FDA slams EpiPen maker(arstechnica.com)
arstechnica.com
FDA slams EpiPen maker
https://arstechnica.com/science/2017/09/fda-slams-epipen-maker-for-doing-nothing-while-hundreds-failed-people-died/
118 comments
Scandals should work in that way so they make the senator unreelectable, instead of making the company invulnerable.
It's as if nobody else wants to sit in that chair!
It's as if nobody else wants to sit in that chair!
It is the senator's child. Assuming no other malfeasance, I see no reason to take it out on anyone who isn't actually responsible.
To be fair, assuming no other malfeasance requires a pretty big leap of faith...
To be fair, assuming no other malfeasance requires a pretty big leap of faith...
See reply by "Cozumel" down the thread...
One only have to unearth a small connection between two entities to drown them both (and take the chair).
What is the scandal that warrants “drowning them both?” That a Senator has a daughter who is a CEO? What else?
>What else?
Maybe the fact her mommy is President of the National Association of State Boards of Education and drafted a law making them mandatory for schools to buy, then her husband lobbied for the law, once it became mandatory for schools to stock them they hiked the price to $500.
Maybe the fact her mommy is President of the National Association of State Boards of Education and drafted a law making them mandatory for schools to buy, then her husband lobbied for the law, once it became mandatory for schools to stock them they hiked the price to $500.
Textbook rent-seeking.
Drain the swamp.
If this is not criminal negligence then I don't know what is. I bet nobody goes to prison for it though. It's funny how individuals can go to prison for rather trivial offences that do not harm others. Yet corporations can get away with what basically equates to manslaughter.
Indeed. Corporations are called fictitious entities for a reason, they don't really exist. Send all the people home, and ask a corporation to turn on a lamp, or sell a widget; it can't. We allow their creation because it creates a great deal of convenience to the humans in the business. However, they're still fictitious and the state has the right to dissolve a corporation in some circumstances. Despite this, we seem to have a culture where corporations are given MORE rights than people. We've literally created imaginary monsters that threaten the life and freedom of real human beings.
I like your lamp test, too bad it wasn't part of the Citizens United ruling that made corporations legally people - people with more money than most individuals who can influence legislation more than most individuals.
Corporations have always been people. If corporations weren’t people, you wouldn’t be able to sue them.
"Rip open the diseased heart of a corporation and what spills out?”
“People.”
(From the second book in the altered carbon series)
“People.”
(From the second book in the altered carbon series)
Very good books, all three of them.
And we haven't even put AI in charge of them yet. Wait until those completely soulless statistics-only driven entities start running them while having more than human rights.
Optimisation algorithms have no hidden agenda and are predictable. Given we agree on the variable they optimise for and can check the source code, what's not to like?
First of all, for any non-trivial real-world problem (like e.g. doing a simplest of tasks while respecting human moral values), we do not, generally, agree on the variable (function, actually) being optimized. Nor can we even define it with sufficient amount of precision. This is the core of what's known as "Friendly AI" problem (also known as "AI control problem").
Secondly, optimization algorithms "have no hidden agenta and are predictable" only insofar as you're able to comprehend their implementation. Which, for anything more trivial than blinking an LED, you're most likely not. This is the core of what's known as "programs have bugs" problem in software engineering, and also of the "bugs are exploitable" and "programs can have hidden backdoors" problems in software security engineering.
Secondly, optimization algorithms "have no hidden agenta and are predictable" only insofar as you're able to comprehend their implementation. Which, for anything more trivial than blinking an LED, you're most likely not. This is the core of what's known as "programs have bugs" problem in software engineering, and also of the "bugs are exploitable" and "programs can have hidden backdoors" problems in software security engineering.
This is probably the most inaccurate statement I've ever read.
Here are just some of the assumptions it is making that are flawed beyond repair:
- Algorithms don't have unexpected behaviour.
- Computer programs operating in real time are predictable
- We can agree on what to optimise for
- Checking the source code is always possible
- Checking the source code allows you to understand a program
Here are just some of the assumptions it is making that are flawed beyond repair:
- Algorithms don't have unexpected behaviour.
- Computer programs operating in real time are predictable
- We can agree on what to optimise for
- Checking the source code is always possible
- Checking the source code allows you to understand a program
All those objections I agree with. Yet, this still sounds better than electing people from time to time on the basis of unverifiable promises, with no control on what is actually done unless you can throw a lot of money in lobbying.
The people setting the parameters may have hidden agendas. Or even not so hidden ones, like "make me rich at anybody's cost".
I think a much more likely cause would be biased data.
If you trained against a dataset of all police stops in my state (CT) to predict which vehicles should be stopped to maximize drug finds you'd include multiple large departments that have been under federal investigation for racial discrimination (and were found guilty).
I don't think the hidden agenda would be intentional, but there would be a hidden agenda.
If you trained against a dataset of all police stops in my state (CT) to predict which vehicles should be stopped to maximize drug finds you'd include multiple large departments that have been under federal investigation for racial discrimination (and were found guilty).
I don't think the hidden agenda would be intentional, but there would be a hidden agenda.
Those givens are far from trivial, and getting them wrong is dangerous. You may as well say "Given we can perfectly predict the market, it's possible to make a lot of money"
> Given we ... can check the source code
That's not a given.
That's not a given.
The algorithm, the problem it is applied to, the variables to consider and to optimize, the variables excluded from consideration, and the dats sources used are all choices made by someone with some agenda. And they don't have to agree with you on their choices.
A cancerous tumor or virus is essentially an organically programmed optimization algorithm. I can think of a few things not to like about them.
