[r3trohack3r]

> Though insulin generally costs less than $10 per dose to produce, some versions of the drug have a list price above $200. This is in part because, in the US, a warped market has allowed three companies to dominate the insulin business.

> With California leading the way, a handful of states are considering trying to disrupt the market for essential medications, starting with insulin. The plan would be to manufacture and sell insulin themselves for a price that is roughly equivalent to the cost of production.

I feel like I'm missing something here. My understanding of why insulin is so expensive: laws are created and enforced by the government preventing people from competing in the space.

If you try to make your own insulin, and you take it to market with 3rd party analysis and certification of it being medical grade (and safe) insulin, you'll start seeing an escalation of the state against you. First angry letters from lawyers and eventually, if you continue head strong and ignore everyone telling you to stop, government officials (possibly with guns) will come and forcibly shut you down.

Is California just going to ignore these laws? How will the state not be liable for damages when individuals are?

I'm all in favor of revoking the legal structures that pick the winners in this market. It seems like there are plenty of people passionate in this space that would/could make insulin at near-cost if permitted to.

It's just that, by my understanding, it's the government that doesn't permit them to. It's weird that people in the government (at the state level) are stepping in to do what people in the government (at the federal, but possibly also the state level?) won't let people in the market do.

Edit: substituting “intellectual property laws” with “laws” as it seems there’s more to it than just IP.

[projektfu]

A lot of formerly protected insulins, e.g. insulin glargine, are off patent now. The remaining moat for generics consists of FDA approval, delivery system patents, and manufacturing process patents/trade secrets. For a generic insulin to get FDA approval it needs bioequivalence which is a lot like running the original safety and effect studies over again, while dealing with spurious injunctions and the like from the company with the name brand. If you get to the finish line as a private company, you're going to price it where you can get some of the market but not get into a price war with the name brand.

California, on the other hand, is paying a lot of money to Novo Nordisk et al, and would benefit from reaching a low average price. They can afford to go through the approval process with all the important insulin analogs. And they won't go bankrupt in court before it pays off.

[basch]

>insulin glargine, are off patent now.

In the U.S.A. is expected to expire on 2027-07-05.

How did something invented in 1994/2000, get patented in 2009? https://patents.google.com/patent/US8048854B2/en%3C/

[projektfu]

That's a different molecule. It's been animated.

[basch]

Do they still make/prescribe the non animated one? Did it just disappear off the market?

[projektfu]

I think that's just a Wikipedia red herring. I'm not sure the amidated glargine has been marketed.

[RcouF1uZ4gsC]

>. For a generic insulin to get FDA approval it needs bioequivalence which is a lot like running the original safety and effect studies over again

That is incorrect. A bioequivalence study is much simpler and cheaper than the original safety and efficacy studies.

You do not need to prove that safety and efficacy of the drug, only that you are delivering the equivalent of the originally studied drug at the same doses.

https://en.wikipedia.org/wiki/Bioequivalence

[peyton]

No, the submission packages for anything chronically administered (like insulin follow-on) are way more comprehensive.

[projektfu]

Thank you. Insulin, being a biological, can't prove equivalence through just equivalent pharmacokinetics and contents.

[rayiner]

> I don't understand. My understanding of why insulin is so expensive: intellectual property laws are enforced by the government preventing businesses without that intellectual property to compete in the space.

That’s not an accurate understanding of intellectual property specifically. Insulin isn’t like a pill, where once you have a chemical formula you can make millions of them very cheaply. It’s a biologic, an artificial hormone. Even leaving aside the patents, it’s very expensive to get approval for a generic biologic (called a biosimilar). That’s why there are few manufacturers of synthetic human insulin, even though that’s out of patent.

[ProjectInsulin]

Hi Rayiner, you are spot on with your analysis. My name is Eric, and my non-profit, Project Insulin, is tackling this problem head-on as well. We are developing a biosimilar insulin and will distribute it directly to patients at cost. The drug development process is still expensive but much cheaper because of the Biologics Act that was passed in 2020. When going through the FDA approval process, biosimilar insulin makers don't have to do phase 2 trials, and their phase 1 & phase 3 are focused on interchangeability with the reference product rather than proving that insulin is a way to lower high blood sugars.

