FDA slams EpiPen maker
arstechnica.com
arstechnica.com
'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:
It's as if nobody else wants to sit in that chair!
To be fair, assuming no other malfeasance requires a pretty big leap of faith...
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.
“People.”
(From the second book in the altered carbon series)
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.
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.
That's not a given.
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
There is definitely a market failure here, but it's not clear why.
This is why some countries have enacted laws to help with that.
https://www.statnews.com/2016/08/25/mylan-antitrust-epipen-s...
"They keep trying, and the FDA keeps refusing to approve them for human use."
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.
If people start to pay attention to the process and the corruption surrounding EpiPen, will it blow the lid off the entire FDA system?
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.
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.
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.
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.
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 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.
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.
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.
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.
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.
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.
You could easily replace "free markets" with "communism" and make the same statement.
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 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.
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... )
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.
How did this product fail then?
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.
†Or sets the cost of approval to be vastly higher than any potential profits, which is effectively the same thing.
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/ )
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.
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.
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?
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.
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
Fraud != intent to lose people's money was literally the point of my post.
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...
So if the government didn't solve those problems, what did? 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).
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.
Charge them all with manslaughter, send a message.
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.
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.
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.
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...
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.
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.
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.
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.
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).
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.
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.)
"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.
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/u...
I'd be surprised to see big pharma CEO in jail these days. especially politically connected.
* 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.
"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
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?