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FDA slams EpiPen maker

178 points| Tomte | 8 years ago |arstechnica.com

115 comments

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[+] naturalgradient|8 years ago|reply
The CEO is daughter of senator https://en.wikipedia.org/wiki/Joe_Manchin

'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/

[+] thriftwy|8 years ago|reply
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!

[+] iliketosleep|8 years ago|reply
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.
[+] burnte|8 years ago|reply
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.
[+] mhandley|8 years ago|reply
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.
[+] d--b|8 years ago|reply
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.
[+] curiousgeorgio|8 years ago|reply
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.

[+] Clubber|8 years ago|reply
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?

[+] carlmr|8 years ago|reply
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.

[+] scott_s|8 years ago|reply
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.
[+] jcranberry|8 years ago|reply
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?
[+] steeve|8 years ago|reply
What exactly is preventing another company for creating an EpiPen clone?
[+] peterwwillis|8 years ago|reply
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.
[+] TeMPOraL|8 years ago|reply
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?
[+] mnm1|8 years ago|reply
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.
[+] matthewmacleod|8 years ago|reply
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.

[+] deelowe|8 years ago|reply
And their approach was to send a letter. That'll teach them.
[+] jeroen94704|8 years ago|reply
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.

[+] aaronbrethorst|8 years ago|reply
Want to see a stronger response? Then elect someone to the Presidency in 2020 who promises to strengthen regulations.
[+] readhn|8 years ago|reply
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.

[+] lowbloodsugar|8 years ago|reply
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.

[+] electriclove|8 years ago|reply
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

[+] beedogs|8 years ago|reply
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.
[+] andybak|8 years ago|reply
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?

[+] _jal|8 years ago|reply
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.
[+] bmmayer1|8 years ago|reply
There are a couple 19th century Hegelian philosophers who would love to have a conversation with you.