We kind of have in small ways. Look at high frequency trading algorithms, you have companies spending millions of dollars to shave off a millisecond of network latency in order to maximize HFT algos. Then we see things like the Flash Crash of 2010...
Seems like a reasonable punishment for such criminal negligence for a corporation would be revocation of the patents protecting their monopoly. A corporation does not deserve a government-sanctioned monopoly if it is negligent in how it uses that monopoly power.
What I don't understand about this situation, is that the EpiPen is not covered by patents. It's been off patent for a long time. Why aren't other companies stepping in and making a competing product? If it's off patent and they can make the same product for cheaper, then the branded EpiPen sales will decline which will force them to lower their price.
There is definitely a market failure here, but it's not clear why.
There is definitely a market failure here, but it's not clear why.
Patent is only the first part of inertia to overcome here. You need insurance companies to agree to refund your alternative. You need to get doctors to prescribe it. You need to get pharmacies to stock it. You need to get patients to want them. Only one of these groups has any incentive to help you.
This is why some countries have enacted laws to help with that.
This is why some countries have enacted laws to help with that.
And, laws that don't force the use of brand name drugs.
https://www.statnews.com/2016/08/25/mylan-antitrust-epipen-s...
https://www.statnews.com/2016/08/25/mylan-antitrust-epipen-s...
The specific mechanism Mylan markets is covered by a patent. Some adjustment to the way the needle cap operates.
Of course that patent doesn't prevent other epinephrine autoinjectors from coming to market (and Adrenaclick is available in the US, including a couple generics).
My take is that the FDA should have some authority to deny market approval for such small improvements if the company refuses to license them to generic manufacturers. The hard part is deciding what constitutes a small improvement.
Of course that patent doesn't prevent other epinephrine autoinjectors from coming to market (and Adrenaclick is available in the US, including a couple generics).
My take is that the FDA should have some authority to deny market approval for such small improvements if the company refuses to license them to generic manufacturers. The hard part is deciding what constitutes a small improvement.
Not the market. The FDA.
If people start to pay attention to the process and the corruption surrounding EpiPen, will it blow the lid off the entire FDA system?
If people start to pay attention to the process and the corruption surrounding EpiPen, will it blow the lid off the entire FDA system?
http://slatestarcodex.com/2016/08/29/reverse-voxsplaining-dr...
"They keep trying, and the FDA keeps refusing to approve them for human use."
"They keep trying, and the FDA keeps refusing to approve them for human use."
> Seems like a reasonable punishment for such criminal negligence for a corporation would be ...
But corporations don't make decisions, those are made by the actual human beings that work for those corporations. Those human beings belong in prison.
But corporations don't make decisions, those are made by the actual human beings that work for those corporations. Those human beings belong in prison.
I would love it if that ever happened to any company. Sadly,
With the price hike story though, the public will push for some heads to fall, and prosecution should have the jury on their side for this. I'm willing to take the bet that someone's going to jail for this.
[deleted]
To the commenters suggesting that the FDA should do more to punish this company, consider another alternative: if the FDA actually did less to begin with (while still investigating and providing information transparency), we'd probably be better off.
Instead of relying on the government to fix the situation with slow legislation (which usually ends up with enough loopholes to be circumvented anyway), we should allow the industry to function as an actual free(ish) market. If that were the case, we would already have dozens of better EpiPen alternatives as a result of the previous shenanigans from these companies. In other industries, when a company's product is clearly defective, inferior or overpriced, they lose market share and are forced to either improve the product or go out of business. But when the government plays the role of (slow, expensive, often corrupt) "gatekeeper", that is what creates these abusive monopolies.
Instead of relying on the government to fix the situation with slow legislation (which usually ends up with enough loopholes to be circumvented anyway), we should allow the industry to function as an actual free(ish) market. If that were the case, we would already have dozens of better EpiPen alternatives as a result of the previous shenanigans from these companies. In other industries, when a company's product is clearly defective, inferior or overpriced, they lose market share and are forced to either improve the product or go out of business. But when the government plays the role of (slow, expensive, often corrupt) "gatekeeper", that is what creates these abusive monopolies.
I remember reading about EpiPen when they did their price hike. The main reason they were able to do it is the FDA had given them (intentionally or not) a de-facto monopoly in the US.
https://mises.org/blog/lack-epipen-competitors-fdas-fault
Of course, we don't want just anyone to be able to package up anything and sell it (unless it's the nutrition industry, for some reason) but at the same time, the EpiPen business isn't good for the country either.
What's funny, is this company did the same thing as Shkreli, but does their CEO get the same treatment?
https://mises.org/blog/lack-epipen-competitors-fdas-fault
Of course, we don't want just anyone to be able to package up anything and sell it (unless it's the nutrition industry, for some reason) but at the same time, the EpiPen business isn't good for the country either.
What's funny, is this company did the same thing as Shkreli, but does their CEO get the same treatment?
What treatment? Nothing happened Shkreli in response to what he did with Daraprim. His criminal trial had nothing to do with it. That's a common misconception thanks to our bottom-feeding media.
His public and constant grilling by the media. You certainly didn't hear endless stories about "Pharma Chick," who is the good senator's daughter.
I'm aware that the "Pharma Bro" was convicted of securities fraud after tripling his investors investments.
I'm aware that the "Pharma Bro" was convicted of securities fraud after tripling his investors investments.
> I'm aware that the "Pharma Bro" was convicted of securities fraud after tripling his investors investments.
"Well you see, your honor, I did try to murder the man. But I failed, and the half hour run he took trying to escape me kick-started a healthy lifestyle that added years to his life. So, I did try to murder him, but in the end everyone benefited."
This post-facto justification is like something out of an SNL skit.
