
FDA slams EpiPen maker - Tomte
https://arstechnica.com/science/2017/09/fda-slams-epipen-maker-for-doing-nothing-while-hundreds-failed-people-died/
======
naturalgradient
The CEO is daughter of senator
[https://en.wikipedia.org/wiki/Joe_Manchin](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/](http://fortune.com/2016/09/27/mylan-epipen-heather-bresch/)

~~~
thriftwy
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!

~~~
KGIII
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...

~~~
thriftwy
One only have to unearth a small connection between two entities to drown them
both (and take the chair).

~~~
rayiner
What is the scandal that warrants “drowning them both?” That a Senator has a
daughter who is a CEO? What else?

~~~
Cozumel
>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.

~~~
mcgoo
Textbook rent-seeking.

------
iliketosleep
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
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.

~~~
mtgx
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.

~~~
rixed
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?

~~~
contravariant
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

~~~
rixed
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.

------
curiousgeorgio
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.

~~~
steeve
What exactly is preventing another company for creating an EpiPen clone?

~~~
curiousgeorgio
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.

~~~
matthewmacleod
_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.

~~~
curiousgeorgio
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.

~~~
matthewmacleod
_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.

~~~
curiousgeorgio
>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.

------
peterwwillis
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
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?

~~~
pluma
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.

~~~
jimktrains2
> 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.

~~~
pluma
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.

------
deelowe
And their approach was to send a letter. That'll teach them.

~~~
aaronbrethorst
Want to see a stronger response? Then elect someone to the Presidency in 2020
who promises to strengthen regulations.

~~~
srean
Well, that presumes that the promises would be kept

~~~
simonh
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.

~~~
Filligree
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.

~~~
tertius
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.)

------
readhn
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
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
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/Joe_Manchin)

[https://en.wikipedia.org/wiki/Heather_Bresch](https://en.wikipedia.org/wiki/Heather_Bresch)

[https://en.wikipedia.org/wiki/Gayle_Conelly_Manchin](https://en.wikipedia.org/wiki/Gayle_Conelly_Manchin)

------
beedogs
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
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?