Another obstacle, as you pointed out, is that there are few manufacturers who produce synthetic insulins. From what I've learned in my discussions with manufacturers is that many are transitioning their facilities to a focus on mRNA drug manufacturing. Therefore there is a limited set of manufacturers who don't make insulin but have the equipment/facilities for it (in the U.S.).

[coldpie]

Hi Eric! I'm a T1D and so super interested in this space. Can you comment on whether it is the case that "modern" insulins (Lantus and Humalog/Novolog, in my case) are both covered by current patents, and also considerably better for patient outcomes (faster acting, more predictable -> lower A1c) than non-covered insulins? That is my understanding for why cheap, high quality insulins are not available, but I'd love to be informed if it is not the case! Thank you for your work in this area!

[MAGZine]

(not OP). some quick googling reveals lantus is no longer covered by patents. patents in the usa last 20y, and they filed the main patent for that drug in 1994.

it looks like they tried to patent some pen injection mechanism as a way to artificially extend the patent, but the patents were tossed out. I think that's a similar approach to how the Epi-pen people have maintained control, except their pursuit was successful (epinephrine isn't exactly a new chemical, nor is the process for manufacture).

still--manufacture of these drugs is long and expensive process, esp with fda approval. new entrants want to recoup their cost. the public is a great institution to develop generics because it can happily do so without a profit motive.

[pkaye]

I think Humalog/Novalog patents expired a while back. These companies will probably focus on other newer drugs for profitability like Semaglutide which is useful for dealing T2D and obesity.

Another thing that needs to be investigated is how much the PBMs (Pharmacy Benefits Managers) prpfit from the spread of drug pricing. Are they marking these drugs up a lot? Do they need to be tightly regulated?

[kridsdale1]

Jokes on them. I can buy raw semaglutide powder two steps off a Google search at 10% of retail.

[ProjectInsulin]

Hi as some of the others have already mentioned Lantus is off patent. My organization is focused on insulin glargine but there are generic versions of insulin lispro and aspart. Which is the generic/biosimilar version of humalog/novolog. We decided to stick with glargine first and transition to the other versions as we progress.

[hertzdog]

Hi Eric, my name is Francesco. In the last three years we industrialized a novel method for producing biosimilar insulin (in Italy). We are an international team and I really would like to contact you. Can you write to the email you find on my profile?

[ProjectInsulin]

Hi Francesco looks like you found me! I will respond to your email shortly :)

[atlasunshrugged]

Hey Eric, somewhat tangential question -- why is it that seemingly all precursor manufacturing is done in China or India? Is it just a low-cost game or are regulations making it too expensive to do in the U.S. or something else?

[ProjectInsulin]

This is a great question. Simply it is a lot cheaper to make drugs in China + India. The APIs cost less, and the workforce is cheaper. With regards to regulations I don't want to generalize but it has been well documented that it is hard for the FDA to regulate drugs being produced outside of the United States.

[6nf]

Why is insulin not expensive in other countries?

[ProjectInsulin]

While I don't know the answer to this in-depth I can share some bullet points and of course it depends on what country you are talking about. On top of that it is important to note that there are insulin shortages in various countries.

- one payer healthcare systems - non-convoluted distribution systems - depending where cheaper workforce/cheaper to make the insulin - less stringent regulatory processes - stronger lobbying groups in the US

[6nf]

There are no shortages in Australia, only the Eli Lily brand is low in stock but all other brands are available.

I've never heard of anyone unable to find insulin in Australia.

https://apps.tga.gov.au/Prod/msi/Search/Tradename//53488

[rayiner]

Very cool. This is much needed.

[basch]

People dont want insulin (traditional insulin.) They want fancy insulin (modern insulin), because it is convenient. They want modern rapid and long acting insulin. They want pens. Maybe people want the inhalable powder. Those innovations exist outside the original insulin patent. They are also mixing other drugs with the insulin.

>Average retail prices of Novolin and Humulin (traditional short- and intermediate-acting insulins) have gone down, or held steady, while prices of modern rapid- and long-acting insulins continue to go up. On average, traditional insulins now cost less than half of what modern insulins cost.

https://www.goodrx.com/healthcare-access/research/how-much-d...

There is a lot more going on that makes high end insulin expensive. A lot of conversation around insulin is people talking past each other because they are referring to different things that they think should be free, usually one of these additional features on top of the hormone itself.

