Transcript: On The Pen Interview with OFA Chairman, Lee Rosebush

Friends of On The Pen, we have an extremely important conversation today that we are very excited to bring to you today. Of course, you know, if you've been following along with On The Pen, we have been following the lawsuits going on in district court down in Texas very, very closely in terms of how this could affect future availability and accessibility to compounded versions of tirzeapatide and now semaglutide as well. Of course, that lawsuit brought into into the courts by the Outsourcing Facilities Association, which represents 503b outsourcing facilities. Today, I am super excited to bring you a conversation with Mr. Lee Rosebush. Lee is the chairman of the Outsourcing Facilities Association. And this conversation has been some time in the making. And I'm super excited to introduce you all to Lee Rosebush. Lee, welcome to On the Pen. Thank you. Great to be here. Yeah, really, really appreciate this conversation. I know the community of the tens of thousands of people that are relying on compounded versions of GLP-I's are eager to hear from you this morning. So Lee, one of the big things that I think is really important to set the stage is this fight over the future health and vitality of GLP-I. compounded medications in general is a fight that's very near and dear to your heart and definitely transcends the GLP conversation. Can you give us a little bit of background about why you're so passionate about the place and role that outsourcing facilities play in our health care system in the United States? Sure. And thank you for that. You know, it is something that's near and dear to my heart. For those that don't know me, I am a pharmacist by training. I'm a doctor of pharmacy and still hold my license in a couple of states. I have a law degree, obviously, and an MBA and a master's in finance. It just means I went to school way too long. But the reason why I say that is I've been in and around compounding pharmacy now and pharmacy issues for about twenty years, most of it here in Washington, D.C., at the federal policy level. And in doing so, you know, I've always tried to advocate for pharmacies themselves, right, and to ensure that patients and providers have access to the medications they need. What I haven't really often said is that, look, as a personal nature, in my own personal family, I have seven children. one of my daughters in fact my oldest daughter was born with a kidney disease and because of that she's been treated and spent plenty of time at the with the folks at children's national and that's a huge shout out to them because the folks at children national do a great deal and and seeing her struggles and seeing her treated over the last decade plus I came to realize hey there's a a true shortage and a true issue out there with drug shortages And, you know, in a personal side, we had to spend some time, even with somebody with my connections from that perspective, going out and finding medications and making sure that she had the medication needed to treat her diseases. And in doing so, we realized the importance of pharmacy compound. And so about ten years ago, I formed this trade association called the Outsourcing Facility Association, or the OFA. And as you mentioned, we're the trade association for large compounders or 503b's. We are the folks who register with the FDA We're the folks who compound using the same standards that Novo and Lilly use or any other drug manufacturer. It's called current manufacturing practices. We're the same folks that if you want to find out something about us, we're as completely as transparent as we can. We, for example, have all of our inspections on the FDA website. We have to report our adverse events, et cetera. And from our side of the things, it's been interesting over the last two years because what we've seen is the folks at Pharma, at Novo and Lilly, and even some in the media, really conflate all pharmacy compounding together and in doing so right I'm hoping that we you and I can have this conversation and also have some of the conversations with other folks in the media so that way they understand look there are different levels of compounding pharmacies and the folks that we represent are registered with the fda are making their products at the same standards are reporting adverse events when they have and we're really here to help drug shortages Just like with my own daughter from that side of it. Yes, this touches on GLP-I's. And yes, it's extremely important to ensure that patients have access to the GLP-I medications that they need. And it's important that we discuss on the cost and other access issues. But this issue goes well above and beyond just drug shortages, as you pointed out. You know, if you look at FDA's drug shortage list or you look at ASHP, which is the American Society of Hospitals, They also have a drug shortage list. There are over three hundred substances that are on that drug shortage list, many of them being kids drugs, right? Kids cancer drugs, for example, IV saline solutions, for example. And those are all things that we as OFA members make in addition to this GLP-ONES. And one of the things I would like to get across just for all your members out there so they can kind of get an idea of this. And for those in the media, go to our website. Our website is www.FiveOhThreeBees.org. And what we do is if you go on that website, whether you're a five or three member of OFA or not, we put you up on that website. We put all the drug shortage products they make and we give free access to be able to call. So that way you can pick up the phone and call that five or three to find out how you can get access to those drug shortage medications. So I want to