transcript

Speaker 1:
[00:00] We've got some massive breaking news this afternoon. We covered it on our live stream earlier today. If you rely on compound trisepatide, compound semaglutide, you are gonna wanna watch this video. We're gonna break down the news today that a second massive 503B outsourcing facility, compound pharmacy, has halted production of GLP-1's trisepatide and semaglutide. This will have massive ripple effects to the compound world. And who better to talk to about it today other than Sabina Hemmi, who we have waiting here from GLP-Winner. She's gonna come on and talk to us about what she sees from her angle, how she sees this impacting everything in the coming days, weeks and months. Now, I just wanna give you a little backdrop. Back on, I believe it was April 2nd. On April 2nd, we brought you some breaking news that the FDA had issued a massive update in their enforcement against compound GLP-1s. Now, at the time, the industry really balked at this. In fact, I felt they were actually in their responses quite jovial about this in terms of, hey, this is just the FDA doing what the FDA does. And I saw it a little bit differently because while they were reiterating some of their some of their sort of talking points and some of their rules and regulations around compounding, they also threw in a few things there that I thought were not mentioned by accident or just casually. And that was that they were saying same drug, same dose, same injection is considered a copy and you cannot make copies of GLP-ones anymore. They said also that adding B12 doesn't make it different. They said enforcement tolerance is going to be capped at just four scripts a month. So if you make more than that, you may draw the IR of the FDA. And most importantly, they highlighted that zeppotite and semaglutite are no longer on the bulk substances list, which obviously everybody knew, but they were saying it for a reason. And so they were saying that it can't be bulk compounded by 503Bs. So here we are today. We are several weeks away from this original memo that the FDA had put out. We're now a few weeks away from that. And we've seen not one ProRx, which was another 503B compounding pharmacy. That one was shut down, I believe, around a week and a half or so after this came out from the FDA. I want to pull up that tweet as well. Let's see here. I believe this was maybe the 11th or so. April 8th. On April 8th, ProRx Pharmacy halted production in response to an FDA demand letter. And that was potentially tied to some 483 letters that they had received in terms of their inspections that they had received. Maybe some unresolved things. But it looked like the FDA was using it at a minimum, using that as leverage to get them to halt their mass production of GLP-one compounds. Fast forward to today. The rumor going around early on when we were live earlier, that was that a Reddit rumor that 503B Pharmacy BPI had shut down their compounding of semaglutide interzepatide. These are massive outsourcing facilities. These make thousands and tens and thousands of these prescriptions per week. We're talking about maximum capacity of manufacturing these, something that is definitely going to impact the compound GLP-1 market. That's why we wanted to have this conversation with Sabina from GLP Winner. Welcome back, Sabina.

Speaker 2:
[03:39] Hi. Thanks so much for having me. Obviously, everybody's freaking out at this news. It's major news. Of course, you covered a lot of the steps leading up to this. When PRORX went away, everyone's like, is this all 503Bs or is this because PRORX has been having beef with the FDA? That was the big question. For me, I'd been texting back and forth being like, BPI is still around, BPI is still around. I think I literally texted yesterday, the day before confirming, and then today, the news broke quietly within the industry that they were going to stop making GLP-1s.

Speaker 1:
[04:16] And what have you heard in it? Is there anything you can share in addition to that? I know some of the rumors early on were essentially that the FDA had threatened that they were gonna have a per vial fine levied against them by the FDA. Are you hearing that same thing too? Have you been able to confirm that?

Speaker 2:
[04:34] I've heard that rumor. I haven't been able to confirm it. I will say that what I have been able to confirm from people in the industry is that it seems like all Bs are going away from GLP-one compounding. When I spoke to people, a lot of them think that A's are going to stick around. That's the overall kind of like what people are telling me they believe. It's interesting because I heard rumors that Bs were getting asked about GLP-one prescriptions recently and I saw, and you probably cover it, I saw that there's a study being done on compounded GLP-ones and numbers through compounding. The FDA was asking for numbers. It's impossible to know what that is because 503b outsourcing facility is they have to report prescriptions to the FDA anyway. If the FDA is asking for more numbers, it's like, is that suspicious or is that part of the normal reporting that they have to do with prescriptions to the FDA?

