#1224 Orange Book Chronicles

June 13, 2024Scott Benner

Scott Strumello is here to discuss the topic of pharma companies improperly listing patents in the FDA's Orange Book.

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Scott Benner 0:00
Hello friends, and welcome to episode 1224 of the Juicebox Podcast.

Today I'm going to be speaking with longtime diabetes blogger Scott strim. Hello, Scott and I are going to talk a little bit about insulin pricing. But we're going to talk a lot about something called the orange book and how the FTC noticed that maybe some products were on there that shouldn't have been. Now I know that might sound kind of boring and inside baseball, but trust me, this has implications on you and your family. And it's a very interesting look into how things actually work. Please don't forget that nothing you hear on the Juicebox Podcast should be considered advice, medical or otherwise, always consult a physician before making any changes to your health care plan are becoming bold with insulin. When you place your first order for ag one with my link, you'll get five free travel packs and a free year supply of vitamin D. Drink ag one.com/juice box, use my offer code juice box at checkout at cozy earth.com And you can be wearing the same sweatpants I'm wearing right now except they'll cost you 30% Less cozy earth.com use the offer code juicebox at checkout to save 30% off of your entire order.

US med is sponsoring this episode of The Juicebox Podcast and we've been getting our diabetes supplies from us med for years. You can as well us med.com/juice box or call 888-721-1514 Use the link or the number get your free benefits check it get started today with us med Today's episode is sponsored by Medtronic diabetes, a company that's bringing people together to redefine what it means to live with diabetes. Later in this episode, I'll be speaking with Jalen, he was diagnosed with type one diabetes at 14. He's 29. Now he's going to tell you a little bit about his story. And then later at the end of this episode, you can hear my entire conversation with Jalen to hear more stories with Medtronic champions. Go to Medtronic diabetes.com/juicebox or search the hashtag Medtronic champion on your favorite social media platform. This show is sponsored today by the glucagon that my daughter carries. G voc hypo Penn. Find out more at G voc glucagon.com. Forward slash juicebox. Hi,

Scott Strumello 2:41
my name is Scott Strumello. Some in the diabetes community know me because I have been a longtime blogger. I think I started back in 2005 or so my blog is still out there. It's blog.es romello.com. And I was also very active in social channels, whatever for a long time, not so much that any more are more active these days on threads and LinkedIn. LinkedIn is a little bit more of a professional social media platform. That's the reason I opted to publish my article, which I think we'll probably talk up talk a little bit about, yeah, I'm

Scott Benner 3:22
excited about that. Scott, tell me what is this what you do for a living? Or is this something you do on the side? It's

Scott Strumello 3:27
something I do on the side. But you know, by nature? I'm a very curious person. And, you know, I was curious why, you know, originally it was about biosimilar. insulins back in 2006 or so is of some five 2006. I raised the question, all the patents on these products have expired, why don't we have generics? And I wrote kind of a multi page article on that subject. And there were a whole bunch of reasons why it wasn't happening like it should have. Most of those issues have since been resolved. Most recently, in 2019, when the FDA made a policy decision to recognize any insulin that had been previously approved as a drug under the Federal Food, Drug and Cosmetic Act, which all insulins up until that time had been regulated under they would recognize them as a biologic and therefore they would be eligible for biosimilars for the very first time ever. And with that, you know, companies started pursuing them. And along the way I happened to notice because my interest was in the insulin. All these companies also have biosimilars of the GLP one inhibitor. liraglutide, which was formerly known as Novo Nordisk Victoza, then a couple of years ago after it was introduced, they got an FDA label extension for the indication of obesity without type two diabetes. And they branded that version six, and it's the exact same drug. It's just got a different name, and they're selling it to different people.

Scott Benner 5:18
Okay, so you wrote this article. So listen, let me I'll tell people like I, you and I, we we talked before, we're not sure if we've even ever met maybe once in a blogging conference, you know, 15 years ago or something like that, but we don't know each other. But I follow you on LinkedIn. And I think of you as this curious intelligent person who asks a lot of questions that I find myself asking like, why is this like this? How come that's not cheaper? Why is this not available? Like and I love the way you ask them and then follow up with you know, these are probably the reasons why. And it is a part of life with diabetes that I mean, as the regular layperson does not have time to figure out what's going on here. Right, like so these things happen behind the scenes and you don't know why you're being impacted in your real life. Yeah, go back to the insulin for a second before we move to the GOP. Now that like you know, I'll be a little like, I don't know how this will come off but like you know, in the last year or so, the pharma companies have been saying about insulin like oh don't worry the price is going down I'm like you know the price is going down because you're about to lose hold of it like it's not like you know what I mean like they held a death grip on it till the very last second and then they tried to act magnanimous about it at the end. If you take insulin or sulfonylureas you are at risk for your blood sugar going too low. You need a safety net when it matters most. Be ready with G voc hypo pen. My daughter carries G voc hypo pen everywhere she goes, because it's a ready to use rescue pen for treating very low blood sugar and people with diabetes ages two and above that I trust. Low blood sugar emergencies can happen unexpectedly and they demand quick action. Luckily, G voc hypo pen can be administered in two simple steps even by yourself in certain situations. Show those around you where you store G vo Capo pen and how to use it. They need to know how to use G Bo Capo pen before an emergency situation happens. Learn more about why G vo Capo pen is in Ardens diabetes toolkit at G voc glucagon.com/juicebox. G voc shouldn't be used if you have a tumor in the gland on the top of your kidneys called a pheochromocytoma. Or if you have a tumor in your pancreas called an insulinoma. Visit G voc glucagon.com/risk For safety information.

