This episode contains audio from Fixing a Broken System: The Path to Public Pharma in New York. It was recorded on September 25th, 2025.
Public pharma is an alternative to our current profit-driven pharmaceutical system. Public pharma uses the public sector to research, develop, manufacture, and distribute drugs.
“Fixing a Broken System: The Path to Public Pharma in New York” is a critical discussion that will illuminate the transformative potential of publicly owned, manufactured, and distributed pharmaceuticals as we confront an industry that has prioritized profits over patients for too long, leaving patients without access to the medications they need to survive.
The discussion was organized by T1International, the NY #insulin4all Chapter, NYU Law’s Science, Health, and Information Clinic, and The Health and Political Economy Project of the New School's Institute on Race, Power, and Political Economy, and hosted by the Engelberg Center on Innovation Law & Policy. Speakers included New York State Assemblymember Jenifer Rajkumar, former New York City Health Commissioner Dave Chokshi, and Yale School of Medicine Professor Kasia Lipska.
More information: https://www.nyuengelberg.org/events/fixing-a-broken-system-the-path-to-public-pharma-in-new-york/
Announcer 0:00
Welcome to Engelberg Center Live!, a collection of audio from events held by the Engelberg Center on Innovation Law and Policy at NYU Law. This episode contains audio from fixing a broken system the path to public pharma in New York. It was recorded on September 25 2025
Christopher Morten 0:20
My name is Chris Morton. I am your MC this evening. I'm an associate professor of law here at NYU Law. I'm also an affiliate of the engelberg center on innovation, law and policy, and director of the Science, Health and Information clinic here at NYU Law. Through the clinic, I represent pro bono, t1 International, an independent diabetes patient group. We have representatives of t1 international here tonight, as well as the New York insulin for all chapter, I'm going to introduce them in just a moment, but I'll say t1 international and its patient advocates are leading analysis and advocacy of a public option in pharmaceuticals, not just in New York but around the country. On your seat should be a flyer with QR codes you can learn you can use to learn more about tiju International and the New York insulin for all chapter, I want to first acknowledge and thank our institutional host and sponsor, the NYU engleberg center on innovation, law and policy. It provides an interdisciplinary environment where scholars examine the key drivers of innovation, as well as the law and policy that best support innovation. Huge, huge. Thanks to Michael Weinberg. I can't see him, but I think he's here somewhere. Michael Weinberg, Executive Director of the engelberg Center. Thank you, Michael. And huge thanks also to others at the engelberg center for this space and for so much more making this event happen. And what are you guys coming in Hall
Speaker 1 1:53
for the t1 i event on the Zoom, oh, I'm actually here to redirect people, because we know it's very strange. Is it coming through the zoom? No, it's yeah, it's just okay.
Christopher Morten 2:13
Thank you. Thank you. I was just gonna say also, well, let me say, Okay, I'll get to Claire in just a second. But thank you, Claire for running the zoom. I want to say Special Thanks. Speaking of the engelberg center to Al engleberg, a distinguished alumnus of NYU Law and a leading pharmaceutical lawyer who endowed the engleberg Center, but also generously provided us with funding for tonight's event. Okay, also huge thanks to Claire Huang and Eve zellickson, who are students in the NYU Science, Health and Information clinic and represent t1 international with me. They will not be speaking tonight, but they have worked enormously behind the scenes to pull this event off, Also, thanks to the health and political economy project, hpep at the new school's Institute on race, power and political economy, who helped conceive and organize tonight's event. We have, I think H peps Mara, Hennigan and Victor Roy in the audience. Shout out to you guys, thank you for being here. Okay, and now let me introduce some of the distinguished speakers you'll hear from so from your left to your right, we have first Shana Casper, Executive Director of Tijuana International. Applause is appropriate if you guys want emerald Anastasia, a patient advocate with the New York insulin for all chapter. Emerald is a writer and artist, originally from Bakersfield, California, now lives in Brooklyn. You're going to hear more about these folks and their work and their their stories as they speak, but I want to give you a little context at the outset, next we have Dr Kasha lipska, Associate Professor of Medicine at Yale School of Medicine, and a noted endocrinologist and clinical investigator. And then next we have Sarah lAmore, a third year law student at NYU Law, and most important, just kidding, a student attorney in the Science, Health and Information clinic, Humphrey, excuse me, yeah. Humphrey Shen, to Sarah's left, is also a third year law student at NYU Law, also a student attorney in the Science, Health and Information clinic, like me. Sarah and Humphrey represent tun international pro bono. Next we have Max Goldberg, leader of the New York insulin for all chapter, and all these folks will get to say more about themselves in their remarks. I also want to introduce Allison Hart, who will be chiming in in Q and A. And I'm gonna say a little bit more about Allison, because she won't have the same prepared remark opportunity. She is Tijuana International's development manager since 2020 Allison has supported Tina international advocates and partners in advancing public pharma policy in the United States, including efforts for states to manufacture and bulk purchase insulin for their citizens. She serves on the calarex patient advisory council, and her partner, Matthew, has been. Living with type one diabetes for 40 years. Thank you, Austin for being here and for all the work you do. Okay, we are also joined by a couple more folks from t1 i lib Gotti and Kate pirbecky. Lib, and Kate will be helping me MC and managing Q and A lib is t1 eyes USA advocacy manager and supports the insulin for all chapters all around the United States to run campaigns that improve access and affordability of insulin and medical supplies. And they have been living with diabetes since 2018 I believe. Thank you Liv for being here, and Kate has served as t1 is operation manager since 2020 supports t1 is day to day, through bookkeeping, HR, comms, operations and more, she has been living with diabetes since 2001 she lives in the Pacific Northwest, as did Alice, as was Allison. We're really grateful to some folks who've traveled very far to be here with us tonight. Last couple intros I will do. You're going to see on screen some remarks from Dr Jay. Excuse me. Dr Dave choksey. Dave sends his regards and his regrets. He wanted to be here, but had to send remarks by video instead. Dave is co chair of the Health and political economy Project H pap at the new school. He's professor at CUNY, but I think he's probably known to many of us as the former health commissioner of New York City during some of the darkest days of the covid pandemic, when he led the city's response to the to to the pandemic. And then, last, but very much not least, we're honored tonight to be joined by Assembly Member Jennifer Rajkumar, who represents the 38th District. Thank you so much assembly woman for being here. She represents much of Queens, Glendale, Ozone Park, Richmond, Hill Ridgewood and Woodhaven. She's a civil rights lawyer, a member of the assembly health committee, and I think really critically for this discussion, She's the lead sponsor in the New York State Assembly of the affordable drug manufacturing Act, which you'll hear more about in our discussion. Thank you so much, Assemblywoman for being here, and thank you all All right, really quick preview of the program so you know what to expect. Oh, I also forgot to say the event is being recorded on audio, and we plan to upload the audio as a podcast to the engelberg Center webpage after this, okay, let me give you a quick roadmap of what you're going to hear about tonight. The name of the event is fixing a broken system, the path to public Pharma. Shana emerald, Dave Chokshi, will set the stage by describing the broken system of medicines that we have in the United States. We'll then pivot to solutions. We'll hear from kasha, Sarah and Humphrey. They're going to introduce the concept of public Pharma. In a nutshell, what we mean by that is nonprofit, democratically accountable public agencies taking over some of the functions that are currently performed by or that we currently rely on from drug companies, pharmacies, pharmacy benefit managers, insurance companies, other for profit actors. Max is then going to tell us about an exciting development brewing right here in New York, the bill entitled The New York affordable drug manufacturing act. That bill would create a state owned nonprofit drug brand to manufacture and distribute insulin and other prescription drugs at low prices. And then finally, we'll turn the floor over to Assembly Member Rajkumar for her remarks, and we're going to try to save a little bit of time for Q and A. You should have found a little index card and a tiny golf pencil. So that is how we'll take your questions. We'll take as many as we can. Lib and Kate, maybe raise your hands again. Lib and Kate are going to be the facilitators of Q and A, and they'll be walking around gathering questions, but feel free to jot them down as the program gets underway. I hope that you will leave this room tonight informed and inspired. Our broken system is rooted in law and policy. It is not, excuse me, it is not an inevitable law of nature. Patient advocates, including the folks you see on stage and many others from the New York insulin for all child insulin for all chapter and t1 I not only experience every day what's broken in our current system, but have been imagining and analyzing, articulating, advocating and building a better kind of system, a better kind of world. The system we have is not only obviously to me, at least unjust, but also horribly inefficient. We pay more and more to the manufacturers and the middlemen of medicines for less and less innovation and for shortages, for cruelty. So what I hope you might take away from tonight is an understanding of public pharma as an alternative vision, a vision that imagines medicines as a human right, as part of healthcare as a human right, we can replace an inefficient web of profit seeking companies with democratically accountable public agencies that serve not just the patients with chronic illness, those most burdened with high drug costs, but serves all of us, all of us who pay taxes, all of us who pay insurance premiums, all of us who sign. For under the current system, at this moment of chaos and crisis in the United States and around the world, at this moment of chaos and crisis in the federal government, the work you'll hear about today, I hope, offers a ray of hope. There are things that we can do at the state level, even as the federal government fails us public pharma, for me, is a ray of light in the dark and affirmative vision of change during this dark and reactionary time. So actions at the state and municipal level, new laws, new ideas, are not only possible, but I think they're really urgently necessary, and I'm so grateful to get to listen to you. I'll talk about them tonight with that I will pass the floor, pass the mic to Shana Casper, can