"Well you see, your honor, I did try to murder the man. But I failed, and the half hour run he took trying to escape me kick-started a healthy lifestyle that added years to his life. So, I did try to murder him, but in the end everyone benefited."
This post-facto justification is like something out of an SNL skit.
While I agree with you, the problem is trying a person is at the discretion of the state. I suspect the state was motivated by Shkreli's public reputation when they otherwise wouldn't be as motivated to prosecute if it were someone else of lesser celebrity, particularly since the investment outcome was overwhelmingly positive.
We agree.
Perhaps our point of disagreement is this: I believe that justifying objectively blatant criminality via the "discretion of the state" defense is counter-productive to changing this situation.
Perhaps our point of disagreement is this: I believe that justifying objectively blatant criminality via the "discretion of the state" defense is counter-productive to changing this situation.
False equivalence. Shkreli's intent was never to lose these peoples' money.
Fraud does not necessarily result in loss. Losses do not necessarily result from fraud. The whole point of fraud laws is to outlaw behavior, not outcomes. Ditto "attempted X".
> False equivalence
Fraud != intent to lose people's money was literally the point of my post.
> False equivalence
Fraud != intent to lose people's money was literally the point of my post.
Ah, ok, we're in agreement.
> In other industries, when a company's product is clearly defective, inferior or overpriced, they lose market share and are forced to either improve the product or go out of business.
No, they really aren't. [1][2][3]
[1] https://en.m.wikipedia.org/wiki/United_States_v._Microsoft_C....
[2] https://m.phys.org/news/2005-06-amd-sues-intel-monopoly-abus...
[3] http://money.cnn.com/2015/03/19/technology/google-monopoly-f...
No, they really aren't. [1][2][3]
[1] https://en.m.wikipedia.org/wiki/United_States_v._Microsoft_C....
[2] https://m.phys.org/news/2005-06-amd-sues-intel-monopoly-abus...
[3] http://money.cnn.com/2015/03/19/technology/google-monopoly-f...
In none of those cases did the government actually step in and do anything to break up those "monopolies" (other than perhaps an insignificant "slap on the wrist" in Microsoft's case).
So if the government didn't solve those problems, what did? Answer: innovation and competition from other market players.
So if the government didn't solve those problems, what did? Answer: innovation and competition from other market players.
> Answer: innovation and competition from other market players.
I'm not sure what you're referring to. AMD was on its deathbed a few years ago and Intel still has a near-monopoly on desktop and server CPUs. Google continues to be a monopoly on search and website ads. Microsoft has fallen somewhat, but you could argue that this was only due to pressure from regulators (e.g. browser bundling ban in Europe and when Microsoft was funding Apple to keep the perception of competition alive).
I'm not sure what you're referring to. AMD was on its deathbed a few years ago and Intel still has a near-monopoly on desktop and server CPUs. Google continues to be a monopoly on search and website ads. Microsoft has fallen somewhat, but you could argue that this was only due to pressure from regulators (e.g. browser bundling ban in Europe and when Microsoft was funding Apple to keep the perception of competition alive).
And how exactly are these so-called "near-monopolies" hurting consumers? Last I checked, nobody is forced to use Google for search, and people have a choice between buying Intel or AMD processors.
Just because a company makes better products than other companies, that doesn't make it abusive or detrimental to society (in fact, quite the opposite is true). If Intel's prices were unreasonable, no one would buy their processors and the next best alternative (AMD or otherwise) would steal their market share. Same with Google and Microsoft.
Just because a company makes better products than other companies, that doesn't make it abusive or detrimental to society (in fact, quite the opposite is true). If Intel's prices were unreasonable, no one would buy their processors and the next best alternative (AMD or otherwise) would steal their market share. Same with Google and Microsoft.
Yes and no, industry also has it's fair share of monopolies that gatekeep themselves. If a company becomes big and powerful enough it can write tailored legislation and corrupt the right people so that other competitors have no chance.
In this case I'd say you're probably right because the EpiPen is a very simple product, so you'd find a lot of potential competitors, even some with good enough funding to contend with the current market players. However with more complicated medical devices it's harder and harder to compete, because you need so much upfront research money, that you in fact always get a anti-competitive monopoly or oligopoly.
In this case I'd say you're probably right because the EpiPen is a very simple product, so you'd find a lot of potential competitors, even some with good enough funding to contend with the current market players. However with more complicated medical devices it's harder and harder to compete, because you need so much upfront research money, that you in fact always get a anti-competitive monopoly or oligopoly.
> you need so much upfront research money, that you in fact always get a anti-competitive monopoly or oligopoly
Industries with high R&D costs may be more prone to the formation of natural monopolies, but in most cases that's a better scenario than the coercive monopolies created as a byproduct of government regulation.
It could be argued that the tech industry, as one example, has similarly high R&D costs (at least in certain fields), and Apple, Google, Microsoft, etc. have all been blamed for monopolistic practices, but even then, the tech world operates in a much healthier market environment than the healthcare or pharmaceutical industries.
Personally, I'd feel more confident being treated in a theoretical Apple hospital (heck, I'd even go for the cheaper Android version) than any of our real-world hospitals with shiny government seals of approval (and more inefficiencies than one can imagine) - as long as I can rely on a decent level of transparency in safety/quality/pricing of those options.
Industries with high R&D costs may be more prone to the formation of natural monopolies, but in most cases that's a better scenario than the coercive monopolies created as a byproduct of government regulation.
It could be argued that the tech industry, as one example, has similarly high R&D costs (at least in certain fields), and Apple, Google, Microsoft, etc. have all been blamed for monopolistic practices, but even then, the tech world operates in a much healthier market environment than the healthcare or pharmaceutical industries.