Scott Strumello 7:43
Yeah, I mean, and there, there is some truth to that, like anything in pharma, it's always a little bit more, you know, it's a little bit more complicated. There's the way I've described my discovery process and how the pharmaceutical industry works. It's kind of like peeling a head of lettuce apart. You peel one leaf, and then there's another one and another one and another one. And you think I'm never gonna get to the frickin answer. And, but eventually you get to the core. And you're like, Okay, that makes sense now, but there were just layers and layers and layers of, you know, weirdness, you know, things that you're like, do businesses really operate this way? And I'm like, yeah, if you're a pharmaceutical company, they do. You know, my, my journey began years ago, back when I began blogging around, I don't know, I guess, like 2005 Maybe I'd have to go back and look at when the first post was. But the good thing is, I was able to find or discover some people that were, I considered very informative on the topic, and I followed them very closely. Lo and behold, they were consistently correct about different things. And, you know, I was like, Okay, so that's why this happens the way it does, it was kind of a fascinating journey of discovery, I guess. But once I once I knew all that, then I could kind of piece together okay. So, this is why insulin is priced the way it is. And most of it is not because Lilly Novo Nordisk, and Sanofi are choosing to price them through the roof. But it's the way that they choose to sell their insolence, the commercialization path, they decided to go for this big PBM rebate contracting sales model, whereby they start with Sky High list prices, and then they give rebates of 90% back, and so it looks like it's generous. But really, the only reason it's generous is because they raised the price so high in the first place that they could discount it all back on the back end. So that's kind of the The story with insulin, can

Scott Benner 10:01
I ask you a question? What's the business benefit of that? Like, why is it presented that way? What does it do for them?

Scott Strumello 10:09
You know, there are a couple reasons, all of them which I feel, which I would say are actually legal. I don't even know if they are legal. But the PBM has basically made a sales pitch to the pharmaceutical industry that said, Look, we represent hundreds of millions of customers, you wouldn't have access to them without us. But guess what, we'll throw you a bone here. We'll keep off your biggest competitors off formulary, they won't be covered. If you pay us a kickback or illegally exempted rebate kickback. And so that was basically how they operated in order to were pharma to avoid truly competing on the products merits. They pay a little bit of extra money to the PBMs to keep their rivals off formulary. And lo and behold, you don't really have to compete on the products merits. Yeah, it's based on the kickbacks that you're paying.

Scott Benner 11:09
Well, that makes sense. Okay. So I'm not sure it does. I mean, it makes sense that that's what they did. Yeah, by me, based on what I saw it because you know, when people's regular life, they'll say all the time, like, Well, my doctor wrote a script for x. And I gave it to my insurance company. They said, we don't cover that, but you can have this. Yeah. And then you go, okay, and that's the end of it. But on the back end, whatever you ended up with, is paying a vague, so that you don't have access to the other thing.

Scott Strumello 11:37
Yeah. And also, there's, you know, there's a little bit more about it, you know, not only are you being told this as our preferred product, but they're saying we're not even covering the non preferred product. If you go back to the early 1990s, when Pharmacy Benefits started to become a thing, because it wasn't until the early 90s, that health plans even had pharmacy benefits. Prior to that it was all like cash out of pocket. Yeah. And so it sort of evolved around the same time. But, you know, keeping your rivals off, formulary became a very powerful pitch and the rebate kickbacks certainly helped help do that. But I think somewhere along the way, I think it probably started happening around 2016 or 17 or so. That's when Novo Nordisk reported to investors via its SEC filings that its US insulin margins had fallen into the negative territory. In other words, they were no longer earning money. They were still earning money, but they weren't. The growth was negative. So in other words, and most of that was because of rebates. They were paying to keep Lilly and Sanofi insulins off formulaire then a couple years later, Lilly decided, you know, we're going to be benevolent here and we're going to, we're going to sell a cheaper version of human log, we'll call it insulin lispro. We'll sell it under the generic name. And that was a good thing because prior to that, either got the heavily remitted kickback driven priced product sold through the P VMs. Or you paid $400 via you know, it was kind of crazy.

Scott Benner 13:28
Can I ask you a question? In retrospect? Was it the right thing for them to do financially? Or did it end up biting them in the ass at the end?

Scott Strumello 13:35
Actually, what happened was when Lilly did this, I think they were a little surprised at the extent to which the unbranded humanoid product sold, like a year after they introduced Lilly insulin lispro injection, it accounted for 1/3 of us human log sales. Like overnight, you know, it's practically they did no marketing of this product. And nearly a third of their sales was the cheaper version. And I think at that point, that was when Lily said wait a minute, we don't need the PBMs to sell insulin at least we can just sell it ourselves and say screw the PBMs we're not paying the kickbacks anymore. So that embolden them to say it to the PBMs Fu, we're not playing your your kickback game anymore. At least for the insulin therapeutic category. We'll just sell it on our own. Our customers are happier. It cost us billions of dollars less money, and we earn more money so it worked out for them. Lilly did it and then like two weeks later, Novo Nordisk did the exact same thing. And then Sanofi was sort of forced to do the same. I don't I'm not sure about Biocon. They're kind of a smaller player right now. But basically, that's kind of the deal with Is that Lily, because they learned that the PVM was were adding no value. And also there, there's another little not so little law that got passed by Congress, which was called the American rescue plan of 2021. The American rescue plan of 2021 contained a little teeny provision that I don't think anybody even paid any attention to at the time, but basically what it said was for Medicaid, not Medicare, or Medicaid, we will no longer allow Medicaid to reimburse more than 100% of the average manufacturer price. And if you charge more than the average manufacturer price, you'll have to pay us Medicaid to get your drug listed on our formulary. And so that really tied Lily noble Novo Nordisk can sign off his hands because these were old, patent expired insulins that were heavily rebated and suddenly they were faced with the prospect that they would actually be forced to pay the federal government in order to get those products listed on the Medicaid formulary. And so the only resolution for that was to slash prices. So without also embolden them a little bit to kind of say, you know, we don't need the PBMs for this, and we'll move on.

Scott Benner 16:29
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Scott Strumello 18:08
it was Yeah. But that's very much the product of the PBMs not wanting anyone to know about their little kickback scheme, which by the way is not such a little kickback scheme. It's the last number I had, it was more than a quarter of a trillion dollars a year in rebates across all drugs. So

Scott Benner 18:26
they jack the price up so that they can skim. It's not it's you know, they take a piece of it. And that piece ends up being a quarter of a trillion dollars. Yeah,

Scott Strumello 18:38
it's not just the PBMs. The PBM is our big, big motivator behind it. But a lot of the PBMs which are one in the same with the insurance companies, the United Healthcare optimara civica, Express Scripts and Aetna CVS Caremark they're all one and one together. In other words, they're, they're vertically integrated with these insurance companies. And so they, you know, it hits the bottom line of the insurance company, not the PBM, per se, what they were doing is they were basically saying, We'll give you a discount on your premiums to employers, they were saying, We'll give you a discount on your premiums, we'll call them premium offsets, all that money was coming from PBM rebates that were paid to them. So in other words, to sell more insurance policies of taking money, which is intended for patient relief, and instead giving it to sell more policies. I mean, you couldn't make something up more complex or more convoluted than this. I mean, it's insane. I

Scott Benner 19:47
got a headache thinking about the last time I tried honestly, it's why I appreciate somebody like you who can sit down and just thoughtfully remember it. How much reading Do you think you do on this? These things so I don't

Scott Strumello 19:58
do so much More I used two years ago. And this is, you know, the accumulation of years of reading and knowledge on this topic. You know, after a while, it's just sort of sticks with you.