make sure that gets out there. In addition to our conversation today on GLP ones, I know that's extremely important for your folks. But as you pointed out, this topic goes well above and beyond just these two medications. Appreciate that background, Lee. And I, I, I a hundred percent agree this, this conversation definitely transcends GLP, but because GLP and obesity impacts so many Americans, I believe that the opportunity to shine a spotlight on this and raise awareness of the broader issues of the role that five Oh three B's play in our healthcare system is, is ripe. And so, and so now I think is a great, a great time to sort of spotlight what what outsourcing facilities associations do. And you touched on a couple of things that I think we were very quick to get to the bottom of it on the pen. If you go back to April of of last year, you know, I spent a good deal of time just unpacking the difference between five or three A's and five or three B's and helping people understand that there is a difference and there will come a point where all of this stuff sort of gets conflated as the same thing, whether we're talking about the far reaches of the internet and gray market, which has nothing to do with compounding, but it's all getting conflated with Anything that is non-branded, essentially, where, as you pointed out, five or three beef outsourcing facilities are subject to the current goods and manufacturing process. There is FDA oversight there. And so they're not all created equal. That said, Lee, I think one of the things that I have been finding most ironic about this campaign against compound pharmacies is. going on sort of originating from Novo Nordisk and Eli Lilly is that when you shut down the five Oh three B compounded versions, the essential copy versions of these medications, they're really going after arguably the safest non-branded option out there for patients. Do I have that correct? You have a completely correct. And that's what the ironic thing about this is. And unfortunately I would say the sad thing about this, is that this has been wrapped as a patient safety issue related to compounding. However, when you really take a look at what's been said, and I'll give you a good example. I'm going to Jackson, Mississippi just tomorrow for a pharmacy board hearing on this issue on something that was raised by Novo. And what they're concerned about is something that they call B to an A. In other words, a five-way three B compounds a product and provides it to an A for dispensing. The reason why that is done, as you pointed out, there's a difference between a five-way three A and a five-way three B. The easiest way to think about is a five by three is your mom and pop independent pharmacy, your CVS, your Walgreens, right? Your hospital pharmacies. They make their products and rightfully so because it's based on individual patient prescription at USP or what we call United States Pharmacopeia standards. Now, those are lower standards. FDA has said so. You can look at the filings in our court cases that you and I are talking about. You can look at guidance documents. Scott Gottlieb himself has put quotes out that we're happy to put up. We put them on our website. Dr. Hamburg, Dr. Hahn. In other words, the last three FDA commissioners have all said the exact same thing. It is safer to get a product from a five by three B than it is from a five by three A. Because as you pointed out, 503b's, my members, we use the exact same standards that Novo, Lilly, Tava, Pfizer, etc. going down the list use it to manufacture their products. So for my own kids, for my daughter Sienna that you heard me talk about from this perspective. If we are injecting a product into them, I would prefer it be made at CGMP. Five with three Bs make their product at this point. So the actions they have taken, Novo, Lilly, and FDA, when it comes to GLP-Lin compounding is to say, hey, we need to take it off this FDA drug shortage list. We want to stop the five with three Bs from making the product. Ask yourself, if a five with three B doesn't make the product, who will? A five with three A. Do you want the product made at the higher, safer level? Or do you want the product made at the lower level? And then ask yourself if you had to inject it into yourself or your child, which would you prefer to have? And so it's sad because this has all been wrapped as a patient safety issue. Yet their actions have taken away the safest route. Definitely. So let's I and I appreciate that background and to know that we're sort of on the right path there. Early on, one of my one of my little catchphrases when I was trying to help the masses sort of understand the distinctions between the different pharmacy options that are out there was I always said five or three B or it's not for me. You know, I just there's the level of oversight. We're talking about injectable medications here. And and the more Oversight there is in uniformity in in oversight. I think that's where what it really comes down to, in my opinion, is you have the five or three A's that are governed by state boards. But but there's a level of federal oversight to five or three B's that just doesn't exist with five or three A's. And so so I appreciate you sort of validating sort of where we've been on that for the last about year year and a half. Now let's talk about, because we've got a limited amount of time here, let's talk about yesterday's ruling. So essentially the way that I read what happened yesterday is both the Outsourcing Facilities Association and the FDA slash Eli Lilly were all in agreement. Let's dismiss this case down here in district court so we can sort of move on to the appeals court and sort of let that process play out. And sort of Interestingly, the judge