Shaina Kasper 10:39
you answer me? Yes, great. Thank you so much, Chris. Huge shout out to all the students who work with Chris. It's incredible. So yeah, my name is Shana Casper. I'm the executive director of Tijuana International, and we're an organization of people with diabetes, for people with diabetes, working on insulin access and affordability. And I'm here because I live with type one diabetes. And let me tell you, I mean, I think there's lots of other folks here who can tell you, it's really hard. Living with diabetes is really challenging, and we really think that accessing your medicines should be simple, and it's not. We're going to talk a lot more about that. It is really outrageous how last year, with this being my job and with gold tier marketplace insurance, I still spent over $5,000 just to get access to the medicines that I need to survive. It's it's an abomination. We're getting ripped off. And so that's I'm going to kind of set the stage about why we need public pharma to improve access and affordability. There you go. So this is the original patent for insulin. So insulin was discovered over 100 years ago, and it was the patent for it was sold for in 1923 for $1 each. And they did this not to, not to just sell the patent for $1 but to make sure that this incredible discovery was made available and accessible to everyone, they patented it so that it couldn't be patented for profit. That was their intention, right? That was their dream, guys, because we're all here because we know that that is not true, and that didn't happen pretty quickly, so only 20 years later. This is a slide. This is a clipping from 1941 so not that much longer, right? Less than 20 years where they're indicted for price fixing. So this is not a new problem. You know? This is actually from the beginning. This, this is, you know, insulin price fixing has been a real problem, and it is ongoing. So prices just keep going up. Probably folks who are here today have seen this chart before. So in 1996 rapid acting insulin like this one here, Nova log was first came onto the market, and it was first introduced for $21 a vial. This chart goes to 2023 when it was over $250 a vial. And just to be clear, this is exactly the same product, right? This is exactly the same insulin in the same vial. There is nothing new that has changed about this product while that price has been going up, up up and the price has been going up in lockstep, this is in large part because there's only three companies that really control the majority of the insulin supply chain, Eli Lilly, Novo Nordisk and Sanofi. We're going to be talking about them as the Big Three today, right? And so they, they, because they, they, it was only three that dominate such a huge part of the market they really can have this, this monopoly that can really cause some serious problems. Um, they're so used to raising prices together that this is a some emails that were pulled from discovery, from 2015 where Eli lisity, the Eli Lilly, the makers of trulicity, said that they all they wanted for Christmas was for another company, Sanofi, to raise their prices too, right? Like they they were raising their prices in tandem so frequently that they knew that the other company would be raising them the day after they raised their prices. Okay, but I won't make you raise your hand. But have folks been seeing some headlines saying the insulin price crisis is solved? Everyone can get Okay? Can raise thanks. Yeah. I've been seeing these headlines too. Everyone should have access to $35 insulin right. Biden passed some legislation, the inflation Reduction Act, but we really wish that were true. But we're here today because, because it's still not $35 for a month of in. Insulin is still making these pharmaceutical corporations a significant profit. This data here shows that the actual cost of manufacture for a basal bolus regimen like the kind of the rapid acting insulin and the long acting insulin only, it costs less than $10 a month to manufacture that insulin. But in New York, people are paying almost $75 a month on average, based on our most recent survey across the US, it's double that, $152 a month. This is how much patients living with type one diabetes are paying every month just to stay alive on average, right? So some people are probably spending a lot more, and this is also just for the cost of insulin. Living with diabetes requires having testing strips, continuous glucose monitors, glucose probably see some of us chugging some juice up here while we're at it too, like there's a lot of other costs that come with managing diabetes, so the cost of insulin is still much higher than the Promised $35 so what does this mean? This means that people are going without their insulin. 37% of people, based on our most recent survey, are rationing their insulin due to cost. So that means that they are reducing doses, skipping meals, not filling their prescription, or delaying picking up their prescription. And so for people like with type one diabetes, like myself, insulin is like oxygen, like we need it to survive. We can't go very long without it. And for many people with type two or other types of diabetes, it's really important to control complications. So rationing is really serious and can cause really serious health impacts and even death. Now we've been doing this survey of looking at costs and rationing for a couple of years now, and what we've been seeing so the survey is not the same population of people, but we're asking basically the same questions. And what we found is that the number of people rationing insulin has doubled since we started taking this so about 18% in 2018 I can't see that far, to 37% in 2024 so the problem is getting worse. Like, I guess, you know, even if some companies are lowering some of their prices, the number of people rationing their insulin has doubled since the insulin price crisis is supposedly over. And, yeah, as we've said, you know that that is really, really significant. Okay, I just turned up this slide, and I feel like I like, heard some of the oxygen get taken out of the room. So apologies. It's a little scary. And I'll just say I think the system is designed to be really opaque and to set to, like, make us feel scared by looking at the system and to not try to engage with the system, right? So let's look at it together, and let's just dive in for a few minutes here, because we'll be talking about each of the pieces as we go along. So insulin manufacturers, Eli Lilly, novo, Nordisk Sanofi, they make the insulin, they then sell some of their their formulary placements by using these pharmacy benefit managers or PBMs, so they get their insulin onto they sell these rebates to get their insulin onto the drug list, onto the formularies that they then work to get them onto the health plans, onto your insurance companies, right? And so then when I go to the pharmacy counter and I pay my co pay for my insulin, that those funds combined with my insurance premium funds then go to the pharmacy, and they go to the wholesaler and back to the manufacturer, as well, as you know, from the funds from the insurance company. Okay, but what does this like? Actually mean, who is harmed in this? So, you know, first of all, people without insurance, when they go to the pharmacy counter, they can't there's no rebates available for them. They have to pay that full price, right? Really, really expensive, really harmful, for people without insurance or for people with high deductible plans, who have to pay all the way up to you get to that that deductible, who this also harms is people like me with really good insurance, but I am forced to navigate this complicated system. I'm not from New York. I'm here on this trip. If I need to go to the pharmacy to get insulin, I'm going to have to call up my prescriber to get my prescription moved, but also navigate the pharmacy benefit manager, navigate with my insurance or be forced to pay that full out of pocket costs. And remember, the clock is ticking. Insulin is like oxygen. We only have about four hours for myself before I have to go to the hospital without insulin. But also, who this harms is everybody on insurance. As Chris mentioned, insurance premiums in New York have been going up fast. Faster than the rate of inflation every year, and
Shaina Kasper 20:05
so, so, so costs are a big problem. Costs are causing rationing. Also, what's happening is that there are a lot of shortages of insulin, right? And same thing is all the same problems with rationing. We all need this insulin, but that sometimes we can't get it. So we did this study a couple of years ago with Senator Blumenthal and Warnock and Wow, sorry, Senator Warren. I That's embarrassing, but so we found that in 83% of the pharmacies where we called them up and said, Do you have this generic insulin list Pro on the shelves, they just didn't have it. It wasn't available on the pharmacy shelves. That's been one of the cheaper insulin, short acting insulin options. We also, in our survey that was talking about earlier, we found that almost 70% of people had had experienced some some sort of shortage. So, you know, so So of not being able to access or be able to find their insulin because they had to go to a really far away pharmacy. It wasn't on their pharmacy shelves at their local pharmacy, or for some other reasons. So we're experiencing a lot of shortages. Why are we seeing some of these shortages? I myself was on insulin levamire. I had prescription for levamire Novo Nordisk, one of those four companies was also one of the companies making ozempic and wegovy, these big, big name GLP one drugs that are very profitable, and they use a lot of the same manufacturing capacity. They come in the same types of pens. There's still a biologic drug, and they're making a lot more money off of these drugs, and so some manufacturers have decided, like Novo Nordisk with levamire, have decided to stop making these less profitable drugs, to be able to move that manufacturing capacity over to other drugs. So that leaves patients like me who use this insulin for years and been used to this insulin, forced to shift over to to a different to a different drug. So in conclusion, a vial of insulin costs less than $6 to manufacture, but it's sold for over $300 the pharmaceutical industry inflates the price. PBMs play this middleman, and people with diabetes pay the price. The market is not broken by accident. It is made this way to benefit corporations while patients go without and that's really why we need public Pharma. That's one of the big reasons why we're here today. We need a structure that actually puts people over profits. So Thanks much.
