The Median Cost of Bringing a Drug to Market is...

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kaboy42

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$985 million. :ohmy:

https://www.biospace.com/article/median-cost-of-bringing-a-new-drug-to-market-985-million/

The Median Cost of Bringing a Drug to Market is $985 Million, According to New Study

Published: Mar 04, 2020 By Mark Terry



One of the arguments biopharma companies make for the high cost of new drugs is the expense of drug development. A new study published in JAMA Network, “Changes in List Prices, Net Prices, and Discounts for Branded Drugs in the U.S., 2007-2018,” provides some concrete data to the argument.

The key question is, how much do drug companies spend on R&D to bring a new drug to market?

The study notes that estimates have ranged from $314 million to $2.8 billion. The authors were Olivier Wouters, an assistant professor of Health Policy at the London School of Economics and Political Science, Martin McKee, professor of European Public Health at the London School of Hygiene & Tropical Medicine, and Jeroen Luyten an associate professor of the Faculty of Medicine at the Department of Public Health and Primary Care with the Leuben Institute for Healthcare Policy.

The research included 63 of 355 new therapeutic drugs and biologics approved by the U.S. Food and Drug Administration (FDA) between 2009 and 2018. They note that data was mainly found for smaller companies, products in specific therapeutic areas, orphan drugs, first-in-class drugs, and drugs that received accelerated approval. The data came from 47 different companies.

They found that the estimated median capitalized research and development cost per therapeutic product was $985 million.

The authors wrote, “After accounting for the costs of failed trials, the median capitalized research and development investment to bring a new drug to market was estimated at $985 million (95% CI, $638.6 million - $1228.9 million), and the mean investment was estimated at $1335.9 million (95% CI, $1042.5 million - $1637 million) in the base case analysis.”

The median estimates for therapeutic areas that had five or more drugs ranged from $765.9 million for nervous system therapeutics to $2.7716 billion for cancer and immunomodulating drugs.

The authors note that the primary difference for their study from others available is they relied on publicly available data.
A study published by the Tufts Center for the Study of Drug Development published in the Journal of Health Economics in May 2019, gave an estimated cost of $2.6 billion. That study broke down the number to include approximate average out-of-pocket costs of $1.4 billion and time costs of $1.2 billion.

The Tufts study evaluated the R&D costs of 106 randomly chosen new drugs from a survey of 10 pharmaceutical companies. The drugs were approved from 1995 to 2007. They then calculated the average pre-tax cost of new drug and biologics development. They also included the costs related to abandoned trials and development. They also found that adding an estimate of post-approval R&D costs increased the cost estimate to $2.870 billion in 2013 dollars.
The post-approval studies included studies to test for new indications, new formulations, new dosage strength and regimens, and long-term safety monitoring.

“Drug development remains a costly undertaking despite ongoing efforts across the full spectrum of pharmaceutical and biotech companies to rein in growing R&D costs,” said Joseph A. DiMasi, director of economic analysis at Tufts CSDD and principal investigator of the study “Because the R&D process is marked by substantial technical risks, with expenditures incurred for many development projects that fail to result in a marketed product, our estimate links the costs of unsuccessful projects to those that are successful in obtaining marketing approval from regulatory authorities.”
 

steross

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It may be expensive, but it certainly appears to be hurting the consumer, not the company. Revenue and profits are growing faster than R&D expense:

We looked into changes in the drug industry and found that pharmaceutical and biotechnology sales revenue increased from $534 billion to $775 billion between 2006 and 2015. Additionally, 67% of drug companies increased their annual profit margins during the same period—with margins up to 20 percent for some companies in certain years. Drug industry spending for research and development increased from $82 billion in 2008 to $89 billion in 2014.

https://www.gao.gov/products/GAO-18-40
 
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It may be expensive, but it certainly appears to be hurting the consumer, not the company. Revenue and profits are growing faster than R&D expense:

We looked into changes in the drug industry and found that pharmaceutical and biotechnology sales revenue increased from $534 billion to $775 billion between 2006 and 2015. Additionally, 67% of drug companies increased their annual profit margins during the same period—with margins up to 20 percent for some companies in certain years. Drug industry spending for research and development increased from $82 billion in 2008 to $89 billion in 2014.

https://www.gao.gov/products/GAO-18-40
Hmmm. On the other hand, a pharma that’s not profitable doesn’t attract investors, and thus doesn’t develop (as many) new drugs, and thus might have to charge more for the drugs they do make, or just shut the doors.