came back and he's like, no, no, we're going to proceed with a with a what's what's the ruling? You know, oral hearings and summary motion judgments for the- Yeah, yeah, the summary judgment, right? Okay, so let's talk about that decision yesterday. Do you see that case going on as potentially a good sign from this judge who tends to have seemed to not want anything to do with this up until now? Or do you see it as a bad sign, sort of neutral? How are you interpreting what happened yesterday? You know, it's the interesting thing, right? And I think this often gets lost. I think it's even lost by the judge. A lot of people don't realize, the OFA, while I spend some of my time in DC, I spend a lot of my time in Texas. From a corporation perspective, we have offices in Dallas. We have, from that perspective, we're a Dallas and Fort Worth-based association. And if you look at what has been said by the judge, right or wrong, he's made an awful lot of comments about folks coming from Washington, DC. And I get that. I understand that, being somebody who spends a lot of my time outside of the district and spends some of my time in the district. I understand. However, I will say it this way. To your point, it's been quite ironic. If you look at the filings in PACER, right, and you go through this entire list, and look, you know, I want to be clear here. I'm the plaintiff in this. Well, I am an attorney. I'm the plaintiff. I'm not the attorney of record. So I haven't gotten to see everything, right, because there are certain things that are redacted, even for me. But from my understanding, when I look at the PACER materials, is that The FDA was the one who initially said they did not want the summary motion judgment summary judgment motions right in the situation in the PI to be decided at the same point. The judge asked for that originally. So he said, I want them separate. So the judge let them be separate. Then after he made the PI decision, which unfortunately didn't go our direction. Right. We said, hey, we want to appeal this judge. You said to put them together. All three parties came together and said, look, let's just retroactively apply that decision so we can move on to the Fifth Circuit. We want to move on to appeals. and to your point he said no and then we came back and said okay well here's why we think in the situation that it would be okay to do so and we gave all of our filings yesterday and last night he made a decision says no I think because of the the impact potentially here I want to have the summary judgment motions decided gave us a briefing schedule then he also set an oral hearing date which is ironic in my opinion because we had a pi decided without an oral hearing why all of a sudden are you now needing to have an oral hearing You know, to me, it kind of shows two things. Either one, the judge has realized, oh boy, this really is a lot more impactful than what I thought it was going to be. And it does. I mean, if you look at the numbers, right, and a lot of people haven't caught on to this. If you look at our filings, we say there was eighty million doses of semi-glutide that were compounded in the last twelve months. If you take Novo's pricing from their own website prior to the four ninety nine aspect, right, they were at thirteen fifty a month. The compounding average price is about one hundred fifty dollars a month. That's a twelve hundred dollar savings times that by eighty million doses. That's how much money financially we saved the US economy over the last twelve months. And with all the conversations at state budgets and all the conversations here in D.C. about savings and Doge and everything else, that's a huge impact. And maybe the judge saw that and said, hey, this is bigger than what I thought. Maybe he's worried about from an appeal that, oh, boy, I've got a CYA myself because he realized there's something here that needs to be appealed. I can't really say what his thoughts were, but I've never seen this before where we've ping pong back and forth where I don't want to have an appeal and I do want to have an appeal. And we've tried to make the judge happy. I'm not sure where it's going to head from here. Yeah, very interesting. I think the other interesting sort of angle on that, Lee, is not only what you saved the American economy from a pricing standpoint. Right. But when we talk about obesity and the epidemic that is obesity and all of the sort of downstream costs of treating obesity within our health care system, we talk about, you know, maybe the the the lost GDP potential. with so many people fighting chronic disease and you look at other countries, in fact, some other countries that are sort of, you know, they've sworn themselves enemies of the United States. You know, all those countries are, you know, arguably have more affordable access to these medications. And so their population, their countries are getting stronger and emboldened because their patients within their countries have access to these treatment. I think there's also sort of a national security argument that could be made also that we need to start taking the epidemic of obesity as seriously as we've taken any other epidemic in this country and start treating it as a national security issue as well. Do you kind of see that as as being something that that some ears may be open to in Washington, D.C.? I will hardly agree with you. I'd even take it a step further, to be honest with you, Dave. Right. My understanding is this current administration is about America first. We have tariffs to say so. We want to bring back domestic manufacturing. We wanted to ensure that we have a good future right from that perspective. And for years, we have heard the bad guy in all of this is the middleman, the PBMs