Speaker 1:
[05:33] And this is at the A level, the 503a level.

Speaker 2:
[05:35] This is at the 503b level. They have to report prescriptions to the FDA.

Speaker 1:
[05:40] But you were hearing that potentially the FDA was asking A's that question.

Speaker 2:
[05:43] No, asking B's that recently. So it sort of seemed like something could go. And then I've heard, you know, I heard a bunch of rumors from people that BPI was going to be asked to stop, but it's a rumor through a person. You don't actually know if that's going to materialize. For example, like some of the big news is that peptides are potentially coming in veil for compounding. Those were rumors I was hearing since September, October. So just because you hear a rumor that something's coming, it's sort of like, it matters what is actually happening, what's actually being enforced. And it's sort of like, I think there's exhaustion with rumors to the point where it's like, it's not real until it's real. And it seems like it's real for BPI to stop doing GLP-1s.

Speaker 1:
[06:23] Yeah. And I want to camp out on this a little bit because I think people need to understand, if you don't understand the difference between A's and B's in terms of compound pharmacies, just know that 503B's just have the capacity to make so much more in terms of their ability to manufacture, right? That's kind of the main, for this discussion, the main thing to understand. Tell me Sabina, based upon these two big ones going down, let's say the other ones continue to survive on for the next few weeks, and we just kind of see one drop at a time. And perhaps, what I would surmise is, we haven't seen enforcement up to this point. All of a sudden, we're seeing enforcement on 503Bs. In fact, after the first shortages ended, and then the dates came and went that the judge had put in place for mass production of essential copies, they call them, in the FD&C. We saw some of the 503Bs step back in really meaningful ways for a while. And then we slowly started to see some of them come back online, some of them making copies, but most of them making some sort of concoction of B12 and terzapatite or something like that.

Speaker 2:
[07:37] Right.

Speaker 1:
[07:37] So they kind of slowly went away and then they slowly came back. So let's say they kind of slowly go away again. What is the immediate impact of losing a ProRX or a, and now a BPI?

Speaker 2:
[07:49] Yeah. So first of all, I'll say BPI went away before when the shortage ended. For months, they didn't compound. And to be honest, they are a big enough player that it was causing delays across the entire compounded ecosystem because they weren't there. So if we're losing all these, because ProRX was not a small facility, BPI is not a small facility, first of all, in the immediate, immediate short term, people can probably still get BPI medication simply because BPI doesn't ship directly to patients. They go through basically a distributor that's another pharmacy that will mail it out to patients. So distributors can continue to mail out while they have product. So you can probably still get BPI if you order it in the next few days, maybe longer, I have no idea how much they have. But once that dries out, you know, the concern is that we're going to see delays with people being able to fill the prescriptions from anywhere.

Speaker 1:
[08:52] So talk me through what this actually looks like, practically speaking, for a telehealth company. So you're one of the viewers watching today, and you are connected with the telehealth, it uses primarily, maybe they use ProRx, and now they're using BPI.

Speaker 2:
[09:06] Yeah.

Speaker 1:
[09:08] Now, what does that transition look like, logistically on the back end for the telehealth company to try to fill the prescriptions that are existing, and then handle the new patients coming in? Like, are people going to end up waiting weeks and weeks and weeks to get their refills, or do you see that? That's possible.

Speaker 2:
[09:23] Yeah. And I'll say, it doesn't even matter if you use a telehealth that uses BPI or not, because suddenly we have prescriptions that need to be filled, that were filled by BPI, they're going to be filled by whatever compounding pharmacy is available.

Speaker 1:
[09:35] Usha.