It’s not as simple as “just charge less” and expect to get the same existing products with continued development of new products. For example, if an investor can get a 10% return elsewhere, why settle for a max 6% return (because of government price controls) from pharma?

Yes, I think drug prices are too high. But be careful, don’t shoot the goose that lays the golden egg.


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steross

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Hmmm. On the other hand, a pharma that’s not profitable doesn’t attract investors, and thus doesn’t develop (as many) new drugs, and thus might have to charge more for the drugs they do make, or just shut the doors.

It’s not as simple as “just charge less” and expect to get the same existing products with continued development of new products. For example, if an investor can get a 10% return elsewhere, why settle for a max 6% return (because of government price controls) from pharma?

Yes, I think drug prices are too high. But be careful, don’t shoot the goose that lays the golden egg.


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There are plenty of industries with lower profit margins that attract investors just fine. Of course, they have lower profit margins because they actually have their products purchased by the consumer not through PBMs and third-party payment that distorts the system with legalized kickbacks.

We are clearly dependent on energy and yet the energy sector is able to provide products, research and develop, and have profits at far lower profit margins. Nobody seems too concerned about the lack of investor interest in that critical sector.

I just get tired of hearing about how expensive it is to produce their product then when you look at the increase in R&D (tiny) vs increase in profit (huge) the truth comes out.

I'm not in favor of government price controls. But, if (and probably when) they happen, the industry has nobody to blame but themselves.
 
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#5
Hmmm. On the other hand, a pharma that’s not profitable doesn’t attract investors, and thus doesn’t develop (as many) new drugs, and thus might have to charge more for the drugs they do make, or just shut the doors.

It’s not as simple as “just charge less” and expect to get the same existing products with continued development of new products. For example, if an investor can get a 10% return elsewhere, why settle for a max 6% return (because of government price controls) from pharma?

Yes, I think drug prices are too high. But be careful, don’t shoot the goose that lays the golden egg.


Sent from my iPhone using Tapatalk
There are plenty of industries with lower profit margins that attract investors just fine. Of course, they have lower profit margins because they actually have their products purchased by the consumer not through PBMs and third-party payment that distorts the system with legalized kickbacks.

We are clearly dependent on energy and yet the energy sector is able to provide products, research and develop, and have profits at far lower profit margins. Nobody seems too concerned about the lack of investor interest in that critical sector.

I just get tired of hearing about how expensive it is to produce their product then when you look at the increase in R&D (tiny) vs increase in profit (huge) the truth comes out.

I'm not in favor of government price controls. But, if (and probably when) they happen, the industry has nobody to blame but themselves.
Your first mistake is to equate profit margins to returns. Your second mistake, it would seem, is to compare revenues to R&D costs. It’s impossible to take one, or two, or three years (etc) of financial performance by a pharma (or an oil & gas company) as a gauge to what their long term returns are. Only a small portion (which can vary wildly year to year) of their capitalized R&D costs (drilling and other capital expenditures for oil & gas companies) are included in the calculation of profits, and therefore gross margin.

Both pharma and oil & gas industries are on the riskier side of the investing spectrum, and thus demand higher returns.

I think you’re playing in the wrong sandbox.