Scott Benner 20:11
Well, alright, so let's kind of jump ahead to the article you wrote that I saw recently tell me what prompted you to write it and give people an overview of what it's about.

Scott Strumello 20:20
I don't even remember what the title was. It was kind of a long one. Give me a second. I have it here. But basically, the article was basically how the Federal Trade Commission, the FTC, had taken some action on April 30 19, or 2024. I was saying 19 and go back to my blog start here. And basically, the FTC acted, and they basically said, look, to the pharmaceutical companies, they first did it back in November of 2023, for epinephrine pen injectors, and also for asthma inhalers. And basically, what what was happening was the drug industry was listing patents for medical devices. In the Food and Drug Administration's Orange Book, which is a listing of drugs that is voluntary, terribly populated by the drug industry, the FDA doesn't really take a very hands on approach to managing. But what's written in the law is that only the drug or the biologic medicine is permitted to be listed in the FDA Orange Book, not the device. So you may sell an epi pen, for example. But the pen itself can't be listed. Only the epinephrine molecule can be listed. And so last November, they said, We're going to challenge a bunch of these inappropriate patent listings on the food FDA Orange Book, and they were able to do it successfully. And that got them to thinking there's probably other drugs that we can do this floor and wall up. Here we are GLP, one inhibitors being the hot drug of the moment. And a bunch of inappropriate patent listings for those products were listed inappropriately in the FTAs. Orange Book.

Scott Benner 22:22
Let me tell people what the orange book is. And then we'll ask why there an appropriate FDA Orange Book is an authoritative reference that lists all approved drug products providing information on their therapeutic equivalents, patents, and exclusivities. It helps healthcare providers, regulatory authorities and generic manufacturers by detailing when generic versions of drugs can be legally marketed, the book ensures a balance between protecting drug innovation and promoting market competition to make medications more accessible and affordable. Is that something you agree with?

Scott Strumello 22:52
Yeah, absolutely. Okay, a little loan factoid about that is when when drug companies list a list a patent in the orange book, that means that any company that wants to sell a copy of those medicines, has to wait 30 months or two and a half years before they can even be considered, the FDA will not consider the drug application for 30 months. And that's kind of what happened here by inappropriately listing 10 injector devices or the GLP ones. That's not the medication, that's a medical device that's regulated separately.

Scott Benner 23:32
So why did they do that? I know the answer, but it's because the molecules older it's going to run off patent sooner. So they were trying to squeeze more time out of it. Do

Scott Strumello 23:41
you think they were although they did it for their newer their newer ones too, as well, I think and they could kind of argue well, it was a sleight of hand, you know, we sell them in pen format. And so you know, our bad sorry. That was basically what Novo Nordisk would say to the FDA about its inappropriate patent listings for these drugs. But in fact, you know, I think they were consciously doing it trying to get another two and a half years before any generic or biosimilar could come to market, right? Because these GLP medications are forecasted to be huge for some of these companies, right? Yeah. In fact, I just got something the other day that was kind of interesting. It's a fairly new report from the analytics firm known as global data that predicts that sometime in 2020 for the GLP. One inhibitor class of drugs, is poised to become the top selling drug category based upon existing drug sales. The current sales leader is a class of drugs known as PD one inhibitors, which is a type of targeted immunotherapy used in treating certain types of cancers and in my reaction to that as toppling overpriced cancer drugs to become the best seller is no small undertaking. But we can go back to Novo Nordisk earlier FDA label extension for its first generation GLP. One known as liraglutide, which was branded originally as Victoza for type two diabetes. 10 years later, they got an FDA label extension for the indication of obesity without type two diabetes. And they branded that one saxenda. They're the exact same drug. It's just the ones once prescribed for obesity and ones prescribed for type two diabetes. All of those are patent expired. And so what Novo Nordisk did is they, they did make legitimate improvements to them. I mean, it's not these were brand new molecules, in essence, then they took the old products off the market, and they tried to prevent anyone else from selling copies. Oh, really? Of the saxenda? Yeah. Oh, so they had something that worked reasonably well. They improved on it made something that works better, and then went, how did they block people from making the generic of sex ENDA? Well, the first thing they did was they inappropriately listed patents in the FDA Orange Book, which were not for the drug or biologic itself. But were for medical devices, pen injector devices. They were like a whole bunch of them. 36, I think was what the FTC counted, and said, these are all patents for devices. You can't list those in the orange but only the biologic or the drug and be listed in the orange book. So by doing that, Novo Nordisk could have said, well, we was a mistake are bad, you know, but by listing them, they automatically got themselves another 30 months of keeping a biosimilar off the market. So the first thing the FTC, the Federal Trade Commission, did was they disputed all of these inappropriate patent listings, which were not for the medicines, but most were the devices that that the medicines were dosed in. And they said, You can't list these, the statute says, you can only list the drug or biologic not a device. So the FTC went to the Food and Drug Administration and said, We have a long list of patents that we think are inappropriately listed. And we want them to you know, we're calling them into dispute, and we want them removed from the orange book and lo and behold, 36 of Novo Nordisk six patents on various GLP one inhibitors, Victoza? saxenda. And what's the newest on semaglutide? Whenever they're brand new, that

Scott Benner 27:53
was epic. Xebec. Okay,

Scott Strumello 27:55
it was epic. And there we go. They have another one for weego. The Yeah. So all of those products, they listed. patents were the devices. That's a no, no, right. The statute doesn't allow to do that. Yeah.

Scott Benner 28:07
So let me ask two questions here. So first of all, that's not what the orange books for now. Okay. But secondly, let's play devil's advocate for a second be fair to them. There's there's something incredibly special about their injections devices that they'd want to protect. Sure,

Scott Strumello 28:22
but you don't do it, listing it as a drug that automatically gets a 30 month stay. The medical devices are regulated under a different division of the Food and Drug Administration. And they have their own listings.

