Republicans fight against the true enemy - cheap insulin

Author: Ramshutu

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#31
Swagnarok
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@Ramshutu
Whether or not you think it's fair that the cost would be passed down to the average medical consumer, it'd happen regardless. Even the CBO stated as much.


If you want to do something about skyrocketing insulin prices, then support supply-side economics. Lower regulatory barriers so that more companies (heck, it could be a non-profit) can get into the market and mass-produce cheap insulin for varieties and products whose patents have expired. Break the triopoly. The more supply rises and the greater the number of suppliers, the harder it is to keep prices artificially high.

This article lays out some existing barriers: the FDA's reluctance to approve insulin biosimilars (none approved as recently as 2020), lack of legal interchangeability between biosimilar products, and "entry barriers and anticompetitive practices", (admittedly the fault of private companies). Support policies that would reform the FDA and curb efforts by the established giants to block new competitors. But price controls have a terrible historical track record.

#32
IwantRooseveltagain
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@Swagnarok
The CBO didn’t say that at all - this is what the article quoted the CBO saying - 


“Spending for insulin and other pharmaceutical products would increase, CBO estimates, because overall medication use would increase in response to lower cost-sharing requirements,” CBO director Phillip Swagel wrote to Sens. Jeanne Shaheen (D-NH) and Susan Collins (R-ME) on Friday. “Some use of insulin might also shift to newer and more expensive insulin products. Increased spending for pharmaceutical products would result in increased spending for health care overall.”

You should read your articles more carefully and take the time to understand what you are reading.
#33
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@thett3
The WaPo is so funny, “democracy dies in darkness” but all their stuff is paywalled 
Wapo is a threat to Democracy confirmed.
#34
IwantRooseveltagain
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Please explain why insulin costs 10 times as much in this country as it does in other industrialized countries - according to the article you cited from Endpoint News.

“Three drugmakers control the more than $20 billion insulin market — Eli Lilly, Novo Nordisk, and Sanofi — as the current price of insulin in the US is more than 10 times that of 33 other comparable countries, even as the net price of insulin has declined in recent years”.

Do those countries have many many makers of insulin thanks to “lower regulatory barriers” or do they get their insulin from the same three manufacturers the US does?
#35
Greyparrot
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@Swagnarok
Effect on Net Prices

Net prices for insulin would be higher, on average, under the certification
process in the INSULIN Act than under current law, CBO estimates.
Certification would be a voluntary process, and CBO expects that
manufacturers would certify an insulin product if it was financially
advantageous for them to do so. In addition, post-sale rebates would be
prohibited for certified insulin products, which would limit insurers’ ability
to negotiate for lower net prices.
Net prices for certified insulins would also rise because their lower list
prices would reduce the statutory discounts in Medicaid and Medicare

• In Medicaid, net prices—and therefore net spending—for insulin would
increase because the reduction in statutory rebates paid for insulin
would be larger than the reduction in list prices. That would occur
because reductions in list prices tend to reduce both the basic rebate and
the inflation-based component of Medicaid’s statutory rebate amount.
• In Medicare Part D, lower list prices would lead to smaller discounts
paid through the coverage gap discount program. That would occur
because of less overall spending in the coverage gap phase of the
benefit, in which manufacturers are required to pay a discount equal to
70 percent of the price paid at the pharmacy counter. As a result,
manufacturer discounts paid for prescriptions in the coverage gap would
fall, which would further increase net prices in Medicare Part D.

#36
IwantRooseveltagain
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@Greyparrot
Why do you say that?
#37
Greyparrot
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@IwantRooseveltagain
I didn't the CBO report did, you know the report you didn't read all the way through.

#38
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@Greyparrot
I was talking about your comment “WAPO is a threat to Democracy confirmed” whatever that means.

That link to the CBO report was not posted in your comment  about insulin. Did you read it? Where does it say as you claim “the net prices for insulin would be higher, on average, under the certification process in the INSULIN Act than under current law, CBO estimates.” 

CBO says the government would spend more on insulin because more Americans would start using it if it became available at a cost  of $35 a month. They do not say the price of insulin (per dose or per patient ) would increase.

#39
Greyparrot
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Where does it say as you claim “the net prices for insulin would be higher, on average, under the certification process in the INSULIN Act than under current law, CBO estimates.” 
Dude, it's literally cut and pasted from the report. Is English your 2nd language?
#40
3RU7AL
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@Ramshutu
The Brave Republicans showed - again - how they are fighting for the little guy - by voting to strip out a cap on insulin prices in private insurance.