Christopher Morten 22:41
Thank you so much, Shaina. And next we have emerald Anastasia. Hello.
Emerald Anastasia 22:45
Can you all hear me? Whoa. All right. My name is Emerald rose Anastasia, and I was diagnosed with type one diabetes at the age of 18, and she was my sweetie heart, because it was on Valentine's Day, and I found out about it, because after gaining wings, drinking a Red Bull, I collapsed, and that was one of the few times patriarchy tried to kill me. So type one diabetes has impacted my entire life, and it feels distant and fuzzy to think of a time when my brain was not also a pancreas, when I did not have to think about an insulin dosage before eating a meal, or getting hyperglycemic for hours after a late night binge eating pizza, or if I lost my diabetic supplies while traveling, it would put me in a very dangerous situation. I joined two one international because I have had times when I went to the pharmacy and didn't have insurance coverage, and the cost of my medications were astronomical. For example, recently, I tried to do an online order for insulin, and the online pharmacy claimed I had to pay $2,000 for a month's worth of rapid acting insulin. I recognize in our present reality, pharmaceutical companies are acting with impunity, price gouging essential medications chronically ill people need to survive, and prioritizing profit over human lives was untenable, and I want to join the insulin for all movement to galvanize change in the United States. 37% of type one diabetics had to ration their insulin in 2024 although insulin rationing is the most egregious impact of pharma greed, there's also a degradation in the standard of care people receive based on their insurance access and how much money they have. I know this from personal experience, although I know that insulin pumps and continuous glucose monitors are the best standard of care for the first 10 years of my diagnosis, I didn't use either of them. There is an intense gatekeeping for the top standard of care for diabetes, and knowing that my access to health insurance is very precarious has forced me to stay on a treatment regime that has worse health outcomes. This is in part because my access to insurance is unpredictable, because I have this chronic illness that has been made completely unaffordable by the greed of the pharmaceutical industry. Having quality health insurance is of the utmost importance, but many jobs don't have health insurance or good health insurance, and so I've been relying on my father to keep me on his works insurance. Now we're in this bind where my father is continuing to work, although he has been ready to retire for some years now, if my father stops working or loses his health insurance, I would lose access to health insurance, which would make the reality of insulin rationing, downward economic mobility and the possibility of death an excellent, an excellent, excellently, except exponentially higher percentage and as non ideal situation for either of us, and yet, given the acute cost of my medicines without insurance, it is what we are forced to do right now. Out of honesty, I often feel defective due to my circumstances and fate in my life, being unemployed, living with depression, anxiety, being autistic and fats, due to the values of us, American society and life experiences which can make me perceive that I am inferior and less than However, at the same time, I can experience sanguine glimmers of hope when I remember I'm not alone in these experiences and that these insecurities are a reflection of an unscrupulous medical industrial regime we're being held hostage to public production of insulin, sorry, public production of insulin by an entity like New York State would hold pharmaceutical companies accountable, like Eli Lilly, Novo Nordisk and Sanofi companies Who think access to quality and accessible health care should always remain a privilege, not a fundamental human right. Public Pharma is not solely a theory. It will save lives and help mollify the rapacious system of pharmaceutical corporate greed, which has led to patients dying 100% preventable deaths. The list price would be feasible for someone on a middle or low income and being able to afford insulin, and diabetics being able to live their best possible lives would be a collective rejoicing. I want to be independent and taking care of my health. And my dad deserves to retire after a decades long career being a family medicine doctor. He deserves to rest and enjoy his final years in retirement. And I and every other diabetic are entitled to essential medicines and high quality healthcare that would let us live life to the fullest. Thank you.
Christopher Morten 27:28
Thank you so much emerald. Next, we have some recorded remarks from Dr Dave Chokshi, and I wonder if someone had the clicker, if you hit Next on the or I can do it, just hit next and perhaps Dave will play let's see.
Dave Chokshi 27:49
Good evening. It's my privilege to be part of this exciting event. I just wish I were there in person first. Thank you to the engelberg center on innovation, law and policy, and the science Health and Information clinic at NYU Law, as well as t1 international and its New York insulin for all chapter for convening this important conversation. I'm Dave choksey, co chair of the Health and political economy project. I'm also a doctor at Bellevue Hospital, and previously I served as New York City's health commissioner. Through each of these roles, I've gained a different perspective on the perils of our current system and the promise of public pharma strategies toward a better tomorrow. At Bellevue, the nation's oldest public hospital, I see both the perils and the promise. Every week, I remember one patient who arrived in diabetic crisis, his mouth parched, breath tinged with the sweet smell of ketones because he had to ration his insulin. The painful irony was that his ICU stay with all its cost and suffering was entirely preventable with affordable insulin, a medicine discovered a century ago, another patient walked in with a new HIV diagnosis. Within hours, he was started on treatment thanks to publicly funded access that made antiretrovirals available the same day, weeks later, his viral load was undetectable, proof of what's possible when medicines are treated as common goods rather than commodities. Serving as the city's health commissioner through much of covid 19, I saw the promise of public approaches on a much larger scale, while much of the pandemic is painful to reflect on, we should heed the lesson it taught us about the necessary role of government in ensuring access to medicines and care. More broadly, the pandemic proved that the public sector. Can act effectively when given the authority and resources to do so, and that this action is essential to saving lives, we simply wouldn't have been able to vaccinate over 6 million New Yorkers in a little over a year without public research, public investment, public delivery, and yes, public leadership, we were also able to procure rapid tests and PPE and deliver them to places that needed them most urgently, like hospitals, shelters and schools. The knowledge gained during that crisis should push us to consider what it might look like for government to respond to the more everyday challenges of affordability that patients like mine face. Finally, as co chair of the Health and political economy project, I'm excited to be working with the hpep team and partners across the country to try to reimagine our pharmaceutical system. We see public pharma strategies from manufacturing initiatives like Cal RX to procurement initiatives like array RX as innovative potential steps on the path toward a more accessible and resilient Health System public pharma can protect providers and patients from supply shortages and soaring prices and augment the government's ability to both regularly serve residents and swiftly respond to crises. We're thrilled to be part of tonight's conversation, and I look forward to continuing to work in partnership with so many of you to build a more just health system. Thanks for letting me be a small part of tonight's dialog.
Christopher Morten 31:58
Thank you. Dave in absentia,
Christopher Morten 32:02
next we have Kasha lipska and Kasha I'm going to pass the clicker.
Kasia Lipska 32:08
Thank you so much. Thanks for having me. Can you hear me?