Scott Benner 28:36
So for clarity for people, if they thought there was something so special about their injection device that they wanted to patent that they would patent that device as a medical device, and not tie it to the medication that was inside of it.

Speaker 1 28:48
Correct. Okay. But they did. And

Scott Benner 28:52
that buys them this two and a half years. Correct. Gotcha. The FTC notices and goes and no, you know, doing that. Exactly.

Do they have the power to stop it?

Scott Strumello 29:03
The FTC has the ability to file a complaint with the Food and Drug Administration saying the following list of patents is inappropriate. And they did it for like 360. So far, it's not just insulin or, or GLP ones. It's not just this company can. But they did it for over 300 patents that were inappropriately listed. And that's probably just scratching the surface. There's probably a lot of others. They

Scott Benner 29:33
went after Lily from Jarno and zap bound pens, did they do it as well? Or did they not do it?

Scott Strumello 29:39
They didn't do it for Lily on Manjaro or zip on. But what they did do is for a former Lilly product, which specifically was the glucagon rescue kit, and I can't remember the name of it's the inhalable

Scott Benner 29:54
one max, max semi now. Yeah,

Scott Strumello 29:57
I think yeah, yeah. So Oh, Lily had listed patents for a drug delivery device for back see me on the orange book. And that's also a no no. However, then

Scott Benner 30:10
it's a little tube that you squeezing it puffs out.

Scott Strumello 30:14
Yeah, yeah. And they're technical specifics in there that are patented.

Scott Benner 30:20
I'm sure it's like,

Scott Strumello 30:21
I'm sure. But anyway, Lilly decided we want to get out of the glucagon business as commoditized. We don't make any money. They sold it to a company called amphastar pharmaceuticals about a year ago. And so now it becomes amphastar problem, even though Lilly was the one that inappropriately listed those patents. But I think what's interesting about amphastar is even though they got slapped on the hands for the back seamy inappropriate patent listings, they on the other hand, got a big gift from the FTC because amphastar pharmaceuticals also happens to have a copy of liraglutide now pending FDA approval. So in other words, their copy of Nova donors sex ENDA or Victoza can come to the market even sooner. So the Lord giveth with one hand and taketh away with the other is kind of the way that I look at it. I suspect that for amphastar, the sales of the biosimilar version of liraglutide probably will make up for any losses they took on vaccine me Yeah,

Scott Benner 31:26
so the reason that this are the article you write catches my, my attention so much is that I mean, besides the fact that at the moment, I have to pay cash for my daughter to use a GLP that she needs. And I'm interviewing people who have type one diabetes, type two diabetes, just for weight loss that are benefiting insanely from this, but they're also talking about having to run around like crackheads looking for this medication and they're paying out of their pocket some $1,200 a month, sometimes I don't pay that much for Arden out of pocket, because she's only using such a tiny little bit of it that we just need one pen to get her through for a while, like that kind of thing. But it's still expensive. I don't want to say that it's not. Yeah, and there are studies coming and going on right now that are going to apply GLP medications to people with type one. And I think that all of this little tic tac bullshit is going to slow down from people getting this medication if they need it. And it sits with me so poorly, that the idea of like, well we can hold off biosimilars by because that's what this really is about, right? Like right now, our big problem is what there's companies who are poised to do this, but they're being held up by the patenting of the injection systems is that right? There. This episode is sponsored by Medtronic, diabetes, Medtronic diabetes.com/juice box. And now we're going to hear from Medtronic champion Jalen.

Speaker 2 32:53
I was going straight into high school. So it was a summer, getting into high school was that particularly difficult, unimaginable, you know, I missed my entire summer. So I went, I was going to a brand new school, I was around a bunch of new people that I had not been going to school with. So it was hard trying to balance that while also explaining to people what type one diabetes was, my hometown did not have an endocrinologist. So I was traveling over an hour to the nearest endocrinologist for children. So you know, I outside of that I didn't have any type of support in my hometown.

Scott Benner 33:26
Did you try to explain to people or did you find it easier just to stay private? I

Speaker 2 33:31
honestly I just held back I didn't really like talking about it. It was just, it felt like it was just an repeating record where I was saying things and people weren't understanding it. And I also was still in the process of learning it. So I just kept it to myself didn't really talk about it.

Scott Benner 33:46
Did you eventually find people in real life that you could confide in. I

Speaker 2 33:51
never really got the experience until after getting to college. And then once I graduated college, it's all I see, you know, you can easily search Medtronic champions, you see people that pop up, and you're like, wow, look at all this content. And I think that's something that motivates me started embracing more, you know, how I'm able to type one diabetes, Medtronic,

Scott Benner 34:11
diabetes.com/juicebox, to hear more stories from the Medtronic champion community.

Scott Strumello 34:19
Mainly, yes, you know, I didn't look at every single, the FTC letter, you can actually read it and list all the patent numbers, but then you've got a Google patent number, blah, blah, blah. You know, you have to look up each one there's 36 of them. I looked up to just a spot check. And both of them are for pen injector devices. And my only conclusion was, ah, so this is their game. They're inappropriately listing pen injector devices used with the GOP ones to prevent or delay biosimilar competition from coming for two and a half years. And we don't even know if the biosimilars I mean, they're, they're now pending FDA approval, it's possible the FDA may come back and on one or two of them and say, you need to fix this before we approve it. And so you know, they'll get a complete response letter. I can just surmising here. But that's theoretically possible, of things that could happen.

Scott Benner 35:20
Also, I don't know anything, I just don't want stuff standing in the way of people getting what they need. And I don't want to see this whole insulin thing start over again, with a different medication that's going to be important to people with diabetes, you know, like, that's the stuff Listen, my brother has type two diabetes, his a one C went from in the mid sevens to the mid fives, he did nothing different. But shoot ozempic. Yeah. And he doesn't make a lot of money. You know what I mean? Like, his life is being changed. It's being lengthened, it's healthier. And two and a half years. Some people might hear that and go, it's just two and a half years. You go ahead and live within a one see a seven and a half for two and a half years and see if you don't think it's a long time. You know what I mean? So,

Scott Strumello 36:04
I tried coming up with the money, you know, to pay for these things. In the meantime,

Scott Benner 36:09
sure, just pay 28 $29,000 a year so that you don't die.