and the rebates. And that's why we, for example, pay more for drugs here in the United States than we do in other countries. So let me ask you this. This goes directly to the heart of what you were just saying. My understanding is this is literally direct issue of a program that you could buy a product at four ninety nine a month. And so there's Novo and their direct care programs. My understanding is, is that both of those programs have explicit terms and conditions. And those terms and conditions in the situation explicitly say that if you have an insurance program or your stuff is covered by an insurance, you're not allowed to use our program. So in other words, there's no PBMs, there's no insurances involved with that. And the product in this perspective is three forty nine for the lowest dose, depending on the drug, four ninety nine and six ninety nine. Right from that side of it, depending on if you're getting a thirty or forty five days. My understanding is over the week, Lilly in this situation released product and they're selling it for fifty dollars a vial. Maybe if you want to say they have to use a couple of vials, so maybe you say just to be safe, let's say it's two hundred dollars a month cash. Why in the situation if they have no insurance and PPMs and the Lilly Derelict program has no insurance or premiums and it is the exact same product made overseas, right? Same exact pen, same exact vial, same exact drug. Why is it OK to charge us five hundred dollars a month and to charge them two hundred dollars a month when there's no PBM? There's no insurance. So this is truly an America first agenda. Explain that to me. Same thing into your side of it, one of the national security aspect of it. You can go into China, right? The Chinese in that perspective, they've got a six year head start on a generic for these products. And if they are as effective as what everybody says they are, including Novo and Lilly, that means they have a six year head start on losing weight, obesity, military aspects, military preparedness, et cetera, going down that line. The other thing that I would say in this situation, it'll be interesting to see how this plays out. Remember, Over the last couple of years, we as a country have allowed now for the importation of products through Canada. Florida, for example, right? They now have a program that was approved that allows product to be brought in from Canada. Is this something that the state of Florida could now move forward with and import that product now from Canada? So there are lots of different mechanisms here where there may be potentials here where if nobody's truly scared, they're going to have to push back on multiple policy fronts. Because if we truly care about this industry, we truly are America first. We shouldn't be being ripped off. We shouldn't be paying more than what other people are paying for. We should have access to this and we should look at some of these importation programs as well. I would prefer product be made here in the United States. I would prefer product be made in a CGMP where FDA could inspect this today if they wanted to, because all of my members are domestic. But there's lots of routes and mechanisms here where there may be access to this product. Why is there no appetite between these big pharmaceutical companies and outsourcing facilities associations to broker some sort of deal where you're supplementing their manufacturing capacity? Honestly, I tried that. I've tried that. I've had conversations directly with representatives for some of these companies, to your point, and said, why don't you partner with us? It's an easy solution, right? We're domestic manufacturers. Why can't we be your authorized generic? So when you're short on a product, you use us to manufacture the product to ensure patients and providers have access to the drugs they need. And when you're done, now we have a contract that says we're done. Right. I don't understand. To me, this is one of the biggest problems. I don't understand that other than the fear from that perspective of working with somebody who's right different. But to me, that makes the most sense. Why doesn't Novo pick a five or three B contract with them and to do this? You mentioned, for example, some of these other programs, these telehealth programs and all these types of stuff. They're partnering with pharmacies. They're partnering with telehealth programs. Why don't they partner with a five by three B who's domestically manufactured a product at the same level they are? It would help increase their production levels. A hundred percent. The only thing I can think of on the pharmaceutical side is that this campaign against compounds is bigger than GLP. I think they fear legitimizing what you do, which is to me a tell, right? As we sort of mentioned at the outset of this, you know, the way that I understand it, they were established sort of almost at, you could argue as a national security sort of backstop, right? For the explicit purpose of mass manufacturing medicines, because as our supply chain has moved overseas increasingly over the last couple of decades, it became very apparent to people in Washington DC that, hey, if anything ever gets squirrelly on the world stage, we need to have a way to make sure that patients in the United States have access to medication. So it's always been this backstop to ensure that Americans have access to life-saving and disease altering medications. And I really feel like pharmaceutical companies see that as a threat and not for the intended purpose that they were created. And you know I just think it's inconvenient for them that some of these blockbuster medications and that they haven't been able to keep up with them but but you're simply fulfilling