Speaker 2 32:14
Can you hear me? Have to be close.
Emerald Anastasia 32:18
Um, so I am a doctor and a health services researcher, and my job is to take care of people with diabetes like you, and I'm here because it's become impossible for me to do that, and it's heartbreaking. I did not think that I would be doing access to medicines and showing up at NYU Law school when I was training, and some of the regulatory stuff is so complicated that I was very grateful to Shaina to cover that. But I'm here because this is such an important issue for people with diabetes, so I didn't actually recognize the problem, because, as Shaina already explained, insulin is quite old. It was discovered over 100 years ago, and I really did not think that insulin prices were an issue. And you already heard about the patent, so I'm not going to go through that. But as we've heard from from Shaina and others, insulin prices have gone up dramatically, from just $21.96 for the same vial to over $256 much later, and these prices are still high. No wonder patients in my clinic are having issues with this. So I'm also a health services researcher. And in 2017 we conducted our own survey in our Diabetes Center to understand how often people are rationing insulin. We found at that time and 2017 that one in four patients were rationing insulin specifically because of its cost. And you can see that we surveyed anyone who was coming into clinic had a pretty good response rate, and most people had type two diabetes and were using insulin in our clinic. So it's a slightly different population. There was also a later study that was done nationally through the National Health Interview Survey that included people across the United States with diabetes who were prescribed insulin. And in that survey, the rate of rationing was a little bit lower. It was 16% but still 1.3 million people who require insulin in our country were rationing insulin in 2021 so have things gotten better? And as Shaina already alluded to this, we also found that things have not gotten better. We just completed this past summer another survey that was identical to the one we did in 20. 17 asking people if they ration specifically because of cost, and the rate of rationing was still one in four. Again, slightly different population than yours, type one and type two people with type one and type two diabetes. On this one, though, we also asked people if they rationed insulin for other reasons besides cost, because it's become clear that cost is just one barrier, and we found that rationing because of shortages or insurance delays were also really common. And if you took all of those together, 75 out of our 200 participants, roughly, who answered the survey or Well, well, more than a third reported they ration insulin due to any of these barriers. So didn't take, took less or skipped doses. So as a clinician, I will tell you, and as people with diabetes experience rationing has predictable, predictable consequences. So the reason why people with diabetes need insulin is that they don't have any. And so when blood sugars rise, that can lead acutely to poor control of the clue of the blood sugars can lead to diabetic ketoacidosis, which brings you into the hospital and can can result in death, and then over the long term, poor control has a lot of complications, can lead to blindness, kidney failure, neuropathy and disability. And so it's really important to control blood sugars, to keep them in a specific range for those reasons, and there's a lot of evidence suggesting that good blood sugar control can reduce the risk of these complications. So it's, it's, it's, it's absolutely rational for us to make sure that people have access to these drugs. So the way I'm thinking about the the role of public format in this is to solve some of these issues that I see in clinic. So, matter of fact, I can't see, actually, the writing and this, but you can read it.
Kasia Lipska 37:14
Yes. So
Emerald Anastasia 37:16
we saw, you know, there's those, a lot of collusion. There's oligopoly, so manufacturers are controlling cost, the prices, and making insulin for profit. We can disrupt that chain. We can also help by making manufacturing it publicly to reduce the shortages that we're now seeing in pharmacies. These are real. My patients tell me that the insulin is not in the clinic. It's not in the pharmacy. I can't access it, and then less hassles, potentially also with prior authorizations and insurance coverage, when we can disrupt some of these chains. So I really hope that this is our path forward. I think insulin co pay cap stuff are really important, but they have not solved the issue, and I look forward to having more of a discussion with you all.
Christopher Morten 38:16
Thank you so much. Kasha, so next up we have two NYU Law students, Sarah Lamour and Humphrey Shen, who will say more about public pharma as an alternative system of manufacturing and distributing and pricing medicines. Sarah, I'll turn the floor to you.
Sarah Lamour 38:33
Hello, hi. So like Chris said, I'm a student attorney in the Science, Health and Information Clinic, and I'm generally interested in health law. I'm here because I care about access to health and not health care, and also the quality of that care. And so it's been really great to be able to work with t1 i So
Sarah Lamour 38:55
clicker, cool. Okay, so when
Speaker 3 38:58
we're talking about the vision of public Pharma. We're talking about trying to look at the whole picture from manufacturing to procurement, and most importantly, to get the medications to the patients. So it's really important to consider a more comprehensive public system beyond manufacturing alone, just because the main goal is patient access in order to affordably get it to the patients. There's a lot more that actually goes into it than what meets the eye. So when we're talking about a state government manufacturing drugs or doing research and development, we envision a public ecosystem and supply chain where we can get affordable generics to patients quickly, because that's really important, especially with chronic illnesses and so solving these we imagine it solving problems when the private sector can't or when the private sector itself creates those problems. We see public pharma as an ecosystem that's a gap filler to address the failures of the current health care system, like high prices, like opaque rebates and shortages. Include. Seeing artificial shortages also created by the public sector. So when we're looking at the benefits of the public pharma system, we sort of are looking at it in a way that's twofold. The first way is that public Pharma would be able to serve as a public health tool to get medications to patients in need, and to be able to do so quickly. The second way we're looking at it is that public Pharma would reinforce the public sector capacity building and create competition in the marketplace, so a little bit more of like an antitrust angle, so public Pharma would not be profit driven, and rightly so. In the same breath, the increased capacity to manufacture and distribute could be seen as competition, and that would potentially pressure these, you know, mainstays in the game to lower their prices in order to win contracts or bids and just to stay competitive in the market. So as it relates to the first point of getting medications to patients in need, insulin while we're all here today is a prime example of the gap that the private sector leaves that public pharma can fill. It's been off patent, like a lot of people have mentioned, for 100 years already. Yet, there's shortages all the time, and it's extremely high cost. Part of this is due to pharmacy benefit managers, also known as PBMs, that are gaming the system that results in high cost insulin. So it's not just on the manufacturers here, it's also on the PBMs. As it relates to that second point about the public the promise of public pharma and competition, the goal is to get the insulin to the patients, but also to cut out that middleman aspect with the PBMs and to cut out that profit motive. So like I mentioned earlier, this vision is pretty broad, and it could consist of public manufacturing, state distribution and bulk purchasing agreements, or pull or purchasing pools for drugs that people cannot access on their own formularies. And this can be similar to the concept of like a public PBM that negotiates drug prices without the usual profit driven and opaque features that are typical of the private sector. And this is not an entirely new concept. It's not particularly novel. Some components of this has actually been implemented historically and even now. So I'll pass things off to Humphrey to talk more about that.
