as some would argue, the best tennis player of all time, has his own investment in his wellness, and he will sometimes spend time in a pressurized egg to enrich his blood oxygen. And sometimes he speaks to his water with the hope of purifying the water with his positive thinking.

Brad: I don’t even know how to respond to that one, Michael.

Michael: It won’t surprise you. The article also talks about Tom Brady and his long published efforts to defy father time with his various supplements, powders, and stretching routines.

Brad: Was any of those supplements or stretching is stretching [00:03:00] for the supplement called Tito’s?

Michael: No, that’s like New Orleans style, Louisiana style of age defying age. Okay. Okay. It gives you heart, courage and all sorts of superpowers.

Brad: It’s not about these athletes. What was this article about?

Michael: It was about a person named Brian Johnson who makes LeBron the Joker Brady, even you with your Titos look like amateurs when it comes to fighting age.

Brad: Okay. Never heard of this guy.

Michael: Well, I had not either. So here’s the name of the article, “How to be 18 years old again for only $2 million a year”.

Brad: Well, I could save him a lot of money because I’m basically a 13 year old

Michael: And you don’t pay anything, do you?

Brad: No.

Michael: Well, touché. But Brian Johnson’s not, he does not been gifted with the immaturity or maturity, I’m sorry, maturity of a 13 year old. So Brian Johnson is a 45 [00:04:00] year old tech mogul in California, and he apparently has more than 30 doctors and health experts monitoring his every bodily function. The team’s goal is to help reverse the aging process in every one of his organs.

Brad: Yeah. This reminds me like, maybe his name should be Steve Austin, aka the bionic man – the seventies show, or I think it’s called the $6 million Man, right?

Michael: I’m acutely aware, number one, that we have a doctor waiting to join us and I’m talking about someone who’s trying to reverse age, and then you bring the bionic man in. You know, we’re losing credibility by the second. Well,

Brad: You’re assuming we had credibility.

Michael: That’s true. Fair enough. So Brian apparently goes through dozens of medical procedures on a monthly basis. He has a strict vegan diet, he exercises an hour a day and sleeps the same hours every night. Okay. He even wears glasses that block blue light for two hours before he goes to sleep.

Brad: This sounds terrible, but I guess the question is, is it working? [00:05:00]

Michael: I guess. I mean, I saw a picture of him and he

Brad: Looked better than me.

Michael: He definitely looked better than you. He looked ripped for a 45 year old. His skin was a little translucent. But yeah, I mean, he was ripped and the doctor’s report in the article that his body is starting to get medically younger. He has, according to the article, 5% body fat, he has a heart of a 37 year old, the skin of a 28 year old, and the lung capacity of an 18 year old.

Brad: They didn’t talk about his maturity level though, right?

Michael: Yes. No, he still hadn’t caught up to you.

Brad: Okay. Well, besides trying to make me feel better that I can be like LeBron and only spend 1.5 million on my health, where are we headed with this today, Michael?

Michael: Today we have to dispel another fake or real myth, and we’re going to bring a doctor in to join us to help. So our topic covers a treatment that has the entire [00:06:00] country in a frenzy right now. And it’s kind of trying to reverse the aging process in a different way. This is medicine that helps with weight loss. Brad, have you ever heard of Ozempic or Wegovy.

Brad: Yes. Actually, in December of 2022, I was at a plastic surgery conference and at the dinner I was sitting with a bunch of plastic surgeons and they kept talking about this weight loss drug that many of them either themselves were using or their patients. Some of them had been using it for six, some of them have been 12 months. And they all kept talking about these amazing results. And that was the first time I had heard of it. And some of those other plastic surgeons, it was the first time they had heard it and how their patients were just flocking in because of what results they’re receiving.

Michael: Yeah, absolutely. And these are prescription level medicines and there’s a shortage throughout the country. And so, today we’re going to talk about whether compounding a generic version of these FDA drugs is a viable [00:07:00] option. The term many around the country have heard is Semaglutide.

Brad: Sure. Well, let’s bring on today’s mystery Cajun guess and learn more about them.