Speaker 2:
[09:36] Yeah. Maybe not that they're not operating anymore, right? But basically, even if you'd use a telehealth that doesn't use BPI, you could still see delays, because what happens, and my hot take on the industry, is that no telehealth or compounding pharmacy is perfect, because there's such influx of new patients. We see all the time compounding pharmacies are really responsive, they're getting out medication fast, and they take on a new client that's too big, and all of a sudden everybody's having issues getting the prescriptions filled. So it's totally possible that we see that. We might, it might start out like two, three week delays, and then it might grow to being longer than that. While, you know, 503As take the load, I do think there's been a lot of investment, new 503As popping up. So it's not like 503As can't fill the gap, it's that it takes time for them to ramp up production, and to plan out batches. Compounding pharmacies, because I visited four last week, they have a lot of systems in place before they can do prescriptions. And so for 503As, they actually have a batch size limitation of 250 vials. So if a 503A does a batch of 250 vials, then they have to, you know, individually send that out to go get it tested, it's quarantined before they send it out to patients, then they have to clean the machines to do another batch of 250 vials. It's just a slower process to do at the scale that you would see compared to like a BPI that is literally an FDA registered drug manufacturer. So they're just operating a different scale. There are As that are operating at larger scales, but they still have that batch limitation. It slows everything down to do everything safely with the process that you want.

Speaker 1:
[11:29] So let's play out the worst case scenario. We get out another two weeks from now, three weeks from now, and two or three more Bs go down. What does this mean? Let's say they all go down within a month. Just 503 Bs are out. What does that look like for patients?

Speaker 2:
[11:44] Yeah. I think that means we're going to see delays on compounded prescriptions getting filled, period. We're going to see delays. I think it's possible we could already see delays just from ProRx. It just hasn't hit the supply chain yet. It takes time for that because you imagine people are refilling once a month and we have new patients onboarding to GLP-1s all the time. It hasn't really hit until we've had a month or two of time from there. I think we're going to see delays. That's it. We're going to see delays. I hope that everyone can get their medication on time. I'm not personally a big fan of telling people go stock up with six months. I'm not a fan of that. I think like three months to help with supply chain issues is probably helpful.

Speaker 1:
[12:33] Yeah. So who wins here? Does at the end of the day, does Lilly Direct win or does the gray market win? Who do you think comes out? Who benefits the most?

Speaker 2:
[12:47] I mean, I think it's both, but I think if people literally can't get their prescriptions, it's more likely to be gray. Right? Because I truly believe a lot of people on compounded medication genuinely can't afford the Lilly Direct numbers.

Speaker 1:
[13:02] I think it's interesting that we see this because when you said earlier that you hear a lot of these rumors and it's just hard to substantiate and eventually you come to this point mentally where you're like, I'll believe it when I see it. Even this 503 B rumor about BPI popped up in my live stream this morning and I thought, I hear a lot of things a lot of time, so I'll believe it when I see it. But when we were able to substantiate it, I was like, okay, the industry is saying that this is the case. We hear the same thing from the gray market folks that follow that closely. In fact, I've gotten connected with a few of them over the last couple of months and they're saying the same thing. They're seeing a big crackdown on the Chinese side. They're seeing problems with FedEx, they're seeing in shipping. They're seeing problems with even folks that are involved in the shipping of this stuff on the Chinese side, maybe even being detained by the government. A lot of this, again, rumors, but you're seeing the crackdown kind of at all ends kind of happening really intensely all at one time to definitely cut down on these non branded options we'll call it. And so I'm with you. I mean, to the extent that gray market exists, I think that that's where people go when this happens, and it's just that's the tragedy of it all is that these people don't have anywhere else to turn. They're going to turn to the gray market. So obviously, this is an impact, very impactful turn of events, something that I think a lot of us have seen coming, but just hoped wouldn't hope we were just kind of hoping for status quo. Sue's got a really good question here, and that's whether we think that this action is targeted towards just one class of pharmacies or if it's the start of a bigger shutdown. I think you kind of touched on this earlier, that you thought that this was pretty isolated to 503Bs. Do you just want to expound upon that a little bit?