a role which you almost have I would argue a mandate from our government to fulfill and so that's the only the only sort of plausible thing that I can come up with is just they fear legitimizing what you do but what you all do is already legitimized and codified in the law. That's exactly right. And you know, it's funny because we'll use COVID as our example, and then we can give some more recent examples. Even during COVID, when all everything, you know, excuse me, my language, but when I hit the fan, right, there was a huge shortage from that perspective of products that were used for ventilation, for treatment, et cetera. Who do you think stepped in to fill that shortage product? There's FDA guidance documents all over the place for five or three days where they asked us to be able to help make that product more recently. And I'm sure you guys have heard this. You heard about children's Tylenol shortages and ibuprofen shortages. Who do you think stepped in to make that domestically? You heard about children's amoxicillin issues. You don't hear about that anymore. Who do you think stepped in to make that product? Same thing with IV saline solutions. More recently, when we had the unfortunate situations that happened in North Carolina, the hurricanes in Puerto Rico, and you heard about all the IV bags and all the hospitals and procedures that had to stop. do you think stepped in to make that we have members who are making thirty million bags a month it's it to me it's almost like we're the folks that they want to put in the corner they need us when they need us and otherwise they don't want us there right because they know in essence we're competition and what it's been hard especially seeing the republican side now that the new administration come in is that you have some of the folks who are old school and they will understand ip protections and they understand from china and I understand that that fighter I also understand that there are folks out there, the heritage, the FBI, et cetera, that look at it to say, hey, you know, we really need competition. Markets are supposed to act from that perspective when we have free markets and competition. Right. In this situation, if we're making products, we should be able to step in and fulfill those. Do I think as a pharmacist, right, that we should be able to make every single product? No, not necessarily. I understand that. Right. But at the same time, when we're here to help fill in and when they're needed, patient access, patient shortages, let's be honest, who better to do that than domestically at CGMP, the same level that drug manufacturers make? That's why we're here. We can turn on a dime. We can turn our lines on in six weeks to six months, where pharma may take eighteen months by the time they get their validation done because of the sheer volume. Let us fulfill those needs. Once pharma is up and ready and they can do it at a mass production, that's great. Then we can step back. But we have shown over and over and over again over the last five years that when America needs us, we're here. We step up to do it. And every time we step up to do it, we get the afterwards. And, you know, at some point it begs the question, why? Why? Why? Why can you continue to do this? How can you continue to forecast or run a business model when you don't know the predictability of what's going to happen in the future? A hundred percent. We got to wrap up our time here in just a second. Two more quick questions. One can bleed into the other and just a quick answer from you. Is there precedent that potentially you could argue that cost cost is a reason to that that would sort of validate the mass manufacturing of a medication second part of that question is yesterday dr Marty Makary was confirmed as the fda director and what sort of role do you think that that shift within the FDA will either, will impact your efforts with the Outsourcing Facilities Association? You know, let me take the first one back in the precedent because there is, there's explicit precedent on cost, right? Put aside the shortage stuff I just talked about with COVID drugs and all of that. On the cost front, the easiest one, there was a drug called Makanna, It was compounded by compounding pharmacies for premature labor for nearly a century. FDA recognized that. There was a pharmaceutical company called KV just outside of St. Louis who came and got it approved. Once they got it improved, they jacked the price up thousands of percent. The March of Dimes stepped in and said, this is crazy. We're trying to help premature labor. We're trying to save babies. Why are you making thousands and thousands of dollars off something that was publicly available just recently for a much cheaper price? And the FDA put up on their website, said we're going to continue to allow Makana to be compounded or something, hydroxy progesterone to continue to be compounded. And we are not going to enforce it. That's right there. The second one from this, you had some interesting bedfellows and Senator Bernie Sanders is one. You also had some of the Republican aspects of this as well that we can point to into the drug called Avastin. Avastin in this perspective is it meant for oncology purposes. It's approved as a cancer therapy, right? It's a chemotherapy based. And some smart physicians realized that you could take basically what was an ADCC vial and you could take up less than a CC and inject that into somebody's eye. It was meant for wet macular degeneration. Probably is pretty scary for the first couple of people who had injected into their eye when it wasn't approved for it. But lo and behold, it works and it works fabulously. And it's been done for years at this point. Cerny, Banner, Sanders, and a couple of