[ksaun]

I do agree with the statement that some of the language around the lack of insulin availability is misleading, but it's not just that it's more convenient. "Fancy" insulin allows one to better manage blood glucose levels. Poorly managed blood glucose strains various organs/systems in the body and over years and decades leads to various health complications, some resulting in death. (It's still a lot of work and stress -- modern insulin isn't an automatic improvement; but it does allow greater success in managing diabetes.)

(My comments here are in the context of type 1 diabetes. The (potential) positive health impact of modern insulin may be less pronounced for other diabetics.)

[basch]

I dont mean to be dismissive or elitist. There is enough wrong with the medical system, that if somebody loses coverage and needs to see a doctor to get their prescription changed, that change alone becomes insurmountable, behavioral change not included.

My rub is that the conversation is dishonest. Saying "access to insulin is a right" and then changing the topic to modern delivery methods and such. Call a spade a spade, and have the direct honest conversation the first time. My pertubement goes beyond this topic into social justice/political correctness and just about anything. I may believe in the cause and the result, but be dismissive of how to get there by cheating and hacking peoples attention spans. It seems the only way to be an activist and get attention is to start with a lie, and now everybody is competing for the most inflammatory headline.

Everything you said is the conversation everybody should be having, instead of truncating it to "insulin is way too expensive."

[wanderingmoose]

I think a big problem is that short acting insulin, which was available 25 years ago, used to cost $9usd / 10 mL bottle now costs ~$80 with insurance (in california) or $200+ list price for an effectively equivalent short acting insulin. (numbers were from my insurance statements which include the cost for current prices, and from a family member who was on the pharma board at one of the large managed health facilities in california in the 90s.

To me, that cost inflation is purely artificial and not driven by any new tech relating to the insulin itself.

For T1 diabetics, the cost increases have been moving to insulin pumps which have infusion set costs in addition to the actual pump, and for continuous glucose sensors.

[basch]

Are you sure about this? 25 years ago, rapid insulin would have still been under patent.

Is anybody buying short acting anymore? At those prices? Rapid onset is $72.88.

https://www.walmart.com/cp/3769564

That's basically a 4.4x increase, after inflation to jump from short to rapid. Not saying its justified. Why pay $200 list for something that is less than $80.

[bombcar]

Yeah, you can do some quite easy motte-and-bailey with it.

Everyone will agree that (cheap, out of patent) insulin should be available to all; it's literally lifesaving.

But then switching that to the (modern, convenient) insulin should be available to all is a bit of a slight of hand, especially when it is NOT a "you will die without this" but a "you will have more hassle taking medication to not die" scenario.

[spiznnx]

I do want to bring up that insulin management is extremely taxing to individuals, and hard to get right. See https://news.ycombinator.com/item?id=30376777 for previous discussion.

Obviously the costs involved in implementing these technologies should be part of the discussion, but I don't think it's unreasonable to want to make anything that eases management of diabetes way more affordable.

[basch]

Which is what the conversation should be, and how it should be framed.

The press writing "life saving insulin" headlines takes away from the ability to discuss that: within the last decade or two, modern improvements made the process of managing diabetes significantly easier and else stressful. The drug companies gave everybody a taste of an easier life, and then jacked up the price, saying "pay us more or go back to the old way." At what level should the government step in and subsidize or control this quality of life improvement? At what level should its creators be rewarded?

I am old enough to remember when the entire world took traditional insulin. It wasn't pretty.

[ProjectInsulin]

I would like to point out that these fancy insulins have been around since 1996. I do agree that there is cheaper insulin available, but as others mentioned there is a significant change in quality. But I agree with you that the conversation should be affordable high quality insulin.

Another piece of the insulin ad drug saga that I haven't seen many people discuss here is the distribution of drugs. The distribution from manufacturers to patients is incredibly inefficent with a variety of middle organizations increasing the cost associated with distributing the insulin and those costs are pushed down onto patients. Our website has a simplified graph showing the current model vs what we plan on doing: https://projectinsulin.org/why-insulin/

For a more in-depth look the Wall Street Journal has a great video from 2019: https://www.wsj.com/video/series/news-explainers/how-drug-pr...