Personally, I'd feel more confident being treated in a theoretical Apple hospital (heck, I'd even go for the cheaper Android version) than any of our real-world hospitals with shiny government seals of approval (and more inefficiencies than one can imagine) - as long as I can rely on a decent level of transparency in safety/quality/pricing of those options.
There are plenty of clearly defective products in a barely regulated health-adjacent industry that don't lose marketshare: the entire supplement industry, including homeopathic and "herbal" remedies. Relying on free markets to regulate themselves depends on rational consumers. But we are not rational.
Its not really a problem for me if people buy homeopathic remedies. It is a problem for me that I can't buy cheap, effective epipen alternatives.
What, exactly, are you suggesting the FDA do less of? Are you suggesting that pharmaceutical companies should be allowed to bring their products straight to the market? Or just that their clinical trials process should be relaxed?
What exactly is preventing another company for creating an EpiPen clone?
Probably payouts from the current manufacturer to stay out of the market. Those payoffs are probably greater than the profit they could make as an off-brand generic.
Requiring financial transparency among all possible parties to regulators and banning collusion like the above would actually be the correct way to ensure the market functions properly.
Requiring financial transparency among all possible parties to regulators and banning collusion like the above would actually be the correct way to ensure the market functions properly.
The FDA. Or at least, the FDA has made it extremely expensive and time-consuming for any competitor who wishes to enter the market.
The argument is that a high bar of safety requirements protects consumers (and I'll admit it does to some degree, however inefficiently), but a free market system is more efficient at producing the results that people actually care about (quality, safety, affordability, etc).
Also, patents - another government-run monopoly-maker that should be eliminated.
The argument is that a high bar of safety requirements protects consumers (and I'll admit it does to some degree, however inefficiently), but a free market system is more efficient at producing the results that people actually care about (quality, safety, affordability, etc).
Also, patents - another government-run monopoly-maker that should be eliminated.
a free market system is more efficient at producing the results that people actually care about (quality, safety, affordability, etc)
You have no evidence to support that view; where are the free markets full of safe, high-quality, low-cost medicines? Nowhere.
Markets are brilliant, but they are not flawless. All of our experience suggests that they need robust, independent regulation to avoid negative outcomes. There is plenty of scope for talking about how time-to-market for drugs can be improved, or other steps that can be taken to reduce regulatory burden where it's causing problems. But this whole 'let the free market sort it out' is the worst kind of high-school libertarianism.
You have no evidence to support that view; where are the free markets full of safe, high-quality, low-cost medicines? Nowhere.
Markets are brilliant, but they are not flawless. All of our experience suggests that they need robust, independent regulation to avoid negative outcomes. There is plenty of scope for talking about how time-to-market for drugs can be improved, or other steps that can be taken to reduce regulatory burden where it's causing problems. But this whole 'let the free market sort it out' is the worst kind of high-school libertarianism.
We haven't had free markets for a very, very long time. Consequently, your claim of free markets unavoidably producing negative outcomes lacks evidence.
I didn't say we don't need any regulation, but I will say that government-imposed regulation isn't needed. A truly free market can and will fill that same need in ways that are much more efficient than any government could hope to do through force.
I didn't say we don't need any regulation, but I will say that government-imposed regulation isn't needed. A truly free market can and will fill that same need in ways that are much more efficient than any government could hope to do through force.
We haven't had free markets for a very, very long time. Consequently, your claim of free markets unavoidably producing negative outcomes lacks evidence.
This is basically a "no true Scotsman" argument. What is a "free market"?
I didn't say we don't need any regulation, but I will say that government-imposed regulation isn't needed.
Non-authority-imposed regulation isn't 'regulation' in any real sense.
A truly free market can and will fill that same need in ways that are much more efficient than any government could hope to do through force.*
All evidence we have seen suggests that an absence of government regulation leads to collusion, anticompetitive practices, races-to-the-bottom, and consumer rights violations. On the other hand, removing regulation can allow more innovative approaches to the market. Point is – it's a case of fine-tuning the balance to make sure that participants in a market have equal power. "Throw is all away and start again" is a seductive and ultimately silly argument.
This is basically a "no true Scotsman" argument. What is a "free market"?
I didn't say we don't need any regulation, but I will say that government-imposed regulation isn't needed.
Non-authority-imposed regulation isn't 'regulation' in any real sense.
A truly free market can and will fill that same need in ways that are much more efficient than any government could hope to do through force.*
All evidence we have seen suggests that an absence of government regulation leads to collusion, anticompetitive practices, races-to-the-bottom, and consumer rights violations. On the other hand, removing regulation can allow more innovative approaches to the market. Point is – it's a case of fine-tuning the balance to make sure that participants in a market have equal power. "Throw is all away and start again" is a seductive and ultimately silly argument.
>Non-authority-imposed regulation isn't 'regulation' in any real sense.
How exactly isn't it "real"? Even in the absence of a truly free market, plenty of industries have developed their own self-regulated quality standards.
Have you ever checked reviews about something before purchasing? Did a government mandate those reviews to be written?
> an absence of government regulation leads to collusion, anticompetitive practices, races-to-the-bottom, and consumer rights violations
Isn't it odd that we see more of those problems in industries with the most regulation? In a free market, collusion is ineffective, since any newcomer can undercut prices, forcing the colluding market players to compete. The same could be said for any other unethical or harmful practices; if consumers care enough about a problem, they'll vote with their dollars for better alternatives.
How exactly isn't it "real"? Even in the absence of a truly free market, plenty of industries have developed their own self-regulated quality standards.
Have you ever checked reviews about something before purchasing? Did a government mandate those reviews to be written?