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kaboy42

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May 2, 2007
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#6
It may be expensive, but it certainly appears to be hurting the consumer, not the company. Revenue and profits are growing faster than R&D expense:

We looked into changes in the drug industry and found that pharmaceutical and biotechnology sales revenue increased from $534 billion to $775 billion between 2006 and 2015. Additionally, 67% of drug companies increased their annual profit margins during the same period—with margins up to 20 percent for some companies in certain years. Drug industry spending for research and development increased from $82 billion in 2008 to $89 billion in 2014.

https://www.gao.gov/products/GAO-18-40
Don't disagree with anything you said here sir. BUT, do want to point out something you may have not thought of...

The small biotech company I work for EASILY made up the 20% profit margin just from technology alone. In 2006 we did all production in stainless steel equipment and product contact flow paths. This "old school" tech means hours and hours and hours of cleaning and verification and EXTREMELY COSTLY cleaning validations... for every.single.product.

Today in 2020, we do the same processes in almost 100% disposable flow paths now. Which means little to no cleaning and no costly validations. We don't have to charge more for the products we make, because the newer tech is allowing us to do it for cheaper.



And yeah, I started this thread because I hear it ALL.THE.TIME: "Big pharma is raping the consumer. Every single drug company. There is ZERO reason my prescription should cost $80/month." :rolleyes:

*Yeah, even I've had a prescription that cost me ~$300 for a months supply. But I also know how much cost went in to developing it. AND how many govt hoops and red tape had to be jumped to get market approval.
 
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#7
What about the injection my wife takes once a month. In five years, it has increased about 500%. I'm curious what the justification would be for that? Same drug, same injector.
 
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#8
What about the injection my wife takes once a month. In five years, it has increased about 500%. I'm curious what the justification would be for that? Same drug, same injector.
The simple answer is: the increase in price is to allow the maker to stay profitable and thus stay in business. Unfortunate, but a reality.


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NotOnTV

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As a brand name pharma product approaches the patent cliff, the price for it rises before the generics/biosimilars start hitting the market.
 

Donnyboy

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Hooooooray govt healthcare!!!!! Thank you for protecting us from things the world has access to at the tune of billions of dollars annually
 

steross

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Your first mistake is to equate profit margins to returns. Your second mistake, it would seem, is to compare revenues to R&D costs. It’s impossible to take one, or two, or three years (etc) of financial performance by a pharma (or an oil & gas company) as a gauge to what their long term returns are. Only a small portion (which can vary wildly year to year) of their capitalized R&D costs (drilling and other capital expenditures for oil & gas companies) are included in the calculation of profits, and therefore gross margin.

Both pharma and oil & gas industries are on the riskier side of the investing spectrum, and thus demand higher returns.

I think you’re playing in the wrong sandbox.


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LOL.

Comparing is not equating. You are the one that brought returns into the conversation, not me.

I’m not the one who has pointed out this issue, many have including the GAO. If you think that you have cornered the market on economic thought, maybe you should let them know. They compared many years, not a few.

And blindly defending a sandbox despite all evidence doesn’t make your claim any stronger. This is the typical convo with you, I bring data, you resort to authority fallacy and attempts to wow people with vaguely alluding to fundamental valuation ideas as if your opinion is fact.

You can have your opinion that the methods that this industry uses to get paid are on the up and up but even a causal look at the lack of transparency shows that it isn’t true. And, at some point they will reap what they sow, even if we both agree that price controls as a method to fix it are not the best idea.
 

steross

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What about the injection my wife takes once a month. In five years, it has increased about 500%. I'm curious what the justification would be
Here is the non-simple answer:
Step one is the fact that you aren't the customer. Your insurance company is.
Second, in an effort to stem the high cost of drug, PBMs were created. They were a middleman to create formularies, negotiate prices etc.
But, now, PBMs get a cut (called rebates or fees but really are kickbacks). With insurance companies being required to spend 80% of the premium on health care by ACA rules, often it isn't really in their interest to get lower prices anymore because 20% of a bigger number is better if they can do it. So, the system frequently does not really function the way it was supposed to be designed.
 

UrbanCowboy1

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#13
The simple answer is: the increase in price is to allow the maker to stay profitable and thus stay in business. Unfortunate, but a reality.