Humphrey Shen 42:27
Thank you, Sarah, for the great introduction on public Pharma. As Chris mentioned, my name is Humphrey. I'm a third year law student here, and also a student attorney at the Science, Health and Information clinic. So to step back a little bit, this can seem obviously like an unrealistic hope or a dream for the future of the public pharma sector, but I think it's important to ground ourselves in a lot of history here, there are plenty examples of both state and federal government having a significant role in the development, manufacturing and distribution of pharmaceuticals. Many of you may know that the US government is the largest investor in pharma through the NIH, although we're facing cuts these days. But you may not know that state governments are also have in the past and continue to play a huge role in pharmaceuticals as well. So one of the biggest examples is the Michigan biologic products institute that manufactured and sold vaccines to Michigan State residents for free and at cost to other states. From 1925 to 1998 before it was privatized, New York State also manufactured diphtheria anti toxin in the early 1900s that was the precursor to the diphtheria vaccine. And as for current examples, mass biologics, which is formerly owned by the Massachusetts Board of Health and now affiliated with the University of Massachusetts, a public university. It currently develops and manufactures a broader range of vaccines, including vaccines and biologics, including the TD vaccine, as you see in the slide, and also monoclonal antibodies and a range of gene therapies. Importantly for our discussion today, California passed the Affordable drug manufacturing act in 2020 that required the state to contract for and produce its own generic insulin, generic and biosimilar prescription drugs, and that would be labeled under the brand Cal RX. Cal RX is thus far contracted with a nonprofit pharma company called civica to manufacture biosimilar insulin at an affordable price. That is pending FDA approval of its biosimilar insulin right now and under the calor X brand, California has already successfully distributed affordable generic Naloxone with a partnership with a generic drug company called amneal that has a calculated savings of over $28 million for the state currently and just over a year. Importantly, I think calarex gives a roadmap to New York state on how to develop public pharma and how to make it work. California's public pharma initiative has included patient voices, including representatives from t1 international and other independent patient advocacy groups. Through its Patient Advisory Council and its ability to afford to offer affordable generic drugs and promote competition and transparency in a market filled with hidden rebates and corporate consolidation, as Sarah mentioned, public pharma goes beyond just manufacturing drugs. States also can play a more assertive role on the PBM side, state manufacture, state governments, including Washington, Oregon, Nevada and Arizona, just to name a few, have come together to pull their negotiation leverage together and purchasing power through a consortium called array RX. Array RX has been able to leverage these state authorities to offer favorable terms on drug prices for patients and state government purchasers. These are sort of the early steps towards a public PBM system where states can directly negotiate drug prices and facilitate a public pharma ecosystem. This would promote, obviously promote, a more transparent and just system than the current system that chases profits from opaque rebates. So Ray RX is public PBM function is contrasted with the current PBM market, which has been dominated by three vertically integrated companies, vertically integrated, meaning insurers, PBMs and pharmacies are all wrapped up in the same company that have faced both state and federal antitrust lawsuits for inflating the price of insulin. New York now has an opportunity to join other states to begin building a public manufacturing system and to distribute generic drugs expand state capacity to lower drug prices. At large, there's an exciting bill called the New York State drug manufacturing Act, which directs the New York Department of Health to identify generic drugs that are high cost or susceptible to shortage for manufacturing partnerships. I'll pass it over to Max Goldberg from the New York insulin for all chapter who's been studying
Christopher Morten 46:54
and Max before you jump in. Can I just say we've thrown a lot of information at you, but remember that there's Q and A, so don't forget to jot down your questions, and as you develop them, if you hold your card up, I think Liv and Kate will be looking for cards and can start collecting questions
Max Goldberg 47:11
if you have Max Awesome. Thank you everybody for being here. My name is Max Goldberg. I'm a type one diabetic. I am the chapter leader of t1 International's insulin for all chapter here in New York state. So the occasion for this awesome event for everyone here today, beyond our urgent and ongoing need as diabetics for more affordable insulin, is that there is a bill right now in the New York State Legislature, as Humphrey introduced, that will put us on a path towards public Pharma. That bill, the affordable drug manufacturing act, would direct New York State to enter into partnerships with manufacturers to produce our own supply of life saving medicines. The bill, which in its language, calls out some of the precedents for this kind of work that that Humphrey mentioned, whether it's California, Massachusetts or even Michigan, that bill specifically names insulin as one of the drugs that it would produce, but also has the latitude to cover other drugs that Big Pharma is currently price gouging, whether that's inhalers or Naloxone and beyond. So I think what's so exciting about this concept and about this moment is that for as big and bold as Big Pharma can seem on its face, or as public pharma can see him on its face, it's actually a real possibility, and there is a path forward right now, which I can lay that out quickly. So New York state for a little civics, 101, New York State is a bicameral legislature, meaning that we have two chambers, New York State Senate and a New York State Assembly. For a bill to become law in New York state, it has to pass both chambers before going to the governor's desk, where it is then signed into law, the New York affordable drug manufacturing act, our bill, has passed the Senate two years running now, which is awesome news, and that is in large part thanks to the leadership on the Senate side, from Senator Gustavo Rivera, Who is the bill's sponsor and also the chair of the Senate Health Committee. Round of applause for passing the Senate, and while it is not yet passed the assembly in either of the last two years, we are absolutely thrilled and honored to have Assembly Member Jennifer Rajkumar, who is the bill's assembly sponsor, here with us today, and Assembly Member Rajkumar will speak in a little bit, but we know that we will get it done in the Assembly this year too. So while we are thrilled and really, really grateful for our sponsors support, we need more than just the two sponsors, and that's where a lot of us can get to work. So over the last nine months, our chapter, which is a grassroots organization made up of type one diabetics, our family members and loved ones, our allies and also just people who care about health justice, we have been speaking to legislators from all across the country or all across the state, rather sorry with that, all across the state, speaking to them about public Pharma. Why it is such an urgent need for us and for the folks that we have spoken to who are not yet supporters, we found that they generally fall into one of two buckets. So the first bucket are folks who have some concerns about the feasibility of the bill, and again, on its face, that might be somewhat reasonable, right? This is a big swing. It seems like a big change, but with the expertise on this panel, all the precedents that we've spoken about, we know that this is something that is ready to be implemented right now, and that there's good precedent for it, and that we're ready to go. So we feel very well equipped to win over the folks who have concerned, concerns about feasibility. The second camp, and this is the one that we hear even more than feasibility is even easier to win over. And those are folks who just have not heard about the bill. These are people who have told us that they haven't heard from constituents, that they weren't aware, and that they just straight up didn't know that something like public pharma here in New York State was a possibility. So that is where our chapter, and everyone in this room and everyone across the state, that's where we come in, right from now through to the beginning of the legislative session in New York State, which starts in January, on through the end of the legislative session in New York State, which ends in June, we our chapter is going to be talking to every office in the State, telling them why we as patients demand this transformative and life saving and common sense solution to America's outrageous drug pricing crisis, this will certainly be hard work. There's a lot of conversations to have. For one second we are coming into kind of as Humphrey alluded to, a really difficult potential budget circumstance, with all the ridiculous cuts that have been made to healthcare funding on a federal level. And then, third of all, we will inevitably run into the pharmaceutical lobby, one of the biggest lobbies in the country, a lobby that routinely spends millions and millions of dollars defeating legislation that is far less impactful than the legislation that we're going to be fighting for. But all that opposition is no reason to not do this. In fact, it's confirmation that we're doing something that is really worthwhile and really transformative. Before I pass it on, before assembly member rush Kumar speaks, there's one final note I want to wrap up on, which is that a few years ago, diabetics, including people in this room, including advocates at Tijuana International, succeeded in making insulin pricing a national issue, a real disgrace that people really focused on, and in the process of doing that, brought a lot more attention to the larger issue of fatal pharmaceutical greed. Their success, I think, means a couple of things. One, it means that as diabetics, we still command a lot of attention with our stories, with our experience, with the precarity that we find ourselves in every day, and that we can use that for our benefit and to other people's benefit. I think the second thing it means, or what it really is, is that whole success in platforming and sun is an issue, is an example that when we as diabetics are fighting for ourselves, we're really fighting for everybody who lives their life at the whim of pharma's profit motive. And so that's diabetics, that's cancer patients, that's people use inhalers, HIV patients, everybody. And I think that kind of takes us to this moment where I see in New York us fighting and winning public pharma as something that goes beyond New York State. It goes beyond insulin pricing. It goes beyond drug pricing and the cost of drugs even is, I think, and I think it will be a testament that when people who are fed up with this illogical and totally broken and absolutely brutal health care system, that when we come together, we can win something that changes the entire game, and I think it'll be a real shot across the bar for the entire country. So we are thrilled to be doing this work. We'll be outside at the chapter. Please come up and talk to us, and we'll happy to plug you in. And I'll pass it back to Chris with that. And soon, Assembly Member Rajkumar,
Christopher Morten 53:59
thank you, Matt.
Christopher Morten 54:04
And really quickly, I think if you're interested in the New York insulin for all chapter, I think this is also a QR code that will take you to to more information. And with that, Assembly Member love to have you say a few words.
Jenifer Rajkumar 54:21
Okay? We are going to do it. We are going to manufacture generic life saving drugs here in the state of New York. Yeah. So what now costs? As our speakers have said, over $300 sometimes $1,800 of oil, of insulin will will cost $30 once we do this, what now cost $40 for Naloxone will cost 250 what now cost $600 for an EpiPen will cost $60 and what now cost hundreds of dollars for. Basic antibiotics will cost just a few dollars. And this is our goal, making life saving drugs affordable and putting life saving medications in the hands of all New Yorkers.