> an absence of government regulation leads to collusion, anticompetitive practices, races-to-the-bottom, and consumer rights violations
Isn't it odd that we see more of those problems in industries with the most regulation? In a free market, collusion is ineffective, since any newcomer can undercut prices, forcing the colluding market players to compete. The same could be said for any other unethical or harmful practices; if consumers care enough about a problem, they'll vote with their dollars for better alternatives.
"We haven't had free markets for a very, very long time. Consequently, your claim of free markets unavoidably producing negative outcomes lacks evidence."
You could easily replace "free markets" with "communism" and make the same statement.
You could easily replace "free markets" with "communism" and make the same statement.
lol.
FDA is the golden standard for medical testing for around the world (I worked for the FDA and that quote I'll quote one of the employee that stated it). After animal testing there are 4 phases of clinical testing.
You sound like all those libertarians that think free market is gonna some how reduce toxicity and dangerous drug from flooding the market.
That's some crazy pipe dream you got there.
These testing is also base on science and more importantly statistic (survival analysis and such). It is stupid as hell to just ignore it. Statistic is every where in lives and have increase the quality of our life including reliability and quantifying on what is statistic significant or not (random chance).
You are a perfect example of why I'm sick of debating libertarian and just straight up call it out.
Free Market is another excuse for ignorant. Whether it is ignorance of how the FDA and drug works to how the economy work (let's back everythign by the gold standard!).
FDA is the golden standard for medical testing for around the world (I worked for the FDA and that quote I'll quote one of the employee that stated it). After animal testing there are 4 phases of clinical testing.
You sound like all those libertarians that think free market is gonna some how reduce toxicity and dangerous drug from flooding the market.
That's some crazy pipe dream you got there.
These testing is also base on science and more importantly statistic (survival analysis and such). It is stupid as hell to just ignore it. Statistic is every where in lives and have increase the quality of our life including reliability and quantifying on what is statistic significant or not (random chance).
You are a perfect example of why I'm sick of debating libertarian and just straight up call it out.
Free Market is another excuse for ignorant. Whether it is ignorance of how the FDA and drug works to how the economy work (let's back everythign by the gold standard!).
The FDA's approval process is to ensure only safe and effective products make it to the market. This is unquestionably good. The problem is that companies can take advantage of the inherent delays in this process to obtain undue market power, and impose monopoly pricing.
The FDA should not reduce it's standards, but it should recognize that the expensive and drawn-out approval process creates large inefficiencies in that market, and they should at least strive to minimize those effects.
The FDA should not reduce it's standards, but it should recognize that the expensive and drawn-out approval process creates large inefficiencies in that market, and they should at least strive to minimize those effects.
I don't buy the regulatory argument. See my previous answers.
Patents, indeed, are a much more efficient way of keeping a monopoly, that's their whole point after all. But I don't a link with regulations in that case.
Patents, indeed, are a much more efficient way of keeping a monopoly, that's their whole point after all. But I don't a link with regulations in that case.
It takes quite a long time and a significant amount of money to perform the necessary studies and get the FDA approval. The time factor alone makes it difficult for a competitor to react efficiently if the main or sole provider for a drug or device increases prices drastically.
Mylan reportedly also used a few more anti-competitive tactics like contracts with schools that lower the price for them, but prohibit the school from buying any competing products (see e.g. http://www.reuters.com/article/us-mylan-new-york/new-york-to... )
Mylan reportedly also used a few more anti-competitive tactics like contracts with schools that lower the price for them, but prohibit the school from buying any competing products (see e.g. http://www.reuters.com/article/us-mylan-new-york/new-york-to... )
The strict FDA requirements are there to make sure only safe and effective products come onto the market. That's a good thing. What's bad is that some can use this system to their advantage to create artificial monopolies.
If you're the only maker of a drug, and even if it's not covered by any patents, you know it'll still take months or perhaps years for a competitor to get FDA approval and compete with you. You can jack up your prices until competitors go through the approval, and you can signal to the market that you will quickly drop the prices if another competitor comes onto the market. This discourages the competitors from even spending the time and money on FDA approval.
Two possible solution to this: (1) reduce the cost of FDA approval for companies that want to make generic copies; or (2) impose taxes or price caps on FDA products that have no competition and command market power.
This all assumes patents are not involved (as is the case here), but both solutions would reduce the intensive for companies to game a system that is intended to make sure only safe products make it onto the market.
If you're the only maker of a drug, and even if it's not covered by any patents, you know it'll still take months or perhaps years for a competitor to get FDA approval and compete with you. You can jack up your prices until competitors go through the approval, and you can signal to the market that you will quickly drop the prices if another competitor comes onto the market. This discourages the competitors from even spending the time and money on FDA approval.
Two possible solution to this: (1) reduce the cost of FDA approval for companies that want to make generic copies; or (2) impose taxes or price caps on FDA products that have no competition and command market power.
This all assumes patents are not involved (as is the case here), but both solutions would reduce the intensive for companies to game a system that is intended to make sure only safe products make it onto the market.
> The strict FDA requirements are there to make sure only safe and effective products come onto the market
How did this product fail then?
How did this product fail then?
The letter is not about the drug.
It's about the drug delivery device (i.e. the "pen"), and the failure of Pfizer/Meridian (the contract manufacturer of the device) to follow correct design and manufacturing practices.
They don't have a proper CAPA system in place, they don't have proper design control or procedures, the DHFs are missing up to date inputs, risk analysis isn't up to date, etc.
It's pretty damning, but it's not about the pharma aspect of this. Basically the manufacturer lacks a functional quality system, which is table stakes for this stuff.