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It is unfortunate. But the simple truth to your simple answer is people will only put up with that for so long. You can't keep increasing prices forever: people will reach a breaking point. You could argue we're already there based on the lefts talking points.
 
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#14
Your first mistake is to equate profit margins to returns. Your second mistake, it would seem, is to compare revenues to R&D costs. It’s impossible to take one, or two, or three years (etc) of financial performance by a pharma (or an oil & gas company) as a gauge to what their long term returns are. Only a small portion (which can vary wildly year to year) of their capitalized R&D costs (drilling and other capital expenditures for oil & gas companies) are included in the calculation of profits, and therefore gross margin.

Both pharma and oil & gas industries are on the riskier side of the investing spectrum, and thus demand higher returns.

I think you’re playing in the wrong sandbox.


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LOL.

Comparing is not equating. You are the one that brought returns into the conversation, not me.

I’m not the one who has pointed out this issue, many have including the GAO. If you think that you have cornered the market on economic thought, maybe you should let them know. They compared many years, not a few.

And blindly defending a sandbox despite all evidence doesn’t make your claim any stronger. This is the typical convo with you, I bring data, you resort to authority fallacy and attempts to wow people with vaguely alluding to fundamental valuation ideas as if your opinion is fact.

You can have your opinion that the methods that this industry uses to get paid are on the up and up but even a causal look at the lack of transparency shows that it isn’t true. And, at some point they will reap what they sow, even if we both agree that price controls as a method to fix it are not the best idea.
Clearly you DO NOT understand. Returns are what real investors target. Profit margins are what rookie wannabes look at.

Example:
A start up pharma co spends $1b over ten years to bring their first product to market. In year 11 they sell their first product with targeted sales of $550 million per year designed to yield a 10% cash on cash return over the 10 year life of the patent.
Gross margin for the first 10 years is 0.
If total non-R&D expenses are $200million per year, and amortized R&D are $100 million per year, net income for years 11-20 are $250 million per year or a gross margin of 45% of sales.
Total income over 10 years will be $2.5 billion on a $1 billion investment, but the cash on cash internal rate of return is 10% - the real measure of an investment.
But I’d guess you’d look at the 45% gross margin and say the company is or will be making too much money - and that is the problem. Politicians either lie and use your ignorance to get what they want, or they don’t understand themselves and use your and their ignorance to get what they want - your vote.


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steross

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Don't disagree with anything you said here sir. BUT, do want to point out something you may have not thought of...

The small biotech company I work for EASILY made up the 20% profit margin just from technology alone. In 2006 we did all production in stainless steel equipment and product contact flow paths. This "old school" tech means hours and hours and hours of cleaning and verification and EXTREMELY COSTLY cleaning validations... for every.single.product.

Today in 2020, we do the same processes in almost 100% disposable flow paths now. Which means little to no cleaning and no costly validations. We don't have to charge more for the products we make, because the newer tech is allowing us to do it for cheaper.



And yeah, I started this thread because I hear it ALL.THE.TIME: "Big pharma is raping the consumer. Every single drug company. There is ZERO reason my prescription should cost $80/month." :rolleyes:

*Yeah, even I've had a prescription that cost me ~$300 for a months supply. But I also know how much cost went in to developing it. AND how many govt hoops and red tape had to be jumped to get market approval.
I know I am now considered the resident "socialist" now but I completely get it. Apple runs >20% profit margins also. And, you know, everyone loves their products and is willing to spend that. Good for them.

If a company like yours expands or improves something significantly then, yea, absolutely they should be rewarded. But, much of what is coming out now is unfortunately overpriced garbage that is only an "improvement" based on massaged data. The only reason that people get it is because it is on formulary. And, it is on formulary because some PBM made a deal and lobbied like crazy. It is just a bad consumer model. My point was not to be Bernie and say that the government should say what the stuff will cost. My point is that we aren't having a capitalism v socialism discussion. We are having a "why is this particular industry model so whack" discussion. But, some seem to think that any point that isn't "all that is even called capitalism is wonderful" needs to be defended against.