Scott Strumello 36:13
I mean, you know what, what happened with insulin, the pharmaceutical industry reached sort of a compromise. They said we'll sell a cheaper version of our product. We'll just sell it under the generic drug name. So you have Lilly human log in and Lilly insulin lispro injection, exact same assembly line. They're the exact same drug. It's just one is branded, one is unbranded, the cheaper an unbranded product. It seemed to be the way that the pharmaceutical industry could not piss off the PBMs and sell a cheaper version of their product. My guess is that when these biosimilar products for the GLP one, liraglutide come to market, we probably will see a dual branded unbranded strategy from from them. And by the way, some of the biosimilar companies also white label their products. That's basically private label, they sell it under the stores brand. So let's say you have a company like Lynette company, which is one of them that has liraglutide pending FDA approval. If Lynette company introduces a copy of sex ed up, they will sell one version, the brand at something, and they may sell another one under the Rite Aid, pharmacy brand name. I mean, that's entirely possible. And you wouldn't know it's it's made by Lynette because it carries the Rite Aid pharmacy brand instead. But I think the dual branded unbranded strategy seems to be something that the industry found was workable, invoking the ire of the PBMs. Because the BDMS they're sleazy companies, they, you know, they'll threaten, they'll say, We're gonna keep all your products off off formulary if you if you stop paying us kickbacks, you know, I mean, they do stuff like that. And there's really nobody policing it.

Scott Benner 38:13
I'm super interested to see if I get a cease and desist letter for putting up this episode, actually.

Scott Strumello 38:19
Well, you know, the question is, from whom?

Scott Benner 38:22
Yeah, oh, yeah. I can't even decide who it might be from to be honest with you. Listen, from my perspective, I'm just, I'm the father of a kid with a type with type one. I'm a person who's seeing GLP change their own life and other people's, and I can't I don't have the energy at the end of month, the last third of my life, Scott, I don't have the energy to watch this happen again. And like, Please, look back at the insulin thing, see how it ended up for you. And just don't make the same mistake again. You know, that's kind of how it seems to be. I have a couple of questions for you. I've crafted questions from three perspectives. So I have patient perspective, FTC and pharma perspective. Okay. I want to ask them like this. So let me start with the patient's How do you think the FTC challenge to the orange book listing will impact the affordability accessibility of GLP inhibitors for patients?

Scott Strumello 39:15
So number one, it opens the door to cheaper biosimilar products, admittedly, older products, but still efficacious, so they still work to come to market two and a half years sooner. So that's, that's the first thing. I also think you know, we could see, the essay said that branded and unbranded strategy, the branded is the heavily rebated to PBM. Market, and then the unbranded product will either be sold as the generic drug name or it'll be sold under the pharmacy name. So I do think we will see cheaper biosimilars coming to market and probably by the end of the year or early next year,

Scott Benner 39:57
okay. Can you think of ways that patients will benefit most from that availability. Well,

Scott Strumello 40:02
number one cost, right? Okay. You know, the biosimilar products are going to be a fraction of what the original or the branded products from Lilly and Novo Nordisk sell for. So cost is the big one. And then also, I think, you know, we're hearing stories. I don't know how many of the stories are hyperbolic of shortages of these products. And some of it is because internal production capacity to fill in finish these pen devices is constrained, Novo Nordisk already announced that they were going to stop making the patent expired Basal insulin levels here last year. So they could redeploy that manufacturing capacity to ozempic. And, you know, whatever we go V. Yeah, we go we Yeah, I can't keep them straight anymore.

Scott Benner 40:55
That's a lot. Yeah.

Scott Strumello 40:56
Yeah. You know, assuming they're all approved, and we don't, you know, those are unknowns right now. But what we know, a whole bunch are currently pending FDA approval. Okay.

Scott Benner 41:07
So from the FTC perspective, what do you think the regulatory intent was behind this? Because it's something that's happening, they notice it, but you still gotta get somebody off? They're asked to do something about it. Like, why did they act?

Scott Strumello 41:19
Some of it is just to police. You know, there are regulatory authorities that the FTC has, I should point out that since 2022, the Federal Trade Commission has been studying the pharmacy benefit manager business, their study is currently underway, they expanded it a year later, to include CBM own group purchasing organizations or to POS you know, they're investigating their, their rebate, aggregation processes. So I think the FTC study is going is likely going to uncover a lot of knows, you know, a lot of inappropriate and sometimes illegal behavior. And I think what we could see is either the FTC and or the US Department of Justice may alter when that study concludes. By the way, a couple of weeks ago, the FTC chair, Lena Khan, was at a White House open meeting about CPMs. And she noted that, even though the FTC had sent subpoenas to all of the insurance company owned P VMs, they had not fully complied with those legal subpoenas. So in other words, they're not giving them all the information that they've asked for. And that's a violation of law. So I think FTC is going to have to sue the PBMs. And say, we asked you for this, this, this and this, and you only gave us this, you will owe us a whole bunch of stuff. When that happens, I don't know. But it's holding up the outcome of their six piece study on the PBM. Industry. So we'll say, Well, I'd

Scott Benner 43:07
like to have you back on to talk about that sometime. So what do you think the FTC can do to ensure that, like, this doesn't happen? Like, can we put safeguards in place so that somebody just doesn't find a different loophole? You

Scott Strumello 43:18
know, it's hard to say, I think, because some of it falls under the purview of the Food and Drug Administration, the FDA, and the FDA has taken a very hands off regulatory stance on Orange Book, patent listings. But I think by the FTC stepping in and disputing a whole bunch of them, they're saying, we're noticing what Pharma is doing here. We think it's inappropriate. And we're taking actions which were are within the food, Federal Trade, you know, administration, or commission sorry, FTCS purview. And we're going to take actions to prevent that where we see it, you know, happening. FTC is understaffed, they probably need about 3000 more people to study Orange Book patent listings, if they were to do them all. But I think by by doing this, they have paved a path forward. So that if you're biosimilar company and you're looking to sell a less costly biosimilar, you may say, Well, wait a minute, this is automatically stayed for 30 months. And that's because of the FDA Orange Book. Let me look at all these patents. And so the biosimilar companies can also litigate for inappropriate patent listings. I don't know how good the machinery is to go through them step by step. But I would think if you're going to bring a biosimilar to market, that might be a path that could expedite your approval process.

Scott Benner 44:52
Before I ask the next question. I want to state for everyone listening that I am not nor have I ever been suicidal. So if I ended up suicided somewhere. I just want you all to know that ahead of time, Scott, do you feel suicidal at all? Not currently. Okay, good. So from the pharma perspective, how have you seen the pharma companies react to the FTC challenge?