[dmitriid]

> At what level should the government step in and subsidize or control this quality of life improvement? At what level should its creators be rewarded?

You assume that creators are rewarded.

In Sweden you get the insulin and pens for free (that is, you've paid for it with your taxes).

[basch]

Novolin 70/30 ReliOn vial (10 mL; 100 iU/mL) has had a flat price since 2014. The Novolin 70/30 ReliOn FlexPen (3 mL; 100 iU/mL) pen has been the same price as the vial since mid 2018 when it came out.

The price of these drugs NEVER went up.

Framing it as only "more hassle" or "purely convenience" really downplays the difference in the quality of life improvement the last decade has brought everyone.

[voakbasda]

IANAL, but they may not be ignoring those laws; they may be planning to fight them. That cannot happen without standing, which may be easiest to obtain by trying to move forward with this plan.

I suspect they would be breaking federal laws, so I believe consideration of the State's 10th Amendment rights applies here. That would be wonderful and hope that this case brings that topic into the spotlight, because I see 90% of the federal government as being grossly unconstitutional on that basis alone.

Personally, I suspect the market leaders would not want to face the courts, because the exposure would be horrible PR that affects all of their product lines. Moreover, an aggressive and concerted effort to block this effort should be viewed as the anti-competitive behavior of a cartel, which is the status quo de facto that the State is effectively trying to disrupt.

I don't see such a challenge as anything but a lose-lose for those companies. Hopefully, they take the bait and do something stupid that leads to reform at the national level.

[kmeisthax]

We already have precedent for a state outright saying "fuck copyright": Blackbeard's Law[0]. North Carolina copied a photographer's images and then passed a law saying the images were part of the public record and thus not copyrightable. The photographer sued to get the law repealed but SCOTUS decided that sovereign immunity meant there was no standing to overturn the law.

An interesting wrinkle is that Congress already foresaw this and passed a law decades ago waiving state sovereign immunity for patent and copyright claims. But then SCOTUS overturned the patent prong of this federal waiver on the grounds that Congress hadn't proven that states had a pattern of telling patent holders to go fuck themselves. And SCOTUS's reasoning for striking down the suit about Blackbeard's Law was that this also held true for the copyright prong of that law... despite being handed a brazen example of a state nullifying copyright law for their own gain on a silver platter.

What this technically means is that your state could, tomorrow, run their own pirate streaming site and not get sued for it[1]. The only way to stop it legally would be to sue end users, which would be difficult to do for a direct download service[2].

As for antitrust and cartels, since copyright and patents are legal, government-granted monopolies, most courts are very loathe to attack them even when they are used in ways that violate antitrust law. You can see this in FTC v. Qualcomm, where an appeals court smacked down an antitrust ruling for this reason. Compounding this is the fact that a very large contingent of judges have been slowly nullifying antitrust since the 1980s under the "consumer welfare" theory that every tech company is built to maximally exploit.

I could see California getting away with bloodying Eli Lily & Co's nose. But I would not count on this becoming a future model for evading (ab)use of the patent system. Remember, all the states are still part of a federal government that is very much in favor of the patent system as currently constituted, and there are still things they can do to block California.

[0] https://nsglc.olemiss.edu/blog/2020/apr/2/index.html

[1] Assuming your state had not already waived sovereign immunity for copyright

[2] It's commonly believed that you can't sue for downloads, only uploads. This isn't quite true. At least one court has outright said that both are illegal but infringe on different exclusive rights. I don't remember which court.

[outworlder]

> Is California just going to ignore these intellectual property laws? How will the state not be liable for damages when individuals are?

Insulin can be made without breaking patents. Unless you specifically require something branded as Lantus®, for example(which is in no small part due to publications funded by pharmaceutical companies themselves, but also some 'marketing' straight to doctors). There are other longer lasting insulin formulations that can be made.

There are hurdles if you take that route (as described in the article). Many are financial. One is regulatory (biosimilars).

[jjk166]

> But pharma companies are savvy about finding ways to extend their monopolies, with insulin and other drugs, by making minor tweaks to the chemical compound and asking for a patent extension. In the case of insulin, the companies can also modify the delivery device to protect their market share. Each product is meant to be used with specific, company-designed injectors. Though the patents on the artificial insulin developed in the 1990s have started expiring, these companies continue to hold and extend monopolies on either their devices or other chemical compounds, making it harder for generic competitors to enter the market.