I guess $35/month insulin costs just make those poor people lazy.
exactly
#41
3RU7AL
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@Greyparrot
Canadian insulin is 10 times cheaper than American insulin riddled with government mandates in the name of  "safety"
When inventor Frederick Banting discovered insulin in 1923, he refused to put his name on the patent. He felt it was unethical for a doctor to profit from a discovery that would save lives. Banting’s co-inventors, James Collip and Charles Best, sold the insulin patent to the University of Toronto for a mere $1. They wanted everyone who needed their medication to be able to afford it.

The 3 main reasons cited by pharmaceutical companies for the high cost of new prescription drugs do not apply to insulin. First, the “high cost of development” is not relevant for a drug that is more than 100 years old; [**]
#42
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@IwantRooseveltagain

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#43
Ramshutu
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I swear! that almost seemed like pure satire straight out of the Onion.
That’s 5 deleted posts in a row - at least this time you left it around long enough.

Onion titles such as “conservative blaming insulin prices on over regulation checks watch, states ‘is that the time’ when asked which regulations and how?”

Or maybe “conservative accidentally points to substantially more regulated Canadian pharmaceutical system as example of regulation done right”

Those are better.

Insulin is 100 years old technology - there’s been cheaper insulin sold 10 years ago. The issue is not that it’s now expensive to produce, or even that it’s particularly burdensome for a new company to come along and create a new product (it’s not).

The issue is what incentive does a new company have to come in and set up the manufacture of cheap, low margin insulin; when they face stiff competition from 3 entrenched competitors that will prevent your cheap, low margin insulin from getting to consumers through anti-competitive practices - because that’s what happens in poorly regulated low oversight market capitalism, especially when a variety of rebate and marketing systems exist that provide a structural market advantage to existing companies.

#44
Greyparrot
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@3RU7AL
Lol, the satire on this site is gold.
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#45
Ramshutu
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@Swagnarok
Firstly - the CBO report is about the INSULIN act - not the current reconciliation price cap. So we’re not really talking about the same thing - as the price cap in this bill isn’t what the CBO said is what raises net prices.

Like I said - a Medicare price cap and/or insurance price cap would absolutely increase spending and premiums on insulin - because the little people can now afford to use it; and the cost is either spread out across tax payers (the point of socialized medicine), or across premium payers of insurance (the point of insurance). But that’s not actually a bad thing.


Secondly - the issue is - as you said - the pharma and PBM oligopoly, lack of regulation in marketing, PBMs and business practices which are not particularly regulated or enforced for anti-competitive behaviour. 

After all - it’s not like there are multiple generic insulin brands by competing manufacturers in Canada - and that’s what’s keeping the prices low - they’re provided by the same 3 companies, and near identical safety and pharmaceutical manufacture regulations. Yet Canada doesn’t have the same issue.

If those monopolies at the insurance, PBM and pharmaceutical level are broken up or better regulated to avoid anti-competitive behaviour, or regulated in such a way that key players aren’t driven by market forces due the industry structure to drive up the offered price in order to make sales  - prices will come down.

Regulations relating to how it can be proven that your insulin is safe, works well, and can be prescribed interchangeably with another are all pretty critical factors and are somewhat unique for insulin; it’s probably not a big deal for a pharmaceutical company to develop their own brand of their own insulin, but if it’s safe, effective - but can’t be prescribed interchangeably - that presents a specific market barrier that isn’t fixable by any regulation you wouldn’t really want to remove - and aren’t issues in multiple other countries who have far lower prices due to stronger regulation.



#46
3RU7AL
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@Greyparrot
California to manufacture its own insulin, Newsom says [**]
#47
Greyparrot
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@3RU7AL
Newsom is now my favorite Democrat willing to fight the FDA restrictions on insulin production.
#48
Greyparrot
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@3RU7AL
Its so  hilarious how blindly government sycophants support the idea that we can't have 10x cheaper Canadian "SNAKE OIL" because Canada somehow produces an "UNSAFE " insulin.

That's not just an ostrich burying the head in the sand, that is the entire body 6 feet under ground!
#49
3RU7AL
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@Greyparrot
American Made, Cheaper Abroad: The Conclusion – 76% Savings Abroad!

But so many FDA-approved drugs currently sold in U.S. pharmacies are imported – 40% according to the FDA – and many are generics. As our vice president Gabriel Levitt said, “We looked only at brand name medications manufactured in the U.S., not because they’re any safer than those made elsewhere, but because we found it so compelling that the same drugs made here are about 76% less expensive abroad.” [**]
#50
3RU7AL
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@Ramshutu
Insulin is expensive because of the free market - there’s no onerous regulation: no new or unreasonable huge hurdles or steps that require pharmaceutical companies to spend much more - it’s not regulation causing the issues at all - this would be a lie.
insulin is expensive because of corporate lobbying to restrict competition
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#51
Ramshutu
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@Greyparrot

Newsom is now my favorite Democrat willing to fight the FDA restrictions on insulin production.
But that’s just untrue; and you know it.