Speaker 2 55:13
Yeah,
Jenifer Rajkumar 55:17
so I'm State Assemblywoman Jennifer Rajkumar, and I introduced the affordable drug manufacturing act to make this vision a reality here in the state of New York. Full confession, I grew up in a family of all doctors, and of course, as a non doctor, I am the family disappointment, but as a lawyer and as a lawmaker, as I told my mom, I can be a doctor for the whole state. That's we're going to do. So let's get this bill passed so I can keep my promise to mom, but I invite every single one of you to join me in this nine month movement to get the bill passed at the legislative session, as Max told you, starts in January, it ends in June, and before that, we have to organize, we have to strategize, we have to come together, and we have to build a movement so that we are heard, and the bill can get passed. It can get done. I've passed hard bills so it is possible, and I'm so glad to be here with you, because I've heard from everyone here. You've given me the confidence that we can do this. This is not just my bill, but it is our campaign. It is our movement. It's our fight for fairness. I grew up hearing from my family, of all doctors, stories about patients who simply could not afford the medicine that they needed. One in four Americans cannot afford the prescriptions that their doctors prescribe. Insulin, the very definition of a life or death drug, as we heard here, is way overpriced. People are forced, as we heard, to ration or to skip their medicine. Some die because of it. That is not acceptable in America. And the problem is not high manufacturing costs, that it costs too much to create these drugs. The problem is simply market failure. There is not enough competition in the market. Only a handful of companies are manufacturing these drugs, even though nearly 90% of prescriptions are generic with so little competition, Big Pharma can price gorge, and they can do it even with old cheap to make drugs like insulin, like antibiotics, like epinephrine. These drugs, as we heard, cost just a few dollars to make. This is not innovation. It is monopoly abuse, and that is why I introduced the affordable drug manufacturing Act. This bill creates competition by letting New York manufacture or partner with other companies to produce generics. It is a market based fix, breaking monopolies, lowering prices, stabilizing supply. And let me be clear, this is not a government takeover. The American Medical Association actually supports this approach, and they have opposed public health care expansions in the past. That's one example, just showing how mainstream and practical the solution is. This is a bipartisan common sense reform. It is not about ideology. It is about fairness, competition and saving lives. Conservatives should support it because it prevents monopolies, reduces taxpayer costs and strengthens the free market. Progressives should support it because it makes medicines affordable, addresses inequity and protects our most vulnerable. This is a bill for all of us, because no matter who you are, you deserve affordable medicine, and you deserve access to affordable medicine, and we know it works. In Sweden, the public drug manufacturer APL is so successful that it exports to 35 countries and pays a dividend back to its people. Here in New York, our Department of Health spent 13 point 5 million on Naloxone last year, if we produce it ourselves, we could buy 16 times more doses for the same money, and that means 16 times more lives saved. We will save both lives, and we will save taxpayer money. And the benefits go beyond cost. With no profit motive. We won't push unnecessary drugs just to chase profits. We won't abandon unprofitable drugs that patients still need. We can address health disparities by making sure all communities have access. We can scale up manufacturing in emergency situations, and we will. Create jobs right here in New York. No one in New York should be forced to skip the medicine that keeps them alive. With this bill, New York will lead the nation, and together, we will build unstoppable momentum. Together, we will win, because everyone deserves affordable medicine. Thank you so much for joining me in this moment.
Speaker 1 1:00:28
Thank you. Wow.
Christopher Morten 1:00:32
Thank you so much, Assemblywoman for being here and for for your leadership of this bill. And thank you again to all of our speakers. I think we have a little bit of time for Q and A yes and lib Do you want to take the mic? Do you have some questions in hand?
Humphrey Shen 1:00:45
Okay, so we're not going to get to all of these. I've got a whole stack of questions. Thank you. These are all excellent questions. I hope that you will scan the QR code so you can get in touch with Max. If we don't get to your question, please do follow up with the chapter. So the first question is, actually, well, that's okay, we'll get to it later. Um, the first question is, What role have patients had in public Pharma? And what role should we have?
Allison Hardt 1:01:17
I can speak a little bit to that. And I think, as Chris kindly said at the beginning, I currently am on the Patient Advisory Council for the calor X program in California and and I think what you've heard here tonight, hopefully has, I mean, I'm feeling super inspired, and I kind of marinate in this all day, every day. It's just really amazing to hear people's stories. And I feel like when patients are the ones that are at the table, they're the ones that have the most at stake, and there's the urgency, because their lives are the most impacted, and patients are also the experts. So if you're in this room and you have that lived experience of having a chronic illness or needing a medication, you have an expertise that other people, other stakeholders, policymakers might not have, and we see this time and again as people who are doing doing this advocacy, that that knowledge is really invaluable in shaping how legislation comes together and where the focus is. So this conversation tonight is a culmination of So, I mean, I think you've heard, but just like so much advocacy, so much work already, and building that momentum, and we have to be doing it together. And I think when we can speak directly to the lawmakers who are who are championing this work, we're also able to help them understand that urgency and and the real challenges that people are facing. You know, emerald story is not abstract. Shana's experience. It's not abstract. It really grounds us and why this is important, and helps people understand why, why the cost of inaction is far greater than, than, than the price tag that it might have. And so anyway, I think that when, when people who are most impacted are the ones who are at the table that that just really helps us improve outcomes as well. So how this has taken shape in California is that with calor x, we advocated and have established the patient advisory council, which establishes kind of a two way communication between Cal or x, which is the program, the state led, piece of the program, and then civica, who is who they've contracted with for the insulin so that we have, again, open communication and are able to provide experience and and feedback on everything from the distribution plan to making sure that those who are really the most at risk, whether that's houseless folks or people who are in insulin deserts, maybe helping understand places they wouldn't have been looking before, to ensure that there is really equitable access in the program, again, because people have lived experience and can bring that to the table. And so that's just been really, really beneficial. Another way this has taken shape is in Maine, where they were similarly exploring something like this. They established legislatively, a commission to look into the feasibility of producing insulin there, and that also was somewhere that patients were able to inform and really direct that conversation to the pieces that were really most important. So I just think it takes it from being something that is more abstract, and again, grounds it in our stories, and helps to make sure that the problems that are being solved are the ones that people are really facing at the pharmacy counter in real life, and not abstract. Or yeah, I think that's what I got.
Humphrey Shen 1:04:37
Amazing. Thank you. Allison, the next question, and I'm trying to group these together to see if there are like questions that kind of go together. So how can we get involved in the momentum to pass this legislation? And then there was a question for the assembly member who she had to run. But so if that was your question, no. That I read it, and then we'll follow up with her. But similarly, along those lines like, how can we actually get this legislation to pass in the coming session? And that's kind of max so I laid it out a
Max Goldberg 1:05:16
little bit with there are two chambers we need to pass in both we have amazing support from our two co sponsors, but we need a lot of other legislators who will be doing that. And I think a lot of that lift will come from us, will come from regular people, calling legislators, visiting their offices, and kind of demanding this as a solution. One way you can do that is through our chapter, through t1 international. So like I mentioned, we will start before January, when the session opens. We'll go all the way through June, but we will be like bringing it every single day. I think some stuff that we have planned that anyone here can tap into is we will be doing a lobby visit up in Albany to state capital in early January to kick off the session. We will be doing tons and tons of office visits and legislator meetings after that. And we will be doing another key part of it is like telling our stories as patients or as allies, as advocates. Our chapter is going to run a training for folks who want to kind of work on how they tell their story, work on their advocacy, advocacy skills. So getting involved is in the chapter is just like an easy first stop way to do it. And the last thing I'll say about that is, if you are someone who maybe does not have experience with advocacy, or has not done this kind of work, has never spoken to a legislator before, don't worry, because that is all of us. Our organization is really blessed with a lot of wonderful resources that make this very easy. So NYU and the support of the chick team is definitely one of them. We have seasoned advocates who know the legislate, the legislature, inside and out, like carland Carlin, who I want to shout out, but if you haven't done this work before, it is easy to get involved, and we have a lot of resources to make folks like this, feel a little bit easier. So scan the QR code, talk to any of us after the fact and jump in
Humphrey Shen 1:07:07
Cool. Thank you, Max.