It's about the drug delivery device (i.e. the "pen"), and the failure of Pfizer/Meridian (the contract manufacturer of the device) to follow correct design and manufacturing practices.
They don't have a proper CAPA system in place, they don't have proper design control or procedures, the DHFs are missing up to date inputs, risk analysis isn't up to date, etc.
It's pretty damning, but it's not about the pharma aspect of this. Basically the manufacturer lacks a functional quality system, which is table stakes for this stuff.
I would guess because once approved, the FDA has a much more limited role. I believe they can force a recall though. Technically the problem was mechanical, not pharmaceutical. I'm not sure if that had anything to do with it though.
I myself am kinda glad it is not easy to put a medication to market. However, big pharma is quite proficient at dealing with regulatory bodies already since they have so many products on the market, so I don't think that's tthe main reason
The FDA won't approve any of them†. There are a number of alternatives in Europe, but they can't legally sell them in the US (except for one and it's under some silly restrictions that keep it from being used more widely.)
†Or sets the cost of approval to be vastly higher than any potential profits, which is effectively the same thing.
†Or sets the cost of approval to be vastly higher than any potential profits, which is effectively the same thing.
How is it a problem to get FDA approval for big pharma like Merck, for instance?
How do you prevent collusion between big players in a free market?
Here is an example, they are simply rejected by FDA without explanation how to proceed (until the shitstorm starts): http://www.post-gazette.com/business/healthcare-business/201...
>What exactly is preventing another company for creating an EpiPen clone?
Nothing. It's already done, it's just vanished from the news.
When the senators daughter was put in charge of epi-pen, first it was made mandatory in schools (so they had to buy it) then price was raised to $500 ( https://www.theguardian.com/commentisfree/2016/sep/22/epipen... )
So a 3D printed alternative was created. It costs $50 and can be made at home ( http://fortune.com/2016/09/15/epipen-alernative-cheap/ )
Nothing. It's already done, it's just vanished from the news.
When the senators daughter was put in charge of epi-pen, first it was made mandatory in schools (so they had to buy it) then price was raised to $500 ( https://www.theguardian.com/commentisfree/2016/sep/22/epipen... )
So a 3D printed alternative was created. It costs $50 and can be made at home ( http://fortune.com/2016/09/15/epipen-alernative-cheap/ )
What everyone else said, but also there's something around pharmacists have to fill the prescription as it's written, and cannot substitute generics.
So, if a dr writes "epipen" it needs to be an actual Epipn(TM) that gets handed over.
There's a UI aspect here too. Doctors use software, and if that software presents expensive non-generics first in the drop-down list that's the med that gets selected.
https://twitter.com/drmarkporter/status/765569736423927813
https://twitter.com/drmarkporter/status/765570038048911360
> Q for SystmOne GPs: is there a simple way to ensure default drugs offered when prescribing are cheapest versions most commonly prescribed?
> For context: our default omeprazole version (20mg) is currently 5 times price of one 4 down. Easily repeated costly error when busy.
So, if a dr writes "epipen" it needs to be an actual Epipn(TM) that gets handed over.
There's a UI aspect here too. Doctors use software, and if that software presents expensive non-generics first in the drop-down list that's the med that gets selected.
https://twitter.com/drmarkporter/status/765569736423927813
https://twitter.com/drmarkporter/status/765570038048911360
> Q for SystmOne GPs: is there a simple way to ensure default drugs offered when prescribing are cheapest versions most commonly prescribed?
> For context: our default omeprazole version (20mg) is currently 5 times price of one 4 down. Easily repeated costly error when busy.
That's not correct. If a brand name is listed, a generic can (and usually is) substituted. They (the pharmacists) only don't if "DAW" (Dispense As Written) is written as well.
Here is a state-by-state guide on how to write a prescription to ensure the brand name drug is not substituted.[1]
This is all not relevant though, as EpiPen is not considered to have a (non-Mylan) generic equivalent available.
[1] http://beta.aan.com/globals/axon/assets/4698.pdf
Here is a state-by-state guide on how to write a prescription to ensure the brand name drug is not substituted.[1]
This is all not relevant though, as EpiPen is not considered to have a (non-Mylan) generic equivalent available.
[1] http://beta.aan.com/globals/axon/assets/4698.pdf
Thalidomide.
You ever notice how the government likes to treat corporations like people, but corporations never go to prison? They get fined a marginal fraction of their yearly profits, or maybe in an extreme case an employee goes to jail, but the corporation continues to do what it was doing before. Basically, if you're incorporated, and you can find a fall guy, nothing can stop you - except maybe a drop in sales.
Corporate death penalty - dissolution of the corporation - is an easy concept (even if used far too infrequently). But I wonder what would be corporate equivalent of prison time? For individuals, incarceration is about limiting their usual freedoms. So how could it work for a corporate entity? A temporary suspension of the legal person status?
CEO and all board members get real jail time.
Charge them all with manslaughter, send a message.
Charge them all with manslaughter, send a message.
Corporate "jail time" would be indistinguishable from "death penalty" in practice: suspending a corporation's ability to engage in contracts and do business basically means the corporation rapidly falls apart, existing contracts run out or get cancelled, employees don't receive pay checks, etc.
Corporations are basically a sizable chunk of the privileges people lose when going to prison but without the physical reality that guarantees a continued existence. In practice that physical reality manifests itself in the form of the actual human beings running the company and making its decisions, obviously.
So considering a corporation is more like a person without direct agency that relies on the care and supervision of trusted persons, it seems obvious misbehaviour of corporations should be treated as criminal negligence on the part of its caretakers, the people running it.
Alternatively the people running it are the corporation's physical manifestation and therefore the ones who should go to prison if the corporation is jailed (like how when a natural person is sent to prison, they are physically imprisoned rather than merely having their bank accounts frozen).