Speaker 2:
[14:51] Yeah, I think this is a change in enforcement for 503B outsourcing facilities. So I think this doesn't necessarily impact A's, but then again, the FDA can change their enforcement on A's too. It's totally possible that this is the big shutdown. Do I think it's a big shutdown? No. I think that A's are going to continue. But I do think this is the beginning of the end for B's, and it might not all happen in 24-hour period. It might be a trickle in of B's that are currently doing GLP-1s to stop.

Speaker 1:
[15:25] I have a little bit different take on it. I don't necessarily disagree with you, but I have maybe a little bit more color to add on that. So I generally agree. This is targeted at 503Bs. It seems like that's the big egregious one because, again, they either have to be compounding from the bulk shortage or the bulk substances list or the drug has to be in shortage for them to compound it. So it's always been this murky area where they're just lacked really any enforcement. So why not aid because the demand is there and they have the capacity to meet the demand. Legal demand, right? Custom dosing, custom formulations is what I'm talking. Now, where I differ a little bit, I think there will be enforcement coming on A's, not universally, not like all A's are going to be shut down. But if you go back to that update that the FDA put out back on the 2nd of April, it very much felt like, okay. It felt to me like the FDA going, okay. It's coming. And if you fall in these camps, you're the one we're coming for. And so when you look back at that, the just talking about adding B12, not making it different, if they throw a tersepitide B12 into a bucket of them defining that as not a custom formulation somehow, I don't know how they were, what fancily legal footwork they're doing to come to that conclusion. But if I'm reading, I'm not reading it right now, but if I was correcting my assertion that it said that back on April 2nd, it's been a while since I looked at it, at some point they may come back to those 503Bs or 503As and go, okay, you're compounding more than four of these a month, so we're looking at these numbers and they're exorbitantly high. These terceptide B12s, I think that could be coming, especially what I would look for is the large scale operations because we were talking earlier about the difference between As and Bs. I tend to think in my mind's eye, I think of these Bs as these big manufacturing plants, and I think of As as these quaint little shops on the corner, right? We have a compound pharmacy up the road from our house. It's just a nice little family pharmacy. But that's not necessarily how all As are. Some As look and operate a lot more like Bs, and those are the ones where I would look for the FDA to start with when they go this A route, and essentially what they do by doing that is they choke off the bulk of the supply. You choke off the Bs, choke off the big As, then all of a sudden the supply just isn't there like it once was, which will drive the cost of manufacturing and acquiring them to go up. Ultimately, then it brings that gap in what people save going the compound route versus what's available on the branded market. It has the potential to narrow that gap if that's the route they go. What are your thoughts on that?

Speaker 2:
[18:34] Yeah, maybe. I think there's a lot of merit to what you're saying. I think the original FDA statement on April 2nd, a lot of people read that and they're restating what's already there, but it's like, why would the FDA release a statement if nothing's changing? Really? That's the big question of what that means. I think, broadly, you're more negative than me. Dave's more likely to be like, is compound going away forever than I am. I think what's interesting, I toured four compounding pharmacies and I have the YouTube video almost ready. It's going to come out and you can see it. I saw a small one. I went to two mediums. I went to a large one. The average size of a compounding pharmacy is like seven employees. It's quite small. It's like mom and pops. Imagine your corner pharmacy just happens to do a little compounding on the side. It's many compounding pharmacies. Now, I also visited Empower, which is one of the largest compounding pharmacies in the United States. I think their A side is larger than their B side by physical location. I can't even describe how large the building it was because to be honest, I didn't know how to photograph it. I was like, I don't even, it was so big. I imagine like four Walmarts and then like two, two to three stories stacked on top of each other.

Speaker 1:
[19:54] You know what you should do is you should get one of those drones off of TikTok shop that follows you.

Speaker 2:
[20:01] Yeah. We need a drone to show the scale of the building, honestly, because as soon as I grew up, it was like, I don't know what entrance I'm going in. This building is so big, first of all. Then I'm not a cinematographer, I'm a little amateur content creator. I was like, how the hell do I film this? Yeah. Then for the medium-sized ones, when I was talking to them, they have more capacity. They have more capacity than what they are currently doing. But their biggest problem is hiring people and training them and making sure that standards are maintained. That's what's slowing them down. It's not physically, can our facility handle more prescriptions? It can. It's finding good people who are trained and able to compound.