Humphrey Shen 1:07:10
I'll just say if you want to go to that storytelling for advocacy training that is going to be run by emerald and Bridget, who's also here, that's on the backside of your form. Oh, yeah, Bridget, who's right here, so sign up for that. Okay, so the next question, I think that would make sense here, is, what about legal challenges from the pharma industry? And I don't know if our law students want to take that or whoever, Shaina legal challenges from the pharma industry.
Christopher Morten 1:07:41
Or perhaps I can take that one, I don't know, Sarah and Humphrey look like they're dying. I'll jump in first, and then you guys maybe amend or add to what I have to say. So that's part of, I think what we in the law clinic here at NYU have been doing even before I think I started representing t1 international have been in kind of the wider context of the access to medicines movement. We have some leading lights of it here tonight. Peter maybe Duke, Public Citizen, for example, thinking about procurement by public bodies at the federal and state and municipal level. We heard Dave Chokshi talk about what the state was doing and the City in the early days of covid. So we've kind of had various puzzles to solve along the way of, how do you overcome I don't know challenges like this is impractical or it's not permitted by administrative law, or maybe if we do this big enough and make enough of an impact, we're going to face lawsuits from the pharmaceutical industry or other incumbents who don't like alternatives to the current system. So just to say, kind of in connection with the history that I think Sarah and Humphrey and others started to share right like, this is not a pie in the sky dream. This is actually already happening, and has happened for many decades. In conjunction with that, there's a history also of the kind of legality of this, how we structure it, how we regulate it, and so on. The last thing I'll say is, like, we started to think about, like, specific challenges that might get brought against a public procurement and distribution initiative, like the one New York State is considering, or like, what's already underway in California. So far, the big three insulin manufacturers and the PBMs and others, they have not challenged what California is doing. And my take as a lawyer is they're not challenging it, not because they don't want to, but because they really don't have a great basis on which to challenge these things. Governments, generally, this is like antitrust doctrine, and folks can jump in if they want, but like, governments are allowed to be market participants. You can have a state owned company competing with for profit private companies, and that's kind of one way to think about what's happening here. So it comports with antitrust law, it comports with other doctrines. So basically, we think it's legal, but as these programs scale up, then maybe product starts crossing borders and things get more complex, there might be challenges that emerge, and that's part of where I think lawyers can be. Really useful. So folks in the room are lawyers or law students. I know there's academics and there's lawyer in civil society who are thinking about this together, and we would really appreciate the hope and Humphrey and Sarah, anything you want to add
Humphrey Shen 1:10:16
to that you might get a chance on this one. Humphrey and Sarah, because just you mentioned antitrust. So I'm going to read a question that's about antitrust. Why have current antitrust laws been ineffective against insulin manufacturers?
Speaker 1 1:10:30
How much time do you all do you want to take a crack at that? You can try. I mean, there.
Christopher Morten 1:10:40
I don't, I'm not an expert on antitrust law, first and foremost, so it's incredibly like, bringing a winning antitrust case is really hard, even when things are simple. And I'm like, tempted to go back to that slide of, like, the super complex network, the web, of like, you don't just have manufacturers, but you have PBMs and wholesalers, other middlemen. You have insurance companies, you have pharmacies, and so when you have that, when you have that complex mix of different actors, it's really hard to pin liability or misconduct on any one individual. I see Shweta Kumar, Professor Shweta Kumar, nodding, so that's a relief. I kind of want to pass the mic to her into some of the other way. But so there are antitrust cases pending against these companies, for example, like antitrust claims brought both against the PBMs and the manufacturers for their role in inflating the cost of insulin. And that's one clever move, I think, is to pin the same like the PBMs, the pharmacy benefit managers and the manufacturers in one case, so they can't just point their finger at the other like you're all stuck here in the same litigation, fighting it out with the FTC and with state attorneys general and so on. But these cases are still really, really complicated, and proving that there's like knowledge of an intent to monopolize, intent to overcharge, it just gets really hard. So I don't know. I wish we had a lawyer from like the FTC here and Shaina, yes, please.
Shaina Kasper 1:11:56
Can I not answer this legally? But just like politically, is just to say the pharmaceutical companies that we're up against. The pharma industry is the largest industry the world has ever seen. You know, like, there are three pharma lobbyists for every member of Congress there. There's such a huge force to be reckoned with that it makes it really hard to go, to go up against them. We're doing this really incredible task of of calling them on their on their stuff. And it's not just yeah, like the lack of trying to the FTC has put this, this investigation in for for the insulin manufacturers and pharmaceutical benefit managers, their PBMs and to international was subpoenaed as part of that, you know, like, this is, this is absurd. Like, these huge, I don't even know how big of corporations they are, are subpoenaing us, you know, like our, we're, we're like, a bunch of volunteers working on passing policies to make sure people can get insulin that they need to live. It's really absurd, and it is a threat to democracy that these companies have such a big amount of power, and that's what we're, you know, here, to fight up against them. I
Speaker 3 1:13:16
was just gonna say one more thing. It's not like super profound, but I think it also is just dependent on the administration and what their priorities are. And so because of the changes that happen, their priorities change. And so what we were really excited about last year, like, it's not happening anymore until so you have to, like, sometimes just like, wait it out, or, like, you know, act in different ways in the meantime.
Speaker 4 1:13:38
Yeah, I'll also add, I think there is a potential where pharmaceutical companies get sued, either by private plaintiffs or by the government, that they would just settle out pay like a huge sum of money to make this lawsuit go away. But it doesn't solve the structural problem that still exists. I know this has happened in the opioid crisis, but it happens very often with the pharmaceutical companies.
Humphrey Shen 1:14:06
Thank you guys. So I think the next one that maybe makes sense in the flow of the questions is, in your experience, what has been the hardest aspect of convincing state stakeholders to get on board with public Pharma? Yeah,
Max Goldberg 1:14:28
I can speak briefly from a New York perspective, but I feel like the California perspective here would also be really helpful. I think the two things that I mentioned are the things we hear the most is there's concerns about feasibility, and folks who just haven't heard about it. On the feasibility front, the one thing I didn't mention when we spoke is that, in addition to all or when I spoke earlier, in addition to all the precedents that I mentioned, there was also feasibilities studies done in Maine on a similar program. So we. I'm very well equipped, I think, to answer those concerns about feasibility and in terms of making sure that people have heard about it. Sorry, our chapter was relatively new last year. We started around the turn of the new year, like when the session was already in full swing. So I feel like with all of our momentum, with all of our allies, we are very, very in a good, very much in a good position to make sure that everybody who had not heard about it last year hears about it this year. So outside of those two concerns, we haven't come up against a lot of other opposition, but next year is a new year, so we're going to talk to way more people, and I'm sure there will be more that we hear from, but that for us has been the main thing thus far.
Max Goldberg 1:15:42
Yeah, I don't just quickly to add, I don't know that this is yeah to use, to use your phrase too profound, but the California example is a little bit different, because there was such strong political will to make it happen that there really wasn't too much opposition. There wasn't any it moved very quickly, but I think where, where people do have hesitancy, like Max said, it really is about the the feasibility and the cost, and I think it's really important. I mean, we've already heard this in so many different ways tonight, but I'm just gonna, just gonna hammer it home the like that. We need to reframe that, because it's not, it can't just be about the bottom line and thinking about it being too expensive. There are just so many things in our society that we invest in as public goods, if it's education, if it's libraries, if it's other basic services, utilities. I know we're in this moment of kind of scary and extreme privatization. We're all seeing the effects of that. So I think we want that hope, that there is a belief in those collective beneficial things, and that is what medicines that are essential should also be for. I mean, I think just having that public good, as Dave said so nicely, but I think that's really it is just people haven't heard this argument, and I think there's so much momentum building now that's super exciting. And it's kind of, it's kind of the job of people to keep making that noise. And one of the biggest things with moving legislation, a lot of times, it's like, the people just don't either understand the urgency of it, or they haven't, like Max said, haven't even heard of it or realized it. When you're in a session, there's so many bills on the table, and so it's really the job of advocates to be making the noise and drawing the attention, and it's wild what like, a handful of people can do for real. Like, I think that's like, we are a testament to that every day. And it's really, I'm like, getting a little choked up, because this is, like, a really beautiful thing to see so many people, like, super in it. And like, I feel like it's really building. So, yeah, I'll just say that.