But all this navelgazing aside, the US is a country where civil assets can be arrested as suspected accomplices to crimes without bringing up any charges against their owners (civil forfeiture). It's clear the "corporations are people" narrative only exists to let certain people have their cake and eat it too, not to make any sense if taken literally.
Corporations are basically a sizable chunk of the privileges people lose when going to prison but without the physical reality that guarantees a continued existence. In practice that physical reality manifests itself in the form of the actual human beings running the company and making its decisions, obviously.
So considering a corporation is more like a person without direct agency that relies on the care and supervision of trusted persons, it seems obvious misbehaviour of corporations should be treated as criminal negligence on the part of its caretakers, the people running it.
Alternatively the people running it are the corporation's physical manifestation and therefore the ones who should go to prison if the corporation is jailed (like how when a natural person is sent to prison, they are physically imprisoned rather than merely having their bank accounts frozen).
But all this navelgazing aside, the US is a country where civil assets can be arrested as suspected accomplices to crimes without bringing up any charges against their owners (civil forfeiture). It's clear the "corporations are people" narrative only exists to let certain people have their cake and eat it too, not to make any sense if taken literally.
> Corporate "jail time" would be indistinguishable from "death penalty" in practice: suspending a corporation's ability to engage in contracts and do business basically means the corporation rapidly falls apart, existing contracts run out or get cancelled, employees don't receive pay checks, etc.
How is this different from when a person goes to jail? They loose their job, house, many future chances for a job. We just don't kill people when they're unprofitable.
How is this different from when a person goes to jail? They loose their job, house, many future chances for a job. We just don't kill people when they're unprofitable.
Personal insolvency generally doesn't kill the person. Corporate insolvency typically results in the corporation being dissolved, effectively killing it.
I'm not arguing that this is a bad thing. If anything I'm arguing that corporations shouldn't be granted people privileges because they are demonstrably not people. And that if the corporation misbehaves that means people need to be held liable, too.
I'm not arguing that this is a bad thing. If anything I'm arguing that corporations shouldn't be granted people privileges because they are demonstrably not people. And that if the corporation misbehaves that means people need to be held liable, too.
Indicting a corporation (which is rare) is considered a "death sentence". Most other companies will not sign contracts with another company that has been Indicted (even if not convicted).
http://blogs.findlaw.com/blotter/2014/04/what-happens-when-a...
https://www.justice.gov/sites/default/files/criminal-fraud/l...
Civil or SEC prosecutions are totally different, of course.
http://blogs.findlaw.com/blotter/2014/04/what-happens-when-a...
https://www.justice.gov/sites/default/files/criminal-fraud/l...
Civil or SEC prosecutions are totally different, of course.
> But I wonder what would be corporate equivalent of prison time?
https://en.wikipedia.org/wiki/Consent_decree
https://en.wikipedia.org/wiki/Consent_decree
> A temporary suspension of the legal person status?
That's a start. A stronger limitation of their usual freedoms could also be modeled on the Voting Rights Act's preclearance[1] requirements. The corporation has the burden of proving to an independent regulatory panel that a proposed change will not have the effect of recreating the problem.
[1] https://en.wikipedia.org/wiki/Voting_Rights_Act_of_1965#Prec...
That's a start. A stronger limitation of their usual freedoms could also be modeled on the Voting Rights Act's preclearance[1] requirements. The corporation has the burden of proving to an independent regulatory panel that a proposed change will not have the effect of recreating the problem.
[1] https://en.wikipedia.org/wiki/Voting_Rights_Act_of_1965#Prec...
> But I wonder what would be corporate equivalent of prison time?
How about just prison time ? Corporations on their own can't do anything, they are just a legal fiction. The actual decisions are made and implemented by real human beings; they can be held responsible and put in jail.
How about just prison time ? Corporations on their own can't do anything, they are just a legal fiction. The actual decisions are made and implemented by real human beings; they can be held responsible and put in jail.
The executives should be held personally responsible for what the corporation does. In this case, people died so the CEO, CFO, etc. should all be sent to jail as if they had killed these people personally, their assets seized and distributed to the victims. I guarantee you that once you have real consequences for executives' actions, they will fix the problem immediately. That will never happen in our corporation first culture, however, but the culture might eventually change and demand justice. Stranger things have happened.
Putting a corporation 'in jail' is essentially a death sentence, since no corporation is realistically going to survive that process. That would have lasting, negative repercussions for people who have committed not crime beyond being employed by someone who did.
I completely agree that more robust methods for punishing criminal corporate acts are required, but those can take many other forms – and I'd personally side with individual responsibility for illegal actions.
I completely agree that more robust methods for punishing criminal corporate acts are required, but those can take many other forms – and I'd personally side with individual responsibility for illegal actions.
I'm not against personally prosecuting those in charge, but it's often extremely difficult to prove that specific individuals are responsible.
There is a simpler solution. Impose bigger fines. Much much bigger fines. Make the cost/benefit calculus for breaking rules so unattractive that the prudent business decision is to not break them.
Right now, when these companies are caught, they have to pay back what they stole, and sometimes get hit with a not so bad punitive damage. They should instead be hit with damages so hard that it kills their stock price, and does serious damage to the company itself. It will make the people in charge more careful.
There is a simpler solution. Impose bigger fines. Much much bigger fines. Make the cost/benefit calculus for breaking rules so unattractive that the prudent business decision is to not break them.
Right now, when these companies are caught, they have to pay back what they stole, and sometimes get hit with a not so bad punitive damage. They should instead be hit with damages so hard that it kills their stock price, and does serious damage to the company itself. It will make the people in charge more careful.