There’s not really any restrictions - you certainly can’t name any. You’re just spinning your own tires, and deleting your own posts telling me how there is, instead of explaining which ones.

The safety rules are mostly the same as in Canada - Canada has exactly the same insulin sold, with no generics competitors driving the price down - and has much cheaper prices with strong government regulation. The big barrier is that the human analogues are expensive to design, all the manufacture is covered by trade secrets and have to be developed from scratch, and needs to follow the process of making sure medication doesn’t kill people before it’s sold; and needs to be interchangeably prescribed to take off; and if you can do all that, you need to be able to compete for PBMs, and recoup the development costs.

The problem isn’t lack of competition is causing manufacturers to collude to hike prices - it’s that the companies are not competing on  lowest price - they’re competing on what percentage of the sale price they can rebate to PBMs - who will pick the one that will give them most profit.

The main difference is the US allows markers to set the price on critical medicine, where is in places like Canada - that you’ve talked about multiple times - the government is involved with making sure the different companies are selling at reasonable prices.






#52
Greyparrot
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@3RU7AL
insulin is expensive because of corporate lobbying to restrict competition
100% correct. Did you get a chance to click the FDA info page I linked that shows the FDA restricting competition?
#53
Greyparrot
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@3RU7AL
If you were to try to open up an independent insulin lab in your back yard, it wouldn't be Eli Lilly, Novo Nordisk and Sanofi shutting you down.

It would be the FDA.
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#54
Ramshutu
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insulin is expensive because of corporate lobbying to restrict competition
There’s just as little competition in Canada. There’s been development and approvals of non-similar
Semglee in 2020, and biosimilar versions in 2021 and from Merck - the issue wasn’t that approval is too expensive or prohibitive - the barrier is not regulatory - but issue relates to the competition in PBMs: manufactures have relatively low prices, but compete on market share with how much money they rebate to PBMs - which bloats the price.

So your right, in that it’s a competition issue; where lobbyists fight to not have this market regulated, or broken up, or to allow the government to negotiate minimum prices (like they do in Canada) - but it’s not an FDA regulatory issue.

 
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#55
Ramshutu
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@greyparrot

In short, you can have competition ONLY if the FDA "allows" it.
The FDA for sure doesn’t allow you to compete with insulin with injections Radium, fecal transplants and tinfoil hat therapy.

At some point after a long slew of deaths, and injuries we figured out that it’s best if drugs are safe and effective before along them to be sold in competition.

You know, because corporations can’t really be trusted.

#56
Greyparrot
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@3RU7AL
Exclusivity granted by the FDA  gives pharmaceutical manufacturers a temporary monopoly to incentivize new drug development. If a drug qualifies for an exclusivity grant, the FDA prohibits approval of competitor drugs for the length of the exclusivity grant, which can vary from six months to seven years, depending on the reason for the grant. FDA exclusivity grants provide exclusive marketing rights to a particular company, potentially lengthening the time a drug manufacturer has exclusive access to the market. Exclusivity grants differ from patents, because the FDA grants them (not the Patent and Trademark Office), they protect only marketing rights (whereas patents cover a range of rights), and they must be granted at the time of FDA approval of a NDA or ANDA (whereas patents can be granted at any time during development of a drug).Further, exclusivity grants are not required to run concurrently with the drug’s patent term.

#57
Greyparrot
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@3RU7AL
    Laws Limiting Competition     

Strict regulatory programs, such as the patent system and Food and Drug Administration (FDA), can sometimes promote anticompetitive behavior. For the pharmaceutical industry, these two programs unfortunately facilitate a trade-off – restricting competition to promote other important interests. The FDA limits the pool of potential competitors in order to protect consumers through ensuring drug safety and efficacy, and also to promote new drug innovation and generic competition under the Hatch-Waxman Act. The patent system limits competition in order to promote innovation and public disclosure of new inventions. These regulations significantly restrict pharmaceutical company actions, but they also create potential opportunities for those companies to use these regulations to limit competition.