Scott Strumello 45:13
You know, I think the the drug industry pretends like they didn't do anything wrong. They say, Oh, it was inadvertent, or it was a mistake or you know, sorry, are bad. But because there's really no punishment mechanism in place. They can keep doing it. But by the FTC opening the dispute process, I think you may see, you know, companies that want to make copies or biosimilars or generics, they may look to that and say, you know, we can litigate these things, too. Yeah. You know, the drug industry is basically saying, not our bad, sorry, you know, we have too many patents to worry about. It's a mistake inadvertent, we didn't do it intentionally. I think they did do it intentionally. But with the layers of complexity here. There's really not a lot of safeguards to prevent future similar kinds of abuses. But I think the FTC did open the door to potential disputes that maybe the FDA, because it's voluntarily populated by the pharmaceutical industry. Maybe they should take a closer look at these things. Yeah,

Scott Benner 46:27
listen, I'm a capitalist, and I understand looking for ways to make money and I get all that. And I do wonder if just shining a light on this isn't just going to, like, make darkness somewhere else. And you know, like, get it, they're just going to find another way to like, do the thing. And if that's not just the way things are done, and if you're not going to regulate it enough, and you don't have enough people to pay attention to it and follow it up, then is this all just inevitable? Or is it just a shell game? Right? Are we just moving things around pieces around the board? Or do you think it actually fixes something?

Scott Strumello 46:57
I think it's a good question. And to some extent, it is kind of like whack a mole, you hit one and another one pops up someplace else. On the other hand, I do think by taking these actions, and this that had never been done before, and some other government agency, the Federal Trade Commission stepped in and said to the FDA, you got all these patents listed. And they're not for the drugs, the medicines, they're for devices. We don't think these have a place in the orange book. And FDA said, You know what, you're right, are bad, we should have paid closer attention. We didn't. But thank you for bringing it to our attention. They are now removed from the orange book. Because it's never been done before. I think it opens the possibility that perhaps in the pharmaceutical industry, you may see something else to sue about in the future.

Scott Benner 47:53
And you're gonna Well, listen, it's also not lost on me that, that pharmaceutical companies are large organizations that pay people have a significant amount of money. There are a lot of smart people working in pharma companies, and they they get a big salary. And we're asking him to do these things. I'm using the GLP medication. I'm incredibly grateful for it. I'm you know, so is there a way for them to protect innovation, and allow them to make, you know, as much money as they can, like without like, like, you don't I mean, like, is there a way to do this where they benefit? And so do we, and nobody gets screwed? Like, you

Scott Strumello 48:30
know, I don't think Pharma is losing here, what they're losing is three, you know, two and a half years of extra noncompetition that they weren't entitled to in the first place, they already have patent protection on these products. And by the way, the patents on biologics is longer than it is on small molecule drugs. That was something that many people thought was inappropriate when it happened. Lo and behold, they got it, you know, an extra like five years for him. I think the patent system is in place, and it will protect farmers interest, their legitimate interests. They're not so legitimate interests. Nobody has to protect that stuff.

Scott Benner 49:13
Yeah, I would imagine they'd make the argument about the extra five years for the biosimilar stuff, that the biologic stuff that they just be like, Look, this is new science, we it might not bear fruit for a while it is probably going to help mankind in the long run, you got to you got to make it so that I can put the money into it to find out if this works or not. I would guess I mean, that's the argument I'd make if I was them. That's

Scott Strumello 49:34
what they said when you know when the decision was made to to pass that, you know, the patent on biologics as opposed to small molecule drugs. That's exactly the argument they made and they got what they wanted. Again, the patent system is giving them the, you know, that exclusivity and they're getting longer for it on the biosimilar and the biologic medicines than they are in the smaller guilds. rods here. I think they get the pharmaceutical industry has exactly what it wants and should have. I think what is happening right now is things are being taken away from them that they weren't entitled to in the first place. Okay. So

Scott Benner 50:16
you know, we didn't even say this when we started Scapa, you have type one diabetes, how long have you had it?

Scott Strumello 50:21
I will be eligible for a Jocelyn 50 year metal in 2026. Jesus, how old are you? I am 55. Wow,

Scott Benner 50:32
you were diagnosed in your five

Scott Strumello 50:35
sevens delayed? did this wrong? I'd let it done the math wrong. I have to do it on the calculator. Now I can't keep drawing. My

Scott Benner 50:43
daughter was two. She just turned two. She's 20. Now. Yeah, crazy, you know,

Scott Strumello 50:48
times zooms by and you don't even realize that it's gone already.

Scott Benner 50:52
Let me ask I have two more questions for you. So the first one is, why do you do this? If it's not your job? And you see this happening in the world? I saw what you said on LinkedIn. But I want you to tell people about it. Like, I feel like you were saying, Why is no one paying attention to this? Like, why am I not seeing this on the news? Why am I writing about this? I felt like is what you were asking. Yeah,

Scott Strumello 51:16
I do think that's exactly. And I opted to self publish it because I felt like it was a vital story that needed to be told, and nobody was telling it. And, you know, look, I I kind of, you know, complained to, you know, the media alerts. But I figured it's not worth my effort. I you know, I can I can write this in a short coherent format. And hopefully, people will go to the the article and read it because I think the story is worth telling. We can't really rely on corporate media to do this stuff. The media is, you know, they, they're sort of struggling with, how do we make money, you know, and do we do clicks? Or do we do you know, that the media outlets, financial advertising driven revenues have changed a lot over the last 10 years. And they have their own issues. They rely primarily on freelance art, you know, authors, not so many paid staff anymore.

