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AngryAmish

(25,704 posts)
Wed Sep 7, 2016, 07:29 AM Sep 2016

There are eight Epipens alternatives in Europe. Our FDA will not approve them here

http://slatestarcodex.com/2016/08/29/reverse-voxsplaining-drugs-vs-chairs/

The manufacturer of the Epipen has captured their regulator, the FDA.

Yes the system is rigged. It is rigged against you. And if you do not believe it then you are a mark.

It hurts to be called a mark. So one denies it. But the first step in not being a chump is to think that things may not be on the level.
33 replies = new reply since forum marked as read
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There are eight Epipens alternatives in Europe. Our FDA will not approve them here (Original Post) AngryAmish Sep 2016 OP
The FDA is in serious need of an overhaul . . annabanana Sep 2016 #1
How many bush/cheney holdovers are still there madokie Sep 2016 #2
The Commissioner is appointed by Obama. former9thward Sep 2016 #32
Agreed Sherman A1 Sep 2016 #3
I know people working in the FDA labs ehrnst Sep 2016 #11
The reason that the Israeli generic is not being approved by the FDA ehrnst Sep 2016 #20
Wait... Shouldn't the Epipen-patent have expired by now? DetlefK Sep 2016 #4
The fundamental reason is the market is rigged by insiders AngryAmish Sep 2016 #5
Going by the article, the patent isn't the problem anymore Bradical79 Sep 2016 #17
There is a reason a Senator's daughter runs the company that makes Epipens AngryAmish Sep 2016 #6
Certainly not the individual whose best and finest solution is merely calling others a 'mark.' LanternWaste Sep 2016 #7
Would you prefer stooge or chump? AngryAmish Sep 2016 #8
Monopoly for all intents and purposes bucolic_frolic Sep 2016 #9
Disgusting and Angry Amish is Correct we are marks turbinetree Sep 2016 #10
The FDA, like all regulatory agencies have been co-opted by the industry they regulate. Dustlawyer Sep 2016 #12
This country is so fucked up MynameisBlarney Sep 2016 #13
sorry they only let me rec this once rurallib Sep 2016 #14
Corporte Socialism at its best Cryptoad Sep 2016 #15
Approval should be the default for anything unless PROVEN unsafe The Green Manalishi Sep 2016 #16
What does the pen cost in Canada? classykaren Sep 2016 #18
$120, when last I checked. n/t Act_of_Reparation Sep 2016 #19
Adrenaclick is available here. It's MADE here too. The OP is false. KittyWampus Sep 2016 #21
The problem is a law that does not allow generic substitution for Epipens AngryAmish Sep 2016 #24
that simply means the doctors prescribe Adrenaclick or the generic... KittyWampus Sep 2016 #31
The problem is "Epipen" has become the "Xerox" of autoinjectors TexasBushwhacker Sep 2016 #22
Thank You. I've posted this over and over and over again. I started an OP KittyWampus Sep 2016 #23
People need to put the pressure on pharmacies as well TexasBushwhacker Sep 2016 #25
We could do a better job with our health care. Thinkingabout Sep 2016 #26
Libertarians have been all over screaming this is a government caused problem Lee-Lee Sep 2016 #27
It's the way the laws are set up here. Mylan has a patent and total control. Avalux Sep 2016 #28
Epinephrine and auto-injectors are both long off patent Lee-Lee Sep 2016 #29
Mylan has a patent on their proprietary technology. Avalux Sep 2016 #30
Shit like this undergroundpanther Sep 2016 #33

annabanana

(52,791 posts)
1. The FDA is in serious need of an overhaul . .
Wed Sep 7, 2016, 07:32 AM
Sep 2016

Re-dedication to mission, new personnel, funding and TEETH.

madokie

(51,076 posts)
2. How many bush/cheney holdovers are still there
Wed Sep 7, 2016, 07:37 AM
Sep 2016

who runs the place?

Lots of questions concerning our government operation

 

ehrnst

(32,640 posts)
11. I know people working in the FDA labs
Wed Sep 7, 2016, 08:49 AM
Sep 2016

Believe me, they are a bunch of aging hippies, and are not to blame for this whatsoever.

 

ehrnst

(32,640 posts)
20. The reason that the Israeli generic is not being approved by the FDA
Wed Sep 7, 2016, 11:01 AM
Sep 2016
http://www.bloomberg.com/news/articles/2016-08-31/plastic-cap-is-crux-of-mylan-argument-against-competing-epipen


he lack of a cheaper version of Mylan NV’s EpiPen shot may come down to a dispute between drugmakers over a plastic cap.
Unlike Mylan’s one-cap EpiPen, Teva Pharmaceutical Industries Ltd.’s proposed substitutable generic version has two caps, including a removable one that covers the spot where its needle extends. In a petition to the U.S. Food and Drug Administration, Mylan cited that difference as the key reason the agency should reject Teva’s generic -- which is exactly what happened in February of this year.

Nina Devlin, a Mylan spokeswoman, said the company asked the FDA to only approve the competing devices if they were truly equivalent, and wouldn’t pose a risk of confusing patients who were having an emergency. “We expressed our concern that the product may not meet the standards, and therefore presents distinct risks,” she said in an e-mail Wednesday. Denise Bradley, a Teva spokeswoman, declined to comment on the company’s conversations with the FDA.

The basic design of the EpiPen has been around since the 1980s, when doctors touted the then-new device as an easy way for patients to self-administer doses of epinephrine, a hormone synthesized about 100 years ago that’s long been used to treat serious reactions from bee stings and food allergies.

‘Difference in Design’

“The difference in design leads to a slight difference in operability,” said Ronny Gal, an analyst with Sanford C. Bernstein & Co. “Teva says, ‘Ours is good enough,’ and Mylan is saying it’s not.”

http://www.bloomberg.com/news/articles/2016-08-31/plastic-cap-is-crux-of-mylan-argument-against-competing-epipen
 

AngryAmish

(25,704 posts)
5. The fundamental reason is the market is rigged by insiders
Wed Sep 7, 2016, 08:04 AM
Sep 2016

But small changes are made and the device gets repatented then approved by the crooked FDA.

 

Bradical79

(4,490 posts)
17. Going by the article, the patent isn't the problem anymore
Wed Sep 7, 2016, 10:17 AM
Sep 2016

I think I read that right. The company lost their patent defense in court, but the FDA wouldn't approve the alternate for vaugue reasons. Would like to see some more in depth investigative work on that.

 

AngryAmish

(25,704 posts)
6. There is a reason a Senator's daughter runs the company that makes Epipens
Wed Sep 7, 2016, 08:16 AM
Sep 2016

If one reads the article it is mentioned that every year some do-gooder files a bill that would take away the monopoly from Mylan.

Every year the bill dies. In the Senate.

But who cares. There are yachts to buy. Who cares if some kids die of anaphylactic shock.

 

LanternWaste

(37,748 posts)
7. Certainly not the individual whose best and finest solution is merely calling others a 'mark.'
Wed Sep 7, 2016, 08:37 AM
Sep 2016

"Who cares if some kids die of anaphylactic shock..."

Certainly not the individual whose best and finest solution is merely calling others a 'mark.'

turbinetree

(24