The FDA primarily oversees the safety and efficacy of pharmaceutical products under the Federal Food, Drug, and Cosmetic Act. In order to get a new brand name drug approved by the FDA, a drug maker must file a New Drug Application (NDA), which requires costly investment in formal testing to prove the safety and effectiveness of the new. After approval of a drug, the FDA regulates the production and distribution of the pharmaceutical product. This FDA approval process creates significant barriers to entry because pharmaceutical companies must front the expenses related to complying with the FDA regulatory scheme before selling pharmaceuticals. Even after receiving FDA approval, if production and marketing is not up to FDA standards, the FDA has the power to slow down production, which also may contribute to high product prices. Any new market entrants must have significant start-up capital and the ability to sustain a long runway on rollout. Each of these factors makes it more difficult for competitors to enter the pharmaceutical market.

#58
Greyparrot
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REMS based delay

Brand name drug companies may also prevent generic drugs from entering the market by abusing the FDA’s Risk Evaluation Mitigation Strategies (REMS) program or by implementing similarly restrictive distribution schemes. Nearly 40 percent of drugs approved by the FDA are subject to the REMS program. The REMS program ensures that drugs with significant side effects are properly used and administered. The FDA has additional regulatory requirements for REMS drugs which come in many forms. Elements to Assure Safe Use (ETASA), for example, is the most restrictive type of REMS and requires patient monitoring and testing, certifications for prescribers and pharmacies, and limitations on which hospitals and specialty certified pharmacies can dispense the drug. Given that the FDA use REMS to place limitations on the distribution of a drug, brand name drug manufacturers have abused REMS programs by using them to limit generic drug manufacturers’ access to brand name drug samples, which are necessary for ANDA approval and market entry.

When a generic drug companies files an ANDA, it must prove that the generic drug is a bioequivalent to (i.e. expected to be the same as) the brand name drug by testing samples of the brand name drug against their generic drug. The FDA requires the two types of bioequivalence testing: in vitro (lab testing) and in vivo (in human testing). REMS gives brand name drug manufacturers an excuse for refusing to give out samples of its drug to generic companies for this testing. Brand name drug companies restrict access by implementing a restrictive distribution system, and only allowing drug to be dispensed by approved hospitals or specially certified pharmacies.

This restraint allows the brand name drug company to refuse to sell its sample to a generic drug company, hindering access. Despite brand name companies claims that FDA policy prevents them from distributing samples, the FDA specifically allows brand name companies to sell samples to generic drug manufacturers.
Even if these access limits are only temporary, such barriers cost generic drug companies time and money. Given that REMS abuse makes it more difficult for some generic drugs to get FDA approval and enter the market, REMS abuse leaves the brand name drug company as the sole supplier of the drug. This allows the brand name drug company to maintain its monopoly profits and high prices, and raises overall prescription drug spending. One study of forty generic drugs that REMS based delay tactics have prevented from coming to market estimates that $5.4 billion in annual savings has been lost from REMS based delay. REMS abuse is particularly concerning and dangerous for generic competition because the act is “not linked to patent protection and can continue indefinitely, even after the expiration of all exclusivities.”


#59
ILikePie5
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@Greyparrot
Womp womp
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#60
Ramshutu
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Exclusivity granted by the FDA  gives pharmaceutical manufacturers…
But Insulin manufactures haven’t been granted exclusivity…. 

Strict regulatory programs, such as the patent system and…
Almost all of the insulin patents have expired, right? It’s been around for 100 years…

If only there were more regulations on patenting that prevented companies exploiting the valid patent system to protect incremental improvements on their products and use marketing to drive older products out of the market - glad you agree more regulation here is necessary.

a drug maker must file a New Drug Application (NDA), which requires costly investment in formal testing to prove the safety and effectiveness of the new.
How dare they ensure new drugs are safe. How very dare they!

This restraint allows the brand name drug company to refuse to sell its sample to a generic drug company, hindering access. Despite brand name companies claims that FDA policy prevents them from distributing samples, the FDA specifically allows brand name companies to sell samples to generic drug manufacturers.
Hmm; the FDA is prohibiting competition by not enforcing a regulation - and forcing companies to se drugs to generic manufactures? 

It’s awesome that you agree with this regulation and believe it should be enforced!

I mean - it would stupid to presume you were suggesting that pharma companies would sell samples to generic drug manufactures if the requirement to so was removed, no?


This is all misleading garbage; that pretty succinctly underpins the key message that we need to regulate these industry’s more tightly.

You know - like Canada - where there is no generic insulin either - and the same companies - selling the same insulin - where insulin is super cheap - because the government more deeply regulates the industry - and negotiates prices - because companies you can’t trust major billion dollar companies not to do things that harm the population for profit.

But hey, who cares about facts when you can just delete your posts, amiright!