I would hate for good innovative companies to get hurt by the issues of the system as a whole. But, that appears to be the direction because at the point people say enough is enough as @UrbanCowboy1 pointed out, stupid decisions can occur.
 

steross

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#16
Clearly you DO NOT understand. Returns are what real investors target. Profit margins are what rookie wannabes look at.

Example:
A start up pharma co spends $1b over ten years to bring their first product to market. In year 11 they sell their first product with targeted sales of $550 million per year designed to yield a 10% cash on cash return over the 10 year life of the patent.
Gross margin for the first 10 years is 0.
If total non-R&D expenses are $200million per year, and amortized R&D are $100 million per year, net income for years 11-20 are $250 million per year or a gross margin of 45% of sales.
Total income over 10 years will be $2.5 billion on a $1 billion investment, but the cash on cash internal rate of return is 10% - the real measure of an investment.
But I’d guess you’d look at the 45% gross margin and say the company is making too much money - and that is the problem. Politicians either lie and use your ignorance to get what they want, or they don’t understand themselves and use your and their ignorance to get what they want - your vote.


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And your problem is that you think ONLY in terms of how you invest. There is a far bigger picture here that you are missing. The GAO evaluated an industry over decades, not one start up that you are looking at on your Interactive Brokers account. You picked one point, profit margin to harp on while ignoring the rest of it because it shows that R&D is growing at a tiny rate . You are comparing an orange to an apple orchard with this tunnel vision example. When someone makes dodgy points while calling me ignorant then I know I am winning. There is no such thing as making too much money if the money is being made in an appropriate way. But, if it appears we are being fleeced by poor policy supplementing an underperforming industry, then that needs to be looked at.

The hilarious part is that all you "capitalists" are claiming that we should continue to pay insane prices through "insurance" (which now is really socialist collective payment since the insurance company negotiates, not you ). And, furthermore, justify it by saying that we should continue it to keep the companies in business because the rest of the world does not pay them enough. Gee, maybe if China were to limit how much people will pay for a Tesla from the new Chinese Tesla factory we should all chip in and pay $350000 for them to keep the company going.

If despite charging so much money that nearly all of the the actual consumers cannot pay and instead has to get the government (around 50%) or employer subsidized insurance to pay it that is an industry with a problem. Their R&D is nearly static, their revenues are increasing, their profit margin is persistently high, and their rate of return stinks, hmmm, sounds like an industry we should just keep throwing money at instead of trying to figure out what the problem is.
 
Sep 29, 2011
982
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#17
Clearly you DO NOT understand. Returns are what real investors target. Profit margins are what rookie wannabes look at.

Example:
A start up pharma co spends $1b over ten years to bring their first product to market. In year 11 they sell their first product with targeted sales of $550 million per year designed to yield a 10% cash on cash return over the 10 year life of the patent.
Gross margin for the first 10 years is 0.
If total non-R&D expenses are $200million per year, and amortized R&D are $100 million per year, net income for years 11-20 are $250 million per year or a gross margin of 45% of sales.
Total income over 10 years will be $2.5 billion on a $1 billion investment, but the cash on cash internal rate of return is 10% - the real measure of an investment.
But I’d guess you’d look at the 45% gross margin and say the company is making too much money - and that is the problem. Politicians either lie and use your ignorance to get what they want, or they don’t understand themselves and use your and their ignorance to get what they want - your vote.


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And your problem is that you think ONLY in terms of how you invest. There is a far bigger picture here that you are missing. The GAO evaluated an industry over decades, not one start up that you are looking at on your Interactive Brokers account. You picked one point, profit margin to harp on while ignoring the rest of it because it shows that R&D is growing at a tiny rate . You are comparing an orange to an apple orchard with this tunnel vision example. When someone makes dodgy points while calling me ignorant then I know I am winning. There is no such thing as making too much money if the money is being made in an appropriate way. But, if it appears we are being fleeced by poor policy supplementing an underperforming industry, then that needs to be looked at.