Scott Benner 52:24
And not someone like you who's been picking through this for years. Yeah,

Scott Strumello 52:28
I mean, this was stuff I wrote literally in like, 45 minutes. It was not. Yeah, truth be told, I did write i, for me, the research part is the interesting part. So I wrote like a long ass article. And then what I ended up doing is turning to AI and said, cut this down so that it's more digestible. And so I happen to use Google Bard or Gemini, I guess, is what they rebranded. I entrusted the AI to edit it for me, I did that I then reread it made a few tweaks, and then it's two things I thought needed to be in there. And so that's kind of what I ended up with. But it started out with my work, you know, wasn't like generated by the computer, I did the research, you know, I just used it for an editorial function. I

Scott Benner 53:20
don't think that it's reasonable for us to expect everyday people to believe care, or look into the idea that a patent that doesn't belong on a plastic injector might stand in the way of them getting something for extra two and a half years, you know, like that. I don't know how we're supposed to all keep up with that stuff. You know what I mean? It's

Scott Strumello 53:40
crazy. And, you know, this is because it is such a complicated and highly regulated industry in the first place. The drug industry is is not for wimps, you know? But on the other hand, you know, it also it doesn't mean you can be, you know, a vulture capitalist and break the law. Yeah, you know, you might consider it a sleight of hand, but in fact, it impacts real world people. In this instance, the FTC stepping in, really helped open the door for it. But there could be other conditions that have similar issues. You just have to roll up your sleeves and do the research and figure out why it's happening and then find the root cause. I think one of the issues on insulin that we discovered was the, for a long time. What we were told was the reason prices are high was because the pharmaceutical industry prices them out. That wasn't really true. What was happening was the PBMs were, you know, doing stuff behind the scenes, they were acting in anti competitive fashion. And nobody was noticing it. They were doing it because they didn't have to tell anybody about it. Yeah. Now, I think you know, I spent many years kind of uncovering what how things have happened. And it was fascinating journey along the way. But the bottom line is, you know, this is stuff that I consider myself pretty knowledgeable about these days. And hopefully, you know, someday when there's some other drug that I need when I'm dying of cancer or something, I may be able to do something there. Yeah, that's

Scott Benner 55:20
my thought, as you're talking about, you know, like, when you said like, oh, somebody probably just thought they had some business sleight of hand great idea got themselves a little extra bonus, their boss liked them a little bit. And meanwhile, there are people out there not getting insulin. Yeah. And you know, and to say, Oh, don't worry, it's gonna come off patent in this much time. Well, there's a lot of people who get hurt between now and whenever that happens. And then it could be too late for those people at that point to you know, it just there's some things. Listen, I'm, I'm with you, like, people can't be vultures about it. But I'm alright, with people making money and innovating and running businesses. All that makes sense to me. But at some point, you do have to step back and look at the human impact of what's happening here and say, This has to be part of the equation to some degree, you know, you can't just let a lawyer make this decision. Like somebody's got to actually, you know, many times I've spoken to somebody who works at a pharma company or device manufacturer or something like that, they don't have diabetes, when you start talking to him about it, they don't even understand what it means. Like, they don't know what it's like to live with it. They don't even know what they're doing to you, or helping you with even sometimes, like even the good things they're doing. They don't have an appreciation for why it's valuable for you. Yeah. And, you know, so you can't put that decision on a bean counter when it's got real world implications at the

Scott Strumello 56:38
end. Yeah, I mean, I do think there, you know, like, on the insulin case, in particular, I think JDRF stepped in and kind of helped bankroll a nonprofit drug company to bring biosimilars of the three best selling insulins to market. Those are now pending FDA approval, by the way, they have insulin pens, when you

Scott Benner 56:59
say JDRF do you mean breakthrough tea one day breakthrough tea,

Scott Strumello 57:03
Wendy, as of yesterday? Yes. It'll take me a while to get used to that. But yeah, but you know, there, again, nonprofit sector really played a role in enabling that to happen, you know, on the obesity issue. I don't know who their advocacy organization is, but presumably there is one? And if not, maybe somebody wants to start one.

Scott Benner 57:26
Yeah, they should. Let me let me ask you to I guess I said two more what I meant three more. Let me say this to you. It's not a question. If you sit down and put together a thoughtful list of PBM style interviews, I'll do as many of them with you as you want. If you'd like to lay out what they really explain to people what they are and how they work and where it hurts them. I would be fascinated by that. It's no pressure. But but that would be amazing. And then my last question is, do you have any idea about this new Mark Cuban led, online pharmacy, and what impacts that might have for people with diabetes? And

Scott Strumello 58:01
the PBM thing? I'll I'll shelve that. For now. I think there's there if you could even get them to talk to you, which is highly unlikely. There would be a boatload of questions. But I'm not confident that whatever happened,

Scott Benner 58:15
I have a series called cold wind where we take out people's names and change their voices. So if anybody has recently retired, incredibly wealthy from a PBM, and once the unburden their soul, please give me a call. Well,

Scott Strumello 58:26
here, here's something you could turn to, and that is that the civica nonprofit drug company civica script is its consumer facing you. And the CEO of the civica script operating unit happens to be a former optim r x executive. And she did a whole interesting podcast on you know, like, how her PBM experience really helped her in the role. And so I would defer on that one. What was the you mentioned something else? Mark Cuban? I

Scott Benner 58:57
think once you What do you see impact for people with type one from Cubans new pharmacy? Yes,

Scott Strumello 59:05
I do. I think whether anyone cares to admit it or not, Mark Cuban's cost plus pharmacy has had a very big impact and will continue to have a growing impact. And there's a lot of reasons for it. But introducing transparency is kind of a key that he's doing. And Alex Ashby outski, who's the founder and president of hospice drugs, who works for Mark Cuban, he has type one himself, so he he knows this stuff inside now, but I do think we will see cos FOSS drug company, for example, may be selling a GLP one inhibitor, one of the many that are now pending FDA approval. I would not be surprised to see one or more of those coming from them. They're gonna give you an honest So, you know, 15% markup, the prices are probably going to be better than you're gonna get from your PBM. From your insurance companies. So look to them, I think they, it's definitely on their radar, and it's coming. Great. And by the way, one other thing that I think cost plus drugs is doing that's kind of interesting that is a little under the radar is the team cubing card initiative that they've launched, which is basically they have a network of local pharmacies around the country that will sell their drugs at cost plus drug prices. But you can just go into a local pharmacy and do it. That's kind of a cool thing. Because for things that need to be temperature controlled, like insulin and GLP ones, you might not want to do it mail order, but you might be willing to walk into a local pharmacy and buy it.

Scott Benner 1:00:52
Okay, that's interesting. This is usually the point where I say, is there anything I didn't think, to ask you that I should have?

Scott Strumello 1:00:59
No, just what I would ask is just share the link to my article. When you post this, I think others might like to get to read it. And I think it's an interesting article to say,

Scott Benner 1:01:10
I agree. And Scott, I'd be happy to share the link to it. I'd be happy to repost it if you want me to you just let me know what you'd like. Yeah,

Scott Strumello 1:01:16
I mean, when you post this the show, just include the article link with it. I think that's, that's relevant.