Speaker 1:
[20:43] Yeah. This is essentially what the big pharmaceutical companies say about adding capacity to make the branded stuff too. It's like we can build the factories. It's hard to find the human capital to do that because it takes a special person to know how to build those facilities. But second of all, when it comes to staffing them, that takes human capital too. That's where everybody runs into trouble, which is why I think if there is enforcement on A's, they start with, and I hate to mention anybody by names, but you brought them up. I think they start with the empowers. I think they start with the strides because these are the big A operations that have the capacity to function more like a B in strictly volume of production capacity, right? And so if their goal was to really choke off compounds, that would be the way to do it, right?

Speaker 2:
[21:34] Yeah, potentially. I've also heard interesting analysis. I think you might have covered it. I don't remember. Correct me if I'm wrong around different types of B12 and B12 deficiencies. Have you covered this? Do you know what I'm talking about?

Speaker 1:
[21:49] No, I don't think.

Speaker 2:
[21:50] Okay.

Speaker 1:
[21:50] I mean, I covered the lily stuff about B12, right?

Speaker 2:
[21:54] Okay. So when it comes to B12, there I'm going to absolutely butcher this pronunciation, guys. I'm so sorry. I'm so sorry. This is such a mess. We even get the names. So there's multiple types of injectable B12. So a large percentage of the population has-

Speaker 1:
[22:14] Methylated B12, is that what it's called?

Speaker 2:
[22:16] Yeah. What's called? What is it?

Speaker 1:
[22:19] MTHFR.

Speaker 2:
[22:20] Yeah.

Speaker 1:
[22:21] A gene mutation.

Speaker 2:
[22:21] I don't know if I can say it. I've already cursed on here. I don't know if you've cursed on here.

Speaker 1:
[22:25] But the mother, mother-

Speaker 2:
[22:26] Not typically... .f-er.

Speaker 1:
[22:28] Yeah. It's what it looks like. It's what everybody thinks when they read it.

Speaker 2:
[22:32] Yeah. It's basically a gene that is linked to you having lower B12, and also if you have that, you can't just take a pill for B12 and absorb it, because the problem is your body is not absorbing B12 well. I don't know the full breakdown. We just added additives to GLP-1R, but a lot of people use Cynocobalamin, which is a synthetic B12. And if you use methylcobalamin, I'm messing this up, the methyl version, it's actually a naturally occurring B12. I think it can only be compounded. And there's some thought that if 30 to 50% of people have that genetic disposition and are more likely to have low B12, that then maybe that's the justification for having B12 and compounding. I think if the FDA goes after very large compounding pharmacies like Strive and Power, et cetera, I think they're going to sue the FDA, to be honest. That's what I think the next step would be for them if they try to shut down their ability to customize GLP-1s.

Speaker 1:
[23:38] Yeah. So do you think that that would be enough of a hedge against the FDA for them, the FDA, not to wade into those waters at all, like going, we realize the law... Because it's always been like the law is the law here, right? And pharma people can argue all day long that A's are taking advantage of a loophole, but it doesn't matter what they think, it's the law. The law allows for a doctor to write a prescription for a patient to have something compounded if it's not commercially available and the patient has a need for that. Whether you think they're abusing it or not is besides the point, it's the law. And so because it's the law, I believe what we're going to see here is the FDA's... The FDA acting as much as they can within the law, including but not limited to other means of enforcement that can be used as sort of a strong arm to get them to do. And that's sort of what I still think is on the table with ProRx. It's like, hey, you have these 483s, they're still not resolved. We come in, oh, we got some dust up here. You better stop compounding those GLP-ones. Even though the two aren't necessarily related, if it's part of their enforcement strategy or area of focus, there are other levers that they can use other than just the laws that's written around compounding to just make their life miserable. That's really ultimately what it comes down to, right?