Michael: So we have Dr. Jonathan Kaplan joining us. He’s a board certified plastic surgeon, originally from Alexandria, Louisiana. He’s a UT grad – hook him, LSU Med School, completed his plastic surgery fellowship at the Cleveland Clinic. He is the owner of Pacific Heights Plastic Surgery in San Francisco. Areas of focus range from facial to body cosmetic surgery, as well as non-surgical procedures. He is the CEO and creator of the company now known as Build My Health. He is a speaker and writer. In fact, we’ve been on panels with him a couple of times, and he’s joined us, as we’ve said on our podcast. Jonathan, welcome.

Jonathan: So happy to be here. Thanks for having me again.

Brad: Yeah, absolutely. And I don’t know, should we call him Jonathan or Dr. Bay? I always forget. Are we allowed to call you Jonathan? [00:08:00]

Jonathan: You can call me whenever you’d like.

Brad: Awesome. Well, I guess the first question’s really important here is do you have a team of doctors working with you around the clock to reverse your aging process?

Jonathan: No. And as you were describing all these procedures he gets each month, it’s like how much time does he have to like live his life? It kind of sounds like a miserable experience.

Michael: No doubt.

Brad: Exactly.

Michael: I think – and I remember seeing something about a very frequent number of colonoscopies, this can’t be worth it. Well, onto the topic today. So I’ll start with some context because we had you on before and we talked about the No Surprises Act the last time we were on. But I’d love for you just to kind of reintroduce your practice and your app, Build My Health, and kind of tell the audience what you’ve been up to and what you’re up to.

Jonathan: Yeah, I know being on for the No Surprises Act [00:09:00] and now this time being on talking about the weight management medications doesn’t sound very connected, but it really does make sense. It all started back about 10 years ago. I ,as a plastic surgeon always had patients calling in asking about pricing on cosmetic procedures. It’s a very difficult conversation to have over the phone because you could be on there forever explaining the cost of these different services. And then after you tell them the number, they hang up and you’ve gotten nothing out of it; you don’t know their name or anything. So I developed a platform called Build My Health and it allows doctors, providers, not just aesthetics, but providers to put a price estimator into their existing website so consumers can come on, check pricing for any service they want, but only after they put in their contact information. So it generates a lead for the doctor and also gives the patient a much more realistic understanding about the cost before coming in for a consultation so that the consultation doesn’t end in sticker shock. So it was all about price transparency and then that’s what the No Surprises Act was all about is providing that level of price [00:10:00] transparency, but on a federal level now.

And then what also we allow through that price estimators that consumers can purchase nonsurgical services like lab tests or x-rays or Botox or fillers. And in addition to purchasing things through the price estimator, they can also sign up for memberships and subscriptions, things that require monthly charges. And so, what has really kind of blown up what the Build My Health platform and also in my own practice, is that patients are signing up for these weight loss medications as a subscription. And so they get charged every month whether they’re signing up for the semaglutide or the practice. And we’ve been able to scale our weight management program to over 350 patients now. And the only way we can scale that is because we’ve automated the process with the Build My Health platform or they’re charged every month. And if their credit card fails, our system helps with all the automated Dunning. For those of you who don’t know what Dunning is, it’s like a 17th century term [00:11:00] when a credit card fails although they must not have been using that term for credit cards back in the 17th century. But it’s the whole idea of that, you know, sending them an email saying your credit card failed, click here to update your credit card so your front office staff isn’t having to do it manually.

So, that’s how it all wraps up together with price transparency, online purchasing subscriptions. And so we’ve gotten into this – it’s kind of evolved now that Build My Health is not only providing people with, you know, a platform to sign up patients for these automated charges for medication, but because people are having trouble finding the compounded versions of the medication, which we’ll talk about some more; we’ve actually evolved into now we’re providing consulting services for people to start these turnkey weight management programs. So, that’s where we find ourselves today. Is it still providing price transparency, still offering price estimators and things for doctors’ practices to generate leads, but also the ability to help implement a turnkey weight manager program and support them in that process and help them source their medications [00:12:00] for compounded meds.

Michael: So your clients are other doctor’s practices or the Build My health. clients are?

Jonathan: Exactly right. At this point, I was talking to somebody about this yesterday and they’re like, well, why don’t you just go straight to the patient, kind of like a row or one of these other online services. And there’s lots of reasons, but I guess the easiest reason to explain is that as a provider, I want to help other providers who then can go out and provide these services to their patients. And also, because you need the provider to write the prescriptions for the medication or order it from the compounding pharmacy. So yes, our clients right now are for Bill My Health or other providers.