the Republicans, when they were putting together budgets and they were looking at Medicare and Medicaid, said, hey, here's the problem. Avastin works so well that so many people are going to need this moving forward that it's going to bankrupt CMS if we don't do something. The problem is Avastin is meant for singular use, right? It's a single use file. So once you pull that one CC, you basically take the rest of the seventy nine. You have to throw it away, even though you've paid for the entire eighty. So what they allow for is Avastin. They still allow for this to this day. And in fact, if you look at FDA's repackaging guidance for outsourcing facilities, there's a footnote that explicitly says this, that outsourcing facilities have the ability to repackage Avastin for use for wet macular degeneration, even though it's not approved for it. And the reason being, cost. So there has been multiple times now where FDA, HHS as well, have recognized, right, that cost can be a patient access issue. I want to be clear here with our lawsuits. I think there's a shortage regardless of the cost. That's not the reason why we're bringing this to the cost. Do I think costing to be a factor? Yes. Do I think cost is a factor? Yes. Right from that perspective. But I truly believe that there is a shortage issue first, and that's why we're bringing this. But those give you two examples where HHS and FDA, HHS being the parent agency of FDA, have recognized that on cost alone, compounding can continue. OK, excellent. You see. Thumbs up, thumbs down or neutral on Dr. Macari's confirmation as far as the future of your battle here. My understanding is right from both conversations and looking at his past that he understands our industry. And so I truly hope that this moves forward. Obviously, I have not had conversations with him. I wouldn't do that to him. Right. Recusal purposes, et cetera, from that as to prior to and when he's been nominated. But my understanding from this perspective is that he does understand it. He's got a history with companies associated with our industry who are not OFA members. I want to be clear with that. But they understand our industry and he understands the need of it. That's, you know, you mentioned this. I'm going to hit on this because it goes to Marty as well, is that, again, this compounding issue is much bigger than this, than just GLP ones. And the reason why I raised that is, is he's a physician, a surgeon. if you in this perspective have been to a hospital whether that's because you've been in the maternity ward right related to labor whether that's or whether that's er if you've received those iv bags those infusion bags you've received a compound medication I say that because physicians and surgeons obviously use iv solutions when a surgeon is going on so he knows the importance of compounding it's been going on for a century right It also begs the question of why Novo and Lilly will attack compounding and then eat for five by three bees and say we're so dangerous when literally we make billions, potentially trillions of compounds across this country over the last hundreds of years that has been used for this in this perspective. So I'm hoping with his background, right, and understanding the importance of compounding medications and IV saline solutions and all the bags he's made, that he understands the importance for us to continue to make these products. Because without us, this country would literally stop. The worst thing that could happen in all of this battle between the pharmaceutical companies and the FDA and the OFA and all of this sort of crazy dance, the worst thing that could possibly happen is that the work of five or three pharmacies would be delegitimized in the eyes of of the public opinion because we rely on you. And so kudos to what you're doing at the Outsourcing Facilities Association. We support you and what you do at the Outsourcing Facilities Association, and we We really condemn strongly any efforts to undermine the greater work that you do sort of outside of this GLP-One conversation, which is part of it, but not even scratching the surface on the importance of everything that you do. Lee, fiveohthreebees.org is where people can find you. Anything else that we can do to help you in your efforts right now? I mean, anything that your members have that shows that there is, in fact, still a shortage, we would love to have. The email address is up on that website. Feel free to reach out at any period of time. If you, for example, have gone to a pharmacy, you've got screenshots, et cetera, that show that it is in fact a shortage, we would love to have that information. Thank you for everything that you do. Again, from our side of it, that's why we're here. We're trying to fight the fight to ensure patients and providers have access to the medications they need. We want to make sure that everybody has access to the drugs that they absolutely need, especially these life-saving medications. If there's anything we can do for you or your followers, we're happy to help. All right. Lee, I appreciate your time. Thanks for giving us a couple extra minutes today. Hopefully we'll get a chance to do it again. Sounds good. Have a great one, y'all. Best of luck to you, your daughter, and all your seven kids and your whole family. Thank you. I appreciate that. Take care. Lee Rosebush, he's the chairman of the Outsourcing Facilities Association, who has brought the lawsuit against the FDA in district court in Texas over the tirzepatide and semaglutide shortages. They are fighting the fight. So make sure you check out their website, five oh three bees dot org, where you can learn more about what they're doing and their fight. We thank Lee for joining us today here at On The Pen.