Speaker 2:
[25:02] Yeah. And I think there's a few interesting things. I think if the FDA went for 503As and then the larger 503As sued the FDA, I think the vibe I got from watching out, watching the OFA and the compounding organizations sued the FDA after the shortage ended, I kind of got the sense of like the FDA doesn't want to be in court. No. The FDA doesn't want that sort of level of scrutiny. There's a broad trend in the United States over the past few years, where there's been a hollowing out of discretionary agencies, like the FDA and in favor of having more private litigation. However, I will say strangely in our space at the FDA, it's remained highly discretionary. I think there's almost like a fear from the FDA that if they wade too deep into those waters, they're going to lose power broadly, which then impact everything that they do. I think it's also interesting because I think the FDA, so far within federal courts, it's been a mixed bag, but a lot of federal judges see the FDA as highly discretionary. Even when you look at the litigation that I think you covered with Eli Lilly trying to get ritachotide as a biologic or not, the judge is like, I'm not going to weigh in on if it's a biologic. Truly, that's something that's discretionarily up to the FDA, it seems like is the consistent vibe that we get from federal judges. It'll be interesting to see. It's also interesting that the law that makes the FDA, the Food Drug and Cosmetic Act, is also the law that makes 503A compounding pharmacies. If we undermine that law, is there risk that it's going to undermine some of the authority of the FDA at the same time?

Speaker 1:
[26:52] Yeah. It's a really good point to bring up because I think you're right. I have the same feeling of the FDA when they were in litigation with the OFA over the shortages ending, that they didn't want to be there either. In fact, I get the same vibe with this Reddit True Tide and Eli Lilly thing, which by the way, Lilly appealed that course decision and now it's with the Seventh Circuit. Because Lilly is basically saying that in all of that, the FDA didn't respond in time and so it should default to a biologic. Yeah. I think your point is well served because you have all of this, and we brought this up several times over the last few years. It's been a while, but the Chevron doctrine, which essentially, I don't want to say handicaps, but almost handicaps a federal agency from broad overreach in policy interpretation and enforcement. So basically, they could ultimately be suiting, to your point, they lose some of their power if they lose that. So there's more at stake, I guess, is the point that you're making, and that I'm trying to reinforce here. There's more at stake for the FDA than just compound or zepatide. It's their overall authority and ability to interpret statute and enforce upon that.

Speaker 2:
[28:14] Yeah, absolutely. And I think another interesting thing when we think about the FDA changing their enforcement on 503As, the FDA inspects all 503Bs. It does not necessarily inspect 503As. Those are regulated at the state level. They do inspect 503As if there are complaints, or if they have suspicions of something going on, or if there's an adverse event like blip that comes up and they're like, we want to inspect this 503A because there's a lot of adverse events coming from there. It's on an as-needed basis. They are not going and inspecting every single 503A. To be honest, they have a huge backlog of general inspections that's been there since COVID. Because when COVID happened and they couldn't send inspectors overseas, there was a backlog of inspections that I don't know if they fully recovered from, at least not what I could find publicly.

Speaker 1:
[29:10] So this is all shaping up, I think at a minimum, to be fairly impactful to the folks who rely on compound versions of GLP-1s. In the middle of all of this that we have going on between the FDA and these compound pharmacies, we've got this litigation, hundreds of lawsuits at this point between Big Pharma and telehealth operators or compound pharmacies, even little mom and pop. There's a lot of, surprisingly a lot of little mom and pop med spa type places that are in litigation with Novo Nordis, just hundreds. But one of them, you and I spoke about on a live stream or a video that we did, what was that, two weeks ago, maybe?

Speaker 2:
[30:01] Yeah.

Speaker 1:
[30:02] That where you updated us on the Lily and Mochi lawsuit, and you had been physically present at that hearing. And this obviously has a lot of the reason that we want to follow this is because this has a lot of cascading implications for telehealth and compounds as well. So there's assaults on all fronts. There's many battles going on in the larger war against compounds. This is one of them. And as you said back two weeks ago, you said, I think this one is starting to turn a little bit in Lily's favor. Well, news came out yesterday with some court filings that that lawsuit will proceed. And that's on almost all of the complaints that Lily brought, sans maybe one of them, that case will move forward. Tell me how that plays into this broader impact on telehealth access and compounds.