> Other federal regulations have added to the challenge. The FDA began to treat insulin as a biologic drug in 2020 — meaning it is made with living materials instead of combining chemicals like conventional pharmaceuticals — which comes with a different set of standards for generic versions, which are known as biosimilars, as well as manufacturing challenges given the precise conditions these products must be made in. Biosimilars can cost up to $250 million to produce and take up to eight years to bring to the market, versus a one-year investment of as little as $1 million for conventional generics. And unless the FDA recognizes a new generic insulin as interchangeable with the products already on the market, health insurers might not want to cover it and doctors may not be willing to prescribe it.

Seems like the barriers for a state entity are exactly the same as the barriers for private generic drug manufacturers, and the state could easily just stop erecting these barriers.

[olliej]

You know developing insulin doesn't require violating patents, right? And the price of insulin in the US is entirely an artifact of monopoly behavior by a small number of pharmaceutical companies?

The ability to mass produce insulin at negligible cost has been around for decades, they guy who discovered it made it patent free even.

Only in the US do companies get away with this kind of price gouging, and only because of monopolistic (or I get oligopolistic?) behavior and BS legal threats against anyone that might impact their profiteering off the work of others (paying off competitors not to compete, and BS patents on minor changes, with applications carefully scattered to maximize length of coverage).

The only reason it's taking someone the size of CA to actually do something, is because the Pharma companies buy out, pay off, or lawyer into oblivion anyone else. All strategies that normally work because the victims of the (to me) clearly illegal monopoly based actions aren't incurring costs if they stop, whereas the gouging and monopoly tactics cost CA huge amounts annually. The only thing Pharma could do to make it worth CA not doing this would be to stop price gouging, which is of course the only reason CA is doing this.

That price gouging is illegal if it's some dude hoarding toilet paper, but not when it's insulin being sold by multi-billion dollar corporations remains absurd. That people come to defend the "IP rights" of these organizations and their BS patents is a really American phenomenon.

[basch]

Insulin is cheap.

Long acting insulin is not.

They are different products, and the formers patent being free has nothing to do with the later innovations being locked down.

[olliej]

The whole point of this is that insulin is more expensive in the US than elsewhere. So maybe it isn't "cheap", the point is the price is being inflated due to many factors, including through monopoly tactics such as paying off competitors to not compete.

[basch]

Traditional insulin is cheap in the US. The price has not changed in a decade. Nobody wants it, it is a product of last resort.

Modern insulin is protected by moats, two of which are intellectual property and regulatory approval. Modern insulin being cheaper in other countries is because they are not following the same trade and approval laws. The way to match abroad prices would be to change protections and approvals, the latter of which is and has been happening over the last five years.

[olliej]

You are missing the point. Every kind of insulin is more expensive in the US than _every_ other country. It's not just old stuff is "cheap", new stuff is expensive. It's old stuff is more expensive in the US, new stuff is more expensive in the US.

Average prices per "standard unit"

  * Rapid acting: $120 (US) vs $13.50 (JP)

  * Rapid-int (?) acting: $107(US) vs. $13 (JP)

  * Short-acting: $87 (US) vs $19 (FR)

  * Short-int acting: $95 (US) vs $13 (JP)

  * Intermediate acting: $73 (US) vs $13 (JP)

  * Long acting: $88 (US) vs $15 (JP)

Based on https://www.rand.org/pubs/research_reports/RRA788-1.html

[basch]

Novolin/ReliOn is nowhere near that expensive. I skimmed it, but report you are citing appears to be averaging the price of insulin types. So if there is a cheap rapid and an expensive rapid, it ignores that somebody can buy the cheap one. That averaging distorts the price of available traditional insulin dramatically.

https://www.goodrx.com/healthcare-access/research/how-much-d...

It is more expensive in the United States because the US is subsidizing the earnings requirements the companies who make the drug require to develop new variants. At a high level, everybody pays insurance, it gets funneled into high drug prices, high drug prices pay shareholders and fund R&D. It's capitalisms version of socialized drug creation, and the rest of the world benefits from the US overpaying.

[zaroth]

Even the modern rapid acting insulin that doctors are prescribing (Humalog, Basaglar, etc.) can be very expensive.