Brad: Yeah, that’s awesome. And the fact that, and I know that you’ve talked about this before, it is not just you, you’re helping everyone else be compliant by using that, those processes that you’re putting in place, which is very smart.

Jonathan: Exactly. Because I mean, you’ll hear about people going to other states and picking up these compounded medications because they don’t have a license in California. Well, that’s not legal. And so, [00:13:00] we can help you figure out a way to do this legally. Because what I always say to other providers and even in my patients is that I’m still a plastic surgeon, I’m still operating, still have this license, and I’m not going to go down for doing something sketchy on the weight management side for an ancillary service that we provide and put my license in jeopardy so that I can’t continue being a plastic surgeon, so I’m going to do things the right way is my point.

Brad: That’s awesome. So let’s talk about, you know, we’re talking about what the platform is, but let’s really dive into Semaglutide. Tell us about the efficiency of using Semaglutide for weight loss.

Jonathan: So, Semaglutide is the active ingredient in Ozempic and Wegovy, and just for some background, Ozempic was approved for type two diabetes in 2017. They realized, Novak Novakovic, the manufacturer of the pig pharma realized the patients were losing weight. So they rebranded it and got it reapproved by the FDA in 2021 under the name Govy, but they’re still the same active ingredients semaglutide. And because those drugs are on [00:14:00] an FDA shortage list, compounding pharmacies are allowed to make a duplicate of a commercially available drug without patent infringement issues. And so. What we’re getting from the compounding pharmacies, we’re able to track all these patients. We’ve had patients on semaglutide now for seven months. We just got access to Tirzepatide from a compounding pharmacy, which is the active ingredient Mounjaro, which the Wall Street Journal calls the King Kong of weight management drugs.

And so we’re able to track all this internally, which is really exciting to not have to take the word of these different studies that were financed by the company that makes the drug, and so we’re able to see the effectiveness. In fact, to your question that Semaglutide on average, our patients are losing seven and a half pounds in the first month, 12 to 13 pounds over the first two months, 19 pounds over the first three months, 24 pounds over the first four months and 32 pounds over the first five months and beyond. And there are side effects associated with these medications that are well-known, but they are extraordinarily effective. And I think that’s the [00:15:00] reason that there’s so much buzz about it everywhere is because it’s kind of like .Botox has a lot of buzz ’cause it actually works. Viagra had a lot of buzz because it actually works. And now these medications really are incredible that they’re not amphetamines, they’re not phentermine or finfin that can cause valvular dysfunction of your heart. These are incredibly effective weight loss meds that actually have a relatively safe – relatively good safety profile. Yeah.

Brad: And can we, for those who aren’t familiar with the drug, I mean, does it make your metabolism go up or does it suppress it? Like, what is the reasoning behind it?

Jonathan: No, thanks for clarifying. So I always describe it in that these medications, this whole class of drugs, whether you’re talking ozempic, wegovy, [umclear15:46], Semaglutide, this whole class of drugs has been around for over 20 years and they’re part of this class of drugs called incretin mimetics. And all that really means that a fancy way of saying that they mimic naturally occurring gastrointestinal hormones that are released in your [00:16:00] body after you eat. And those naturally occurring hormones, GIP, like peptide or gastric inhibitory peptide that these drugs mimic, they are effective in helping you lose weight through three mechanisms. One is they think that they affect your hypothalamus in your brain to suppress your appetite. Another way they help you lose weight is through delayed gastric emptying. Meaning food moves more slowly from your stomach to your intestines. You feel more full, you eat less, you lose weight. And then the third way is they all, because this – and this goes back to what they originally designed for was type two diabetes. They enhance secretion of insulin from the pancreas, and that release of insulin also makes you feel full. And so, that’s another way they help you lose weight. So, it’s those three ways that they really help you lose weight.

Michael: Is there a kind of an ideal candidate for these medications?