Scott Benner 1:01:24
I'd also like to put your blog up there, because I think people should see some of the other things you've been thinking about and talking about as well. You can welcome to do it. Let me ask you this last little bit at the end. How did the South Park GLP episode strike you?

Scott Strumello 1:01:40
Well, truth be told, I'm not a paramount plus subscribers. So I watched the I watched a summary of it. And I watched the trailer for the episode that struck me is sort of very indicative of off label marketing. And I'll leave it at that. That stuff that farm is not supposed to do, but somebody thought it was an interesting idea. And they did it. You know, interestingly, they talked about semaglutide semaglutide semaglutide. They mentioned that their drug name, like over and over and over in that episode, so it was

Scott Benner 1:02:14
interesting, there's something sinister with the South Park episode. You believe that it's a marketing tool.

Scott Strumello 1:02:19
I believe they're they're making they're depicting the drugs as not legitimate medicines, but as mainly these drugs. You know, they

Scott Benner 1:02:30
never really spoke I watched it didn't really speak about diabetes at all. No, yeah. Yeah. And it listen, it was the first third of it was oddly accurate. And like, you know, and funny, but like it was, but it was obviously overblown in cartoon eyes, which is, but I would expect, right at the end, when you know, machine gun wielding moms are double fist injecting, you know, GLP and then attacking trucks with DLP medication inside of it, trying to find their their stash. I mean, it got into very ridiculous at the end. It was interesting. It never occurred to me that I never looked to see who who funded it. So I you

Scott Strumello 1:03:08
know, I don't necessarily think I don't think you can point a straight line to Novo Nordisk and say that, and truth be told, there was a clip in there were, they said, both, like ozempic and Manjaro, which are two competing products from two different companies. That didn't hold that closely to it, but, but I do, it did strike me as sort of, kind of weird off label marketing for these products. I will tell you this intentional or not, even satirically,

Scott Benner 1:03:41
it was pretty on point. So

Scott Strumello 1:03:45
you know, the thing I found most funny about it was when they go into the dark room behind where the actual insurance like person worked, and it's like this dark closet with an old typewriter and a fax machine guys

Scott Benner 1:03:57
going very slowly, and then he picks up the phone and he says, he doesn't say anything. You don't hear anything on the phone. He hangs it up. He goes, medical director said no. I was like, yeah, yeah, at some point, he actually said the line like something about like, we always say no, so that then you have to go out there and battle the healthcare system. It was interesting, because it's, it was very satirically. correct on that part of living with like, you know, an illness where you're constantly fighting and arguing with people and, and running in circles feels like you're on a hamster wheel to come back to here. Now again, to just try to find another perspective to one day someone just goes okay,

Scott Strumello 1:04:36
the thing is, the thing I find funniest about it was because there was probably more truth to it than fiction.

Scott Benner 1:04:44
I thought, alright. Anyway, I would say I'd lend you my Paramount plus login, but I don't want to get in trouble. Scott, thank you very much. I appreciate your time. Can you hold on for one second for me?

Scott Strumello 1:04:54
Sure. Thanks.

Scott Benner 1:05:00
A huge thank you to one of today's sponsors. G voc glucagon. Find out more about Chivo Capo pen at G Vogue glucagon.com forward slash juicebox you spell that GVOKEGL You see ag o n.com. Forward slash juicebox. A huge thanks to us med for sponsoring this episode of The Juicebox Podcast. Don't forget us med.com/juice box this is where we get our diabetes supplies from you can as well use the link or call 887211514 Use the link or call the number get your free benefits check so that you can start getting your diabetes supplies the way we do from us med. Jaylen is an incredible example of what so many experience living with diabetes, you show up for yourself and others every day, never letting diabetes to find you. And that is what the Medtronic champion community is all about. Each of us is strong and together we're even stronger. To hear more stories from the Medtronic champion community or to share your own story visit Medtronic diabetes.com/juice box and look out online for the hashtag Medtronic champion. To read Scott's blog, go to blog dot s s t r u m e l l o.com blog.ss t r u m e ll o.com. I know that Facebook has a bad reputation. But please give the private Facebook group for the Juicebox Podcast. A healthy once over Juicebox Podcast type one diabetes. The group now has 47,000 members in it, it gets 150 new members a day. It is completely free. And at the very least you can watch other people talk about diabetes. And everybody is welcome type one type two gestational loved ones, everyone is welcome. Go up into the feature tab of the private Facebook group. And there you'll see lists upon lists of all of the management series that are available to you for free in the Juicebox Podcast, becoming a member of that group. I really think it will help you it will at least give you community you'll be able to kind of lurk around see what people are talking about. Pick up some tips and tricks. Maybe you can ask a question or offer some help Juicebox Podcast type one diabetes on Facebook once there was a time when I just told people if you want a low and stable a one C just listen to the Juicebox Podcast. But as the years went on, and the podcast episodes grew, it became more and more difficult for people to listen to everyone. So I made the diabetes Pro Tip series. This series is with me and Jenny Smith. Jenny is a Certified diabetes Care and Education Specialist. She's also a registered and licensed dietitian and a type one herself for over 30 years and I of course am the father of a child who was diagnosed at age two in 2006. The Pro Tip series begins at episode 210 with an episode called newly diagnosed or starting over and from there all about MDI Pre-Bolus thing insulin pumping, pumping and nudging variables exercise illness, injury surgeries glucagon long term health bumping and nudging how to explain type one to your family. Postpartum honeymoon transitioning all about insulin Temp Basal. These are all different episodes, setting your Basal insulin, fat and protein pregnancy, the glycemic index and load and so much more like female hormones and weight loss. Head now to juicebox podcast.com. Go up in the menu at the top and click on diabetes pro tip. Or if you're in the private Facebook group, there's a list of these episodes right in the feature tab. Find out how I helped keep my daughter's a one C between five two and six two for the last 10 years without diet restrictions juicebox podcast.com Start listening today. It's absolutely free. If you're not already subscribed or following in your favorite audio app, please take the time now to do that. It really helps the show and get those automatic downloads set up so you never miss an episode. Thank you so much for listening. I'll be back very soon with another episode of The Juicebox Podcast. The episode you just heard was professionally edited by wrong way recording. Wrong way recording.com