Speaker 2:
[31:02] Yeah. So what's interesting is that the judge, when they wrote their order that was denying the motion to dismiss, literally ended it by saying, discovery is open, right? Which has been what these telehealth have been trying to avoid this entire time. They don't want discovery. They don't want Eli Lilly subpoenaing all of their, you know, prescription information and their internal conversations. And to be honest, I don't think this is going to go well for Mochi.

Speaker 1:
[31:27] Can you tell people why? Tell why don't telehealth, you know, like not everybody is going to be able to read into it that far. Why don't these telehealth want discovery? And why don't they want Lilly to have that information?

Speaker 2:
[31:38] So first of all, they don't want Lilly to generally have their number of prescriptions or anything like that, because then that gives them concrete data for harms. If Lilly is claiming that they are losing out on prescriptions, I think they also just don't want them in their business. They don't want scrutiny on is this mass compounding or not. They don't want scrutiny on is this customized medication or not. There's an element. And so what's interesting about the Mochi case is there's three parties on the Mochi side. There's Mochi, the telehealth, which is a software company. There's their provider group, which is like a group of clinicians that's technically a different corporate entity. And then there was Equita, their pharmacy that I think is no longer operating. And so because there's these three groups, and I would say in the industry, there's like this type of hot potato that happens, right? Where the compounding pharmacy is like, well, we can't even make a GLP-1 until we have a prescription for a GLP-1. And the doctor has verified that this is customized, right? And then on the doctor level, they're like, well, in a private conversation with a patient, I determined that this was actually medically necessary. And we've had the least amount of scrutiny on the doctor's discretion at this point. It's sort of hot potato from the compounding pharmacy to be like, well, we made this medication because the doctor asked us to make it. And the doctor being like, well, this medication is justified and the compounding pharmacy is offering it. Right? So it's like this weird whose fault is it that this is or isn't customized enough or like whose fault would it be? Is it the pharmacy who's making the medication or is it the doctor who's some would argue in correctly prescribing it to not the degree that it is customized?

Speaker 1:
[33:17] Very interesting. All of this is going to be very interesting to watch unfold, but it's suffice it all to say, there are so many battles going on for accessibility and we're seeing big pharma defend its intellectual property to the hilt. And I think it's going to be a very tumultuous time if you're somebody who has relied on compounds. And like we covered on our podcast yesterday, the battle is already raging for ritatratide or ritatratide or however you want to say it. It's already raging for that molecule so that compounders are never able to touch it to begin with. And I think that this is all, it's bad for patients because there are just, there's simply too many people who need these medications for Lillian Novo to meet that demand alone. And you shut the stuff all off overnight, they'll just be in shortage and then we're back to square one where the 503Bs fire up. So we're in a weird regulatory position where, where there's no regulation that even makes sense to deal with the issue that we have, right?

Speaker 2:
[34:26] Yeah. Well, my concern, I've heard a lot of people say that even I think like David Ricks, the FDA's CEO, I think you covered said that they couldn't handle the demand if there weren't compounding options. But I think functionally if that happened and there was a shortage, it would probably have to be very painful for the FDA to bring back the shortage because they reopened the entire can of worms that all of this had. I think there's definitely been a narrative both from the pharma companies and I think the FDA started echoing that is with these new oral options, we can handle the demand. So I think it would be a push for, well, you should be using an oral version if you can't get an injectable. And to be honest, those are not equivalent at all.