CVS filled a month supply for me after my insurance number had changed and when I went to pick it up they kindly asked for $1300 before I gave them the new insurance info.

[basch]

Rapid (minutes) being modern insulin. Short acting (takes 30 minutes) being traditional insulin. Rapid for the most part being an additional technology and convenience over short acting traditional.

But yes, I didn't leave a complete comment.

[ProjectInsulin]

Hi even the long acting insulin has been quoted to cost around $10 to manufacture (at scale)!

[Rebelgecko]

Will California's insulin be any different than the kind you can get for $25 at Walmart?

[ak217]

Nothing weird about that, it's the essence of federalism. The resilience of the American system of government is attributable in large part to federalism, the marketplace of ideas from the states competing with each other.

There is no patent on insulin, just regulatory capture on which proprietary analogs are approved for medical use. In 2020 the FDA changed the regulatory status of insulin, signaling that it's not going to let that regulatory capture continue. But if it does, there will be a lawsuit, it will go to the Supreme Court, and the pharma companies' arguments will probably get thrown out.

[HDThoreaun]

Insulin is off patent. There are new versions that offer a variety of benefits under patent, but just generic insulin can be made by anyone who passes the governments regulations. Walmart is known for offering generic insulin at lower prices.

[coredog64]

Walmart presumably has a bulk sales deal with Novo Nordisk. The latter actually produces the “ReliOn” brand sold at Walmart.

[gamblor956]

Insulin pricing isn't entirely IP issue; it's been out of protection and available as a generic for many decades now.

The issue is that while insulin is actually quite cheap to make once you get started, the startup-costs associated with getting to that point are quite hefty: lab real estate, equipment to make and purify, FDA fees, etc.

Newer versions of insulin are "better" than generic insulin: easier to take, fewer side effects, etc. The major insulin producers have been slowly doling out minor improvements over time, about every decade or so, to maintain IP protection on these newer modern versions of insulin, and the high prices associated with these newer versions. They've also been paying off several generics manufacturers to delay them from manufacturing generic versions of these modern versions as the patents expire.

[outworlder]

> Newer versions of insulin are "better" than generic insulin: easier to take, fewer side effects, etc.

Even that is debatable. At least Sanofi has been known to fund some rosy articles about their Lantus® product. When the EU looked into it (for similar initiatives) they were not able to find the large 'performance' gap that was suggested between that insulin and alternatives.

[davikr]

As far as I know, the major difference between insulin types is not their performance, but how long they take to act, when they peak and for how long they have an effect. Some types of insulin, like glargine (as in Lantus®) can be more convenient due to their long-acting response that lasts for an entire day.

I suppose off-patent insulin could be produced with some degree of inconvenience to the consumer because they might have to take more doses per day, but they should work nonetheless.

[basch]

Long acting insulin is exactly what this entire debate has always been about. Generic standard insulin has been cheap at walmart forever. They even sell cheap rapid acting ReliOn.

People want long acting insulin cheap. (short-, intermediate-, rapid-, and long-acting, ultra-long-acting (42h) insulin are the main categories.) Long acting insulin was the product that had a price jump at the end of 2017.

I am pretty sympathetic to the non long acting stuff not being good enough. Expecting people to monitor hour after hour, and only calling it an inconvenience really downplays how tedious it is to stay alive.

[zaroth]

T1D patients use both types if they are self-injecting. The long acting covers your basal rate (baseline) and the fast acting covers carbs you eat.

Or if you have a pod or pump then you can use only the rapid acting and the software will drip it slowly to cover your basal need over the 24h.

Trying to use just the fast acting with self-injections doesn’t work because you go high overnight while you’re sleeping, and even during the day you would have to be injecting every 3 hours to keep up. (E.g. when your pump controller dies on vacation and all you have on hand is rapid-acting)

Source: I have two kids with T1D.

[basch]

Which would be covered by traditional mixed, short and intermediate insulin, right? The price of Novolin 70/30 (mixed), Novolin R (rapid) and Novolin N (intermediate) insulin have remained flat since 2014. (Short acting and Rapid are two different things, the former being the old kind of insulin that takes 30 minutes, the latter being modern tech that takes minutes.)

It's when you want something better, that lasts longer than Novolin N that price starts to go up. (Novolin N is typically injected underneath the skin (subcutaneously) once or twice per day.)