Humphrey Shen 1:17:50
I feel like that would be like an amazing place to end, but we do have time for a couple more questions. So that was inspiring. Thank you, Allison. And speaking of California, can you talk about the regulatory hurdle that Cal RX and their contract manufacturer are facing, and the pros and cons for New York to also do this rather than purchase Cal RX insulin?
Speaker 2 1:18:13
Yeah, I don't know,
Christopher Morten 1:18:18
and I can try and help you with that. Take a first crack if you want. Or I'll say first I'll just say, as a lawyer, often we worry about we're like trying to spot issues and solve problems before they present themselves and and and stop good things from happening. And so one of the things we have worried about from the start is that public Pharma is subject to the same regulation that private Pharma is. So if you want to distribute drugs to people, you pretty much have to deal with the FDA. And so a public drug procurement or public drug manufacturing initiative, you're making insulin or Naloxone or any number of other drugs, you've got to figure out FDA regulation and running clinical trials and doing all the other testing and submitting the very complex information that the FDA needs, is expensive and complicated and slow, and you need that expertise, and so I think that's one reason that Cal RX has taken some time to get its insulin to
Max Goldberg 1:19:16
patients. Thank you for having that addition and for buying me some time for my brain to process that question, because I do think a couple other things about specifically that one to be clear about the timelines, one of the things that caused delay was that originally, Cal RX was looking at, or civic rather, was looking at just doing vials, and they realized they needed to do pens, because pens are the method that people use more. And that realization was from talking to patients and understanding that the delivery mechanism to take their insulin, they needed to be able to deliver on pens as what people were using now, and not just vials and syringes, so that to make the pen mechanism is a different, a whole different thing. And so it took more time to be able to get there. Yeah, to Chris's point, the FDA regulation is a time like, takes a lot of time, so that is definitely a thing, but that was kind of one of the pieces of the puzzle. And I think just to Yeah, hopefully that illustrates just why it's so important again, whether it's with insulin or with any other disability or chronic illness or what that people that are experiencing that are able to share that feedback, because ultimately, we'll all, I think it'll be a much better result that they are able to deliver on the way that people actually want to be able to take their medication, rather than just having one way. So that all
Humphrey Shen 1:20:39
right, I think we have time for a couple more. So this one is, what is the relationship between public pharma programs and PBMs and insurers? So glad I'm not on this panel.
Speaker 4 1:20:53
I can take a crack at that. So even if we had sort of like a public pharma manufacturing system. I think the problem obviously runs into the fact that pharmacy benefit managers are the ones who traditionally negotiate with manufacturers, insurance companies and pharmacies like a three way middleman of sorts to get the actual drug from the manufacturer to the pharmacy counter. Funny enough, they don't actually touch the drug, but they just touch the prices of the drug, but they're usually the ones working with your insurance coverage to do so I think calarex right now is direct to consumers, so it doesn't work within the insurance system. But as we're thinking about this public pharma ecosystem, we want to make the public pharma system work within pharmacy benefit managers who want to get this out to people with insurance so they can lower insurance premiums, lower out of pocket costs, things like that. So I think it's really important to understand that even if we have a public pharma manufacturing system, we need to have like employers states get involved in like a public PBM system to get the PBMs to prefer low cost generics, which they don't really want to do right now because they make profits off of the middlemen scheme, plus
Christopher Morten 1:22:18
plus one to Humphrey's point. And I'll just say, Really, okay, so quick, and then I'll ask another question. I think one of the insights of the lawyers working with the advocates who are leading public Pharma is, I, at least a few years ago, was like, public manufacturing seems so exciting. If we can just get a nonprofit drug company making safe and effective drugs and giving it to patients like Won't that be a huge boon? And it is, I still believe it is. It will be. But most patients may not benefit, unless and until you crack the for profit, PBMs, the for profit insurance companies, all these other actors. Because if you're on private insurance, if you an employer, and private employer provided health insurance, if you are on an Obamacare plan. If you're on a whole range of slew of plans, you may not have access to the low cost, publicly manufactured product through your insurance, and then you face a difficult choice. You can pay completely out of pocket, or you're going to stay in the kind of captive system. And so the problem gets bigger and bigger the more we study it, but that just is more fun puzzles for us to try and solve. Amazing.
Humphrey Shen 1:23:24
Okay, so I think this is going to be our last question, but all the questions in the stack are amazing, so I hope we will get to answer them together as we keep working on this. But this one is in the current environment, with federal government failing cities and states budgets, and the need for cities and states to balance budgets. What are the economic impacts? Thinking jobs created, productivity increases from less illness, etc. So it's a economic impacts question of public Pharma.
Speaker 5 1:23:56
I'll just quickly say I think we heard from Assemblywoman that the projected savings, and I know that it was reflected, I'm sorry. I'm forgetting who said it, but the calor X program, they have, like a tracker on their website that shows you, in real time, how much money they've saved. So like on their Naloxone procurement program, it's, I think, Oh, is it right behind me? Magic. Thank you. Look at that. It's 28 point 8 million. So, so the again, like, because, because it's not just an individual burden, which we've heard is super hard, but it's also on, on governments and on our whole like, everybody is being affected by this. It's so expensive for state governments to be getting their government, or they're getting their government, getting their their drugs at these prices that the they're kind of held captive to from from manufacturers, who, again, are designed like they're doing their job. They're supposed to make money, and they have a bottom line. So that's where we just really want to, like, not have that profit incentive be what is, what is behind the motivation to get people their medicine. So, yeah.
Christopher Morten 1:25:00
Yeah, can I say one more quick thing? I guess I can't, because I'm in charge, though nominally, plus one to what Alison said. And also, for me, at least part of the longer term promise and the excitement of these public initiatives is all of that savings to people who pay taxes, to all of us. But also, I think the question referenced like job creation, right? This is, in some sense, like industrial policy. It's creating high paying jobs. It's creating more stable supplies of medical products that we need so we're not susceptible to shortages caused by like global supply chains. Remember, covid, it's a way for New York, potentially and already in California, like the California legislation, the caloric legislation, was enacted with support from labor unions there, because they might bring great manufacturing jobs and R and D jobs, and the state, at the time, said, we're going to try to put the manufacturing and then some of the R and D into the Central Valley, into parts of the state that could really benefit from the economic boost. So I think there's all these kind of synergistic benefits, and I see public pharma as part of the broader kind of campaign or struggle to recapture some of the infrastructure that we need to live energy and housing and all of these things. Right we see in New York City right now an effort to revive public housing and to take more ownership of energy production, like public Pharma is very much in league with that for all the reasons that we think about public infrastructure elsewhere.
Max Goldberg 1:26:26
And one quick thing I'll add, when we think about public pharma in New York state against the backdrop of general federal chaos, is that I think it's an opportunity, if we succeed, to show people that the government that they pay taxes to can actually deliver for them like we know we, many of us, feel either very little faith or total despair when we think about what's happening on a federal level and what our tax dollars are going to this is an opportunity to give people like a direct benefit, where people who need life saving medicine are getting good medicine from the state, and therefore feel connected to the actual government that they're paying to. So as the federal goes the way it goes, I think we have an opportunity here to show people that there is something to actually like invest in.
Sarah Lamour 1:27:13
And believe
Christopher Morten 1:27:14
it, okay, I think that's all the time we have. So just so quickly, one more round of applause for our speakers, please, and for lib and Kate, our excellent Q and A facilitators. Thank
Announcer 1:27:34
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