Speaker 1:
[35:10] No, not even close. Arguably, the Wigovia pill is closer if Wigovia is the drug you're already on. But Foundao, forget about it. You're not going to go from any dose really of Terzepotide to Foundao and get similar benefits. It's different hormones. So I think your point is well taken. I do think that the pills are a hedge against that. And I do tend to be with you on the fact that if these do go into shortage, that it may not be a can of worms that the FDA wants to open at all. However, I do think that there is a ethical obligation from the pharmaceutical companies to, and I realize people might laugh at that statement just in general, ethical and obligations in pharmaceutical companies. But there is an ethical obligation for them to protect the amount of patients that are on these medications. And I do think there has to be at least some within those organizations that can actually see this issue for what it is. Because again, you end these shortages, whether it's declared by the FDA or not, patients are going to miss out on therapy and they will be harmed. And so there's a very interesting argument to be made in court where this will ultimately all end up in the next six and eight months, probably. Which is great for us in terms of content creation, because it's something always to talk about, right? But if the trade-off is that it's, the trade-off is definitely that it's people in the real world that have to pay the tax on all this, and it's just a frustrating spot for them to be in. Sabina, I know that you're super busy, so I don't want to keep you much longer, but I also know that you are facing what many of us have had to face before, and that's losing a TikTok account that you've worked really hard to build. Can you tell everybody where they can follow you, or where the best place to follow you is right now?

Speaker 2:
[37:09] Yeah, so I'm Lollipop on all platforms. I'm going to start doing more long-form YouTube, because there's more I want to talk about that I can't talk about on TikTok, right? My TikTok, almost 40,000 followers got banned. My new TikTok is sabinawinwi and glpwinner. So please follow me on my new TikTok or any of my other platforms. I also have a Substack. My longer form content goes on YouTube and Substack. So I really appreciate the shout out. Always great to be on your show. I know you've been going live for hours already.

Speaker 1:
[37:47] I know. I feel like I have been on live for a very long time. But I just want to acknowledge there are 722 people watching this live stream right now. If you are not following either Sabina or myself, just take a moment to do that quick on whatever platform you're on, whether you're watching, I think there's 400 watching on X. Make sure that you're following both of our accounts there because I follow the news in GLP-one. Sabina is on top of this type of stuff, which is why every time something happens in the accessibility world, especially with Compound, the first person I want to talk to. In fact, the first person I texted when I had heard this was Sabina, because Sabina is plugged into all of this better than anyone. A lot of that is due to the fact that Sabina runs a website called glpwinner.com. This is not an infomercial for GLP Winner, but if you haven't heard of GLP Winner, it's a really cool place where you can go compare providers. There's a lot of pharmacy information on there, which I think there is, right?

Speaker 2:
[38:52] Yeah, there's a ton of pharmacy information, like what ad is they use, if they're licensed in your state, what pharmacy a telehealth uses, reviews for both of them, transparent pricing across all doses. To be honest, I just thought the shopping around process was awful and wanted to make it more transparent for everyone. It's a great place to compare if you're looking for GLP-one options, we do name brand and compounded. Yeah.

Speaker 1:
[39:16] So check out glpwinner.com. It's a really cool resource, really cool what Sabina is doing. But because she does that, she knows everybody in this industry. So she's usually the first to know. Make sure you give her a follow because she's great at keeping you up to date on all of these types of topics. Sabina, thank you for hanging out with me a little bit today and doing this on the fly. I know you're busy, but I appreciate you taking some time because this is a big deal and people need to be prepared, as I always say, so that they can have more competent conversations with their doctor if you're going to face potentially losing access to your medication. You have to work with your doctor. You have to have a backup plan and you have to be informed if you're going to do that in the best way possible. So thanks for helping us out with that mission today.

Speaker 2:
[39:55] Yeah, thanks so much for having me. It's always fun to talk to you. Follow Dave if you don't. He does all the news on GLP-1 and I just do some interesting stories that I have time for related to access. But I am so busy. I rely on Dave for a lot of the news sometimes, but I don't have time to pay attention to everything going on. So, definitely. I appreciate that.

Speaker 1:
[40:16] I appreciate that. Well, thank you very much, friend. We'll catch you on the next one.

Speaker 2:
[40:19] Yeah. Thank you.

Speaker 1:
[40:20] See you.