Jonathan: They are technically approved. Keep in mind that Ozempic is approved for type two diabetes, but it can be used off-label for weight loss. [00:17:00] Wegovy is technically the only one of these, it’s FDA approved for weight loss. And according to the FDA and big pharma, the indications for people who are appropriate to be on it are those who have ABMI of greater than 27 or with some obesity related conditions like sleep apnea, high blood pressure, diabetes, or somebody with ABMI greater than 30. That’s technically the indications to be considered on-label. But there’s plenty of people using it that maybe have a lower BMI than that, that have PCOS that have other reasons to be on it, and you can still legally treat them. It’s considered off-label, but totally legal and okay.

Brad: Yeah. And first off, Michael, before you go to the next question, I’m so happy he’s explaining this. Those big words he just said made us seem a lot smarter as a podcast.

Michael: Well, anytime you’re not talking, Brad, you sound smarter.

Brad: Thank you. That makes me feel so good. I’ll just look here pretty for you.

Michael: Yes. Riley move the camera off Brad a little bit. Well, so that [00:18:00] actually brings us to kind of the ultimate question that we want to address today, which is part of our theme this year and that’s the whole faker real. Is it legal to compound Semaglutide?

Jonathan: I think that this whole class of drugs, this weight management program, I found this so fascinating because it touches on so many things. It’s like interesting from a pharmacological standpoint and it’s super interesting from a legal standpoint of all the things I’ve learned in this process. So yes, it is legal to get Semaglutide from a compounding pharmacy. It’s legal for the compounding pharmacy to make it. There’s several links that I have on my website where you can go and read the official FDA documentation, clarifying, clarifying that clarify if there is a drug on an official FDA shortage list, the FDA short, it’s not just a post-it note, it’s like an official FDA shortage list that you can Google. And you see all the drugs that are on shortage currently.

I mean, acetaminophen sometimes is on shortage and then a lot of kids are in the [00:19:00] hospital sick, and so compounding pharmacies can make duplicates of that. But anyway, in this particular case, Mounjaro, excuse me, tirzepatide, the active ingredient, Mounjaro, Wegovy and Ozempic, they’re all on an FDA shortage list, and they have been for a long time. And so, the law is that if there’s drugs are unavailable, then compounding pharmacies are allowed to fill the void and make duplicates of these drugs. And so the idea though is if it ever goes off the f d a shortage list and the compounding pharmacies aren’t allowed to make them anymore. So what compounding pharmacies are doing is that, you don’t just get the Semaglutide when you order from them. They mix the Semaglutide with B12 or some other supplement that doesn’t really change the nature of it. But because they’re saying that that makes it materially different. Like for example, you can’t get Semaglutide with B12 from a drug manufacturer. Only we can make it. And because only we can make it, that makes it unique and materially different. So even if these drugs go off the FDA shortage list, compounding pharmacies are claiming [00:20:00] that they’ll be able to continue making these mixed with B12. I don’t know how the FDA feels about that, but that is kind of the thinking, how the thinking goes.

Brad: Amazing. And I think in the second half in the legal, we’ll dive a little bit deeper on that topic. But first off, thank you for answering the question.

Jonathan: I also want to clarify something as far as if it does go off the FDA a shortage list, obviously the FDA could change the rules and prove me wrong. But if the rule is really that if there’s ever not a shortage, they’ll go off the FDA shortage list. I don’t believe there’s ever going to be that there’s not going to be a shortage. I think there will always be a shortage. And I have this graphic that I designed that really shows why that if you think of all the potential 42% of Americans that are considered obese, that if all of those potential people went on these medications, remember that they have to take – these are once per week injections. And let’s say they take it for a year. And if you take all the potential candidates for obesity in America, and they all take these [00:21:00] medications once per week for a year, that equals 6.7 billion shots a year. Compare that to Covid and you get one shot a year and there’s 330 million Americans. So that’s 330 million covid vaccines, and they had trouble keeping up with that. And obviously there was covid vaccine hesitancy. There’s no hesitancy with these meds. People who were worried about the covid shot, they’re excited about taking the weight loss shot. And so, I just don’t see how they can ever keep up with that demand that approaches 6.7 billion shots a year. I just want to mention that.

Brad: That’s amazing. I know I definitely want to dive a little bit deeper into that, but I want to have a follow up on the compounding though. And for those of our audience members may have heard the news about compounding pharmacies getting in trouble and it had a lot to do with the salt based form that they were using for the Semaglutide. Are you familiar with this particular issue?

Jonathan: Yeah, and I really believe that a lot of the things that you hear about that doctors or compounding pharmacies are doing that I think it’s all [00:22:00] planted affirmation by Novak Novakovic, the manufacturer of Ozempic and Wegovy, because they can’t keep up with the demand, they realize they’re losing market share at compounding pharmacies. So I think a lot of this information you’re getting, I’ll say it’s necessarily misinformation. I’m just saying it’s planted by them. And what they’re talking about is that there’s a Semaglutide base and a Semaglutide salt. And Semaglutide salt has a sodium ion on it, that theoretically I think if you place the Semaglutide salt in saline, or in any kind of diluent, that the sodium is released and it becomes a Semaglutide based, so it ends up being essentially the same thing. So based on the compounding pharmacist I’ve spoken to, it doesn’t really make that big a difference.

However, the thing that’s critically important to understand is that Semaglutide salt is typically used for research purposes and that’s why you’re able to go online and buy it without a prescription, Semaglutide salt. But the efficacious and the safety of that has not been proven the way the Semaglutide base has. So when you see these things about the FDA’s sending out alerts about Semaglutide salt, it’s [00:23:00] not really that I’m providing you with the Semaglutide salt or all these compounding pharmacists providing Semaglutide salt. They’re just saying that if you’re going online to get Semaglutide without a prescription, that means you’re getting the research grade Semaglutide salt. You’re not getting the Semaglutide base, which is potentially not safe. So I think Novak Novakovic is just stirring up the pot to make it look like all compounding pharmacies are providing this, and doctors like me are providing the Semaglutide salt rather than the base. But what people don’t understand is that manufacturers that provide the medication to compounding pharmacies who then sterilize it and then provide it to doctors like me in states where they have a license with the Board of Pharmacy, that those are the Semaglutide base and we have a certificate of analysis that can prove that it’s a Semaglutide base. I think they’re kind of making it look like that. Oh, all of the ones that are provided other than what we’re providing at Novak Novakovic must be illegal. And that’s just not the case. I mean, there’s a way [00:24:00] to prove that your entire supply chain is totally legit, comes from an FDA approved facility and is provided by a compounding pharmacy that has a license in that from the Board of Pharmacy in your state.

Michael: It’s fascinating. Yeah. Well, I can’t believe it. Our time has already passed. It’s been fascinating as Brad alluded to, to hear someone that actually knows the science behind all this is really interesting. What we’ll do next is we’ll say goodbye to Jonathan, we’re so grateful that you came on. We’ll go into a commercial and then on the other side we’ll talk about some legal insights from our discussion today. Great.

Jonathan: Thanks so much for having me.

Michael: Absolutely.

Brad: Yeah, thank you.

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Brad: Welcome back to Legal 123s with ByrdAdatto. I’m your host Brad Adatto, with my co-host Michael Byrd. And we just had our guest, Dr. Jonathan Kaplan on, the Cajun. Michael, this season’s theme, in case you did not know is Fake or Real. And we had Dr. Kaplan come in come on in here and really help us talk about compounding and more importantly, the weight loss drug that everyone keeps talking about, Semaglutide.

Michael: Yeah, we learned a lot. Of course. as you mentioned during the episode, we were sounding smarter because we weren’t talking and listening to him. And it was really great because there’s a lot of information and misinformation that’s out there about[00:26:00] the Semaglutide frenzy right now. What we learned, you know, getting right to it is that because the Ozempic and Wegovy and others that are FDA approved weight loss medicines are on this shortage list, that it is real, that you can compound kind of a “generic version” of the Semaglutide. And we learned so much more. Like, he really kind of broke down some of the science behind the Semaglutide.

Brad: Yeah. And I mean, that’s perfect. I mean, and he’s correct and traditionally, as you were mentioning, Semaglutide is not itself available for compounding, but as we were discussing in the beginning of this episode is because it’s normally commercially available, they couldn’t compound it. But because the demand is so high and it’s on that short list with the FDA, that has allowed these [00:27:00] different companies to compound it, which I also found fascinating is not only compounding it as written, you know, as it would be prescribed, but that they’re actually adding other additional things to make it not exactly meaning, if it ever came off the short list, they may be in a different situation.

Michael: Yeah. And so, he also talked about this salt-based issue and I got a little bit better of an understanding. We know that there’s been news about litigation, all this stuff. And so, what it all kind of centered around is that there’s the salt form of Semaglutide that Jonathan did a far better job than we could have, of explaining the, the differences. But where that does create some controversy is that, you know, it’s not the same [00:28:00] as the FDA approved version. And there’s laws that would protect, especially if you’re holding yourself out, that that drug out to be the same or to be the compounded version of that.

Brad: And I’ll just say this is that, it just led some – there’s a lot of confusion out there with weight loss centers, med spas, compounding pharmacies how they’re marketing Semaglutide products, particularly with respect to compounding pharmacies using, again, if they are using an unproven salt version of the Semaglutide. And again, I don’t know this to be true, but that’s obviously the claimant out there. And in response, several state pharmacy boards have actually issued warnings, so not just the federal government about using assault version. And obviously the FDA, which we were referencing earlier in this episode, did publish in May 31st, 2023, additional guidance on this. Which is basically, you know, further making these brand drugs that obviously[00:29:00] this drug company spent all this money on and they want to stop the confusion of other people using their drug or advertising that they’re using this particular drug because it’s not the same drug. The branding of it is a real big issue.

Michael: And for those who don’t know, Novak Novakovic is taking legal action against med spas and compounding pharmacies. There’s at least four lawsuits that have been filed in federal court, and there’s probably actually more, I think I noted, but New York, Tennessee, Texas, and Florida. And so, there are some federal and state laws that they should consider. We talk about that.

Brad: Yeah, besides this lawsuit that made the national headlines, both the federal and state government can make claims under the consumer protection laws, if you’re advertising something that’s false and misleading. Meaning, if you go out there and you say you have that brand name, but you’re actually using a compounded version of it, the practice can be subject to a whole host of rules, including your [00:30:00] state medical board rules as it relates to medical advertising. And much like the FTC, most state medical boards say if you do something that’s false, deceptive of misleading, you can get in trouble with them. The FTC kind of uses the unfair methods or competitive or unfair or deceptive. I mean, that’s their rules. But at the end of the day, false, deceptive, misleading is really what they’re looking at. So any practice utilizing these weight loss drugs, make sure that you’re compliant with these, both medical board, pharmaceutical boards, and of course the federal government rules. Michael, you know, last few seconds, what are your final takeaways?

Michael: Yeah. We’ve observed this brad several times in health care, and that is a “market inefficiency” appears, and there is a way that people can make a whole lot of money really fast and creates a frenzy. And we’ve seen it in different, whether it’s reimbursements, [00:31:00] opportunities and insurance along the way or other things here because of the shortage and the ability to use compounding and leverage the cost that’s significantly less of using a compounded version. And you marry that with this frenzy of people that want it; you’re going to attract all sorts of people into wanting to offer Semaglutide. And so, there’s going to be a lot of bad actors, and we’re already starting to see that. And besides the warnings that we’ve talked about where there’s these lawsuits and FDA issues is the reminder that this is the practice of medicine, and that if you’re a patient wanting to get this, there’s a process to get treated and prescribed from a doctor for this. Jonathan alluded to it, part of their service is providing it in a safe environment. But there’s going to be, and we’re seeing [00:32:00] it, people that are going out and they’re trying to find doctors that’ll lend their license and they’re scaling with pretty aggressive marketing schemes to get patients signed up, and there’s really no oversight in some of these. And so, there is some risk out there to everyone, on the business side from a compliance perspective, if you get in bed with the wrong people to help, support this service line or of course to patients if they’re kind of going into one of these non-compliant setups

Brad: Yeah. So that they can all look like the $6 million man afterwards?

Michael: Exactly.

Brad: Excellent. All right. Well, next Wednesday show we’ll be discussing fake or real, a physician can own a MSO. Thanks again for joining us today. And remember, if you like this episode, please subscribe, make sure to give us a five star rating and share with your friends.

Michael: You can also sign up for the ByrdAdatto newsletter by going [00:33:00] to our website at byrdadatto.com.

Outro: ByrdAdatto is providing this podcast as a public service. This podcast is for educational purposes only. This podcast is 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 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.

ByrdAdatto founding partner Michael Byrd

Michael S. Byrd

ByrdAdatto founding partner Brad Adatto

Bradford E. Adatto