Obviously, if you have insurance, I would expect you to be being prescribed something better, because that's how the world works. Then you can jump from traditional insulin to rapid and long lasting, and pens.

[cma]

> They've also been paying off several generics manufacturers to delay them from manufacturing generic versions of these modern versions as the patents expire.

Isn't that already illegal (price fixing/collusion)? How are they structuring the deals to avoid prosecution?

[fallingfrog]

The inventor of insulin sold the patent in 1923 to the University of Toronto for one dollar so that nobody could take advantage of people in the way that's currently being done.

This is 100 year old technology. It has nothing to do with development cost.

https://www.vox.com/2019/4/3/18293950/why-is-insulin-so-expe...

[coredog64]

There’s not a single word in that entire article that calls out that modern insulin products are not the same animal-derived insulin that was isolated 100 years ago.

[PragmaticPulp]

> I feel like I'm missing something here. My understanding of why insulin is so expensive: laws are created and enforced by the government preventing people from competing in the space

The article doesn't do a good job of explaining that "insulin" isn't a single drug, or at least how they describe it.

Generic insulin is cheap. You can get it for $25/vial from your local Walmart. With production costs, regulation compliance, storage, transport, and paying pharmacists, they're not making much profit on that.

Patented insulin analogs are not cheap. They have different characteristics for duration and onset time that make them easier to dose, but the patent means that you can't produce and sell it unless you own the patent or have licensed it. Drug companies who own these patents set their prices according to what they can get insurers to pay, not according to what they expect people to pay out of pocket.

One of the weird quirks of the US medical system is that drug companies often have alternate prices for people without insurance. Remember, the high prices aren't designed for you to pay, the high prices are designed to extract as much money as possible from your insurance company.

You can see this in action on drug company websites. Lilly has a program that will cap your payments at $35 for even their expensive insulin analogs: https://www.insulinaffordability.com/ You have to renew every 12 months and hope they're still doing it, but they generally keep these programs around because it dampens the outrage about the high prices.

[skeletal88]

If it was about intellectual property then it would not be tens of times cheaper in the EU and other countries. Insulin is not something new and advanced that needs special protection

[CodeWriter23]

What you’re missing here, just like how everything runs in California (and perhaps in most places), the government won’t be in the business of manufacturing insulin. They will choose a winner to be the subcontractor to produce the product. That firm will meet a price point for the duration of the contract and then renegotiate. Or go into the market like the other players.

[refurb]

Its ridiculous initiative is why.

California will make insulins already off patent. Ones where lower cost versions are already available. It would be far smarter to just subsidize existing versions.

But it doesnt solve the problem that the latest cutting edge patented insulins cant be copied by the government.

[roenxi]

Not knowing anything about the specifics of California, but bad law here seems to follow a rough process:

1. Centralise power in a regulatory body that will raise costs every time something goes wrong.

2. The barrier to getting things done rises until there is a crisis.

3. The barrier is so high only someone behaving like a financial illiterate would enter the market, so legislators task government with entering the market or underwriting someone who can.

So I'd assume that legal ability that was ever the problem. Usually it is regulatory requirements implying a minimum size of the actor needed to take on the risk. I see a few comments that this time around the technical term implementing this for insulin is "bioequivalence" but the broader pattern applies in a few markets and should be called out.

[blendergeek]

> Is California just going to ignore these laws? How will the state not be liable for damages when individuals are?

IANAL. But would this be similar to Jim Olive Photography v. University of Houston System?

https://fairuse.stanford.edu/case/jim-olive-photography-v-un...

[m3kw9]

It’s only the modified versions that are protected and still only for 10 years, so the govt can choose a mod that has its patent expired

[standardUser]

>> Is California just going to ignore these intellectual property laws?

Like they ignored asinine federal drugs laws? I hope so!

[lotsofpulp]

California is not ignoring federal drug laws. California has no mandate to enforce federal drug laws.

Rather, the executive branch of the federal government is choosing to not enforce federal drug laws (in some situations, for some drugs).

Federal agents can walk in and charge everyone in a cannabis store anytime they want, as I understand it.

[vippy]

nah, that's some goofy libertarian take. easier to blame the government than monopolistic behavior by pharma corporations and private actors.