> I'm not against personally prosecuting those in charge, but it's often extremely difficult to prove that specific individuals are responsible.
But isn't that the whole reason CEO's get paid so much, because they carry so much responsibility ? Most corporations have a clear chain of command, should be quite easy to figure out who is responsible (which can be separate from who actually committed the crime).
But isn't that the whole reason CEO's get paid so much, because they carry so much responsibility ? Most corporations have a clear chain of command, should be quite easy to figure out who is responsible (which can be separate from who actually committed the crime).
>they carry so much responsibility?
How's that working out? It doesn't really seem to me that CEO's ARE carrying that responsibility.
Maybe it once was true, but it certainly is not anymore.
How's that working out? It doesn't really seem to me that CEO's ARE carrying that responsibility.
Maybe it once was true, but it certainly is not anymore.
No, but they use it as a justification for their ridiculous salaries so I’d say we take them up on it and hold them personally responsible for their company’s crimes.
The threat of corporations going to jail would be a great disincentive for them growing too large. I think we would be much better off if we had more smaller companies.
And their approach was to send a letter. That'll teach them.
This is part of the standard FDA procedure. It starts with a formal warning letter (they send out many of those each year, for varying degrees of severity), and give the company a chance to address the non-conformities and violations. If a company fails to address the issues found, further action is taken, as evidenced by this bit from the end of the letter:
"Correct the violations cited in this letter promptly. Failure to promptly correct these violations may result in legal action without further notice including, without limitation, seizure and injunction. Unresolved violations in this warning letter may also prevent other Federal agencies from awarding contracts."
I've recently browsed through these warning letters for educational purposes (they're all publicly published on the FDA website), and this is by far the sternest letter I've seen.
"Correct the violations cited in this letter promptly. Failure to promptly correct these violations may result in legal action without further notice including, without limitation, seizure and injunction. Unresolved violations in this warning letter may also prevent other Federal agencies from awarding contracts."
I've recently browsed through these warning letters for educational purposes (they're all publicly published on the FDA website), and this is by far the sternest letter I've seen.
A warning letter from the FDA is quite serious. The executives would ignore it at their peril.
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/u...
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/u...
Want to see a stronger response? Then elect someone to the Presidency in 2020 who promises to strengthen regulations.
[deleted]
Well, that presumes that the promises would be kept
And you agree with everything else they stand for, or only care about this single issue. In reality it's nowhere near as simple as that.
Maybe you shouldn't put so much emphasis on the executive. They're just meant to enforce the laws, it's congress's job to write them.
Ah yes! Because "regulations" don't exist.
I agree with you, but 99% of people here want the executive to do a lot more than it really should.
Think net neutrality...
(Karmaship down.)
I agree with you, but 99% of people here want the executive to do a lot more than it really should.
Think net neutrality...
(Karmaship down.)
we have not really had a major corporate prosecution with Executives going to jail since probably Enron scandal.
I'd be surprised to see big pharma CEO in jail these days. especially politically connected.
I'd be surprised to see big pharma CEO in jail these days. especially politically connected.
Results:
* no punitive action taken by regulators
* sales increase as parents buy more epipens just to make sure
Good work FDA. Serving your real constituents as usual.
* no punitive action taken by regulators
* sales increase as parents buy more epipens just to make sure
Good work FDA. Serving your real constituents as usual.
This comment by Cozumel needs more discussion:
"Maybe the fact her mommy is President of the National Association of State Boards of Education and drafted a law making them mandatory for schools to buy, then her husband lobbied for the law, once it became mandatory for schools to stock them they hiked the price to $500."
Edit to add links:
https://en.wikipedia.org/wiki/Joe_Manchin
https://en.wikipedia.org/wiki/Heather_Bresch
https://en.wikipedia.org/wiki/Gayle_Conelly_Manchin
"Maybe the fact her mommy is President of the National Association of State Boards of Education and drafted a law making them mandatory for schools to buy, then her husband lobbied for the law, once it became mandatory for schools to stock them they hiked the price to $500."
Edit to add links:
https://en.wikipedia.org/wiki/Joe_Manchin
https://en.wikipedia.org/wiki/Heather_Bresch
https://en.wikipedia.org/wiki/Gayle_Conelly_Manchin
We'll be seeing more and more of this as capitalism goes through its death throes. The next 20 years aren't going to be pretty.
The rumours of it's death are greatly exaggerated.
Environmental catastrophe is the only likely trigger I can see. Without that, capitalism will adapt and survive - of course with the inevitable pendulum shifts between it's more authoritarian and more benign forms.
A final thought - are people using the term in a clearly defined way or is it just a label for "that bad stuff" from the left and "freeeedom" from the right?
Environmental catastrophe is the only likely trigger I can see. Without that, capitalism will adapt and survive - of course with the inevitable pendulum shifts between it's more authoritarian and more benign forms.
A final thought - are people using the term in a clearly defined way or is it just a label for "that bad stuff" from the left and "freeeedom" from the right?
Capitalism won't die. Representative government, civil rights, and the ability of the average person to control their own labor will, but greed is eternal.
There are a couple 19th century Hegelian philosophers who would love to have a conversation with you.
'Manchin was the only Democrat to vote in confirmation of controversial Trump cabinet appointees Jeff Sessions[87] and Steven Mnuchin,[88] one of two Democrats who voted to confirm Scott Pruitt as EPA Administrator, and one of three who voted to confirm Rex Tillerson.'
and politically well connected. Would be surprised if anything would happen, at all. Just like the last pricing scandal, which was barely a year ago:
http://fortune.com/2016/09/27/mylan-epipen-heather-bresch/