The hilarious part is that all you "capitalists" are claiming that we should continue to pay insane prices through "insurance" (which now is really socialist collective payment since the insurance company negotiates, not you ). And, furthermore, justify it by saying that we should continue it to keep the companies in business because the rest of the world does not pay them enough. Gee, maybe if China were to limit how much people will pay for a Tesla from the new Chinese Tesla factory we should all chip in and pay $350000 for them to keep the company going.

If despite charging so much money that nearly all of the the actual consumers cannot pay and instead has to get the government (around 50%) or employer subsidized insurance to pay it that is an industry with a problem. Their R&D is nearly static, their revenues are increasing, their profit margin is persistently high, and their rate of return stinks, hmmm, sounds like an industry we should just keep throwing money at instead of trying to figure out what the problem is.
You kinda forget my original point. Investors have to get a reasonable return or guess what, they don’t invest. But you’re gonna make a decision on some idea of gross margin or what the GAO says? Guess what, the GAO might be the last place I’d look for data to base on which to base an investment.

You’re making financial assessments without the requisite financial knowledge base to perform meaningful analysis. It’s comical.

Oh, and your R&D BS is just that, BS.


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steross

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You kinda forget my original point. Investors have to get a reasonable return or guess what, they don’t invest. But you’re gonna make a decision on some idea of gross margin or what the GAO says. Guess what, the GAO might be the last place I’d look for data to base on which to base an investment.


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You framed this as an investment, not me. My point was that the high cost of drugs is not because of increasing R&D costs overall as they aren't really increasing.


Ok, bear with me a sec. Let's pretend that you thought that man-made climate change was a real threat.
And, let's say that China did restrict the cost of a Tesla to $30000 USD which means that Telsa is essentially break-even there and cannot gain money for battery development.

Someone proposes that in the US if your car gets totaled, if you replace it with a Tesla, your insurance company will pay Tesla a price high enough for a model 3 so that Tesla can continue to develop batteries to "save the planet" Tesla and the insurance company's contract negotiation company settle on a price around $200000 for a model 3 with a 10% deductible so the consumer pays $20000 directly and insurance rates adjust to cover this deal.
Good idea so that there is a reasonable rate of return on investment in Tesla?

Because, essentially, that is in a nutshell what is being defended here. Drug prices elsewhere are restricted. We have a convoluted system where a third-party through a middle-man negotiates the prices here and at levels that allow R&D to continue (along with a rate of return) instead of what the consumer actually thinks the product is worth. This isn't really capitalism.
 

UrbanCowboy1

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#19
I know I am now considered the resident "socialist" now but I completely get it. Apple runs >20% profit margins also. And, you know, everyone loves their products and is willing to spend that. Good for them.

If a company like yours expands or improves something significantly then, yea, absolutely they should be rewarded. But, much of what is coming out now is unfortunately overpriced garbage that is only an "improvement" based on massaged data. The only reason that people get it is because it is on formulary. And, it is on formulary because some PBM made a deal and lobbied like crazy. It is just a bad consumer model. My point was not to be Bernie and say that the government should say what the stuff will cost. My point is that we aren't having a capitalism v socialism discussion. We are having a "why is this particular industry model so whack" discussion. But, some seem to think that any point that isn't "all that is even called capitalism is wonderful" needs to be defended against.

I would hate for good innovative companies to get hurt by the issues of the system as a whole. But, that appears to be the direction because at the point people say enough is enough as @UrbanCowboy1 pointed out, stupid decisions can occur.
And I'm a capitalist, haha. I think it's more this particular industry has gone crazy. We've got this weird semi-socialist, semi-independent form of healthcare and it's not doing anyone any favors.
 

NotOnTV

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#20
Say what you want about Bernie, but he's ready and willing to stand with you at that pharmacy counter and argue down that Lipitor co-pay. Che Guevara level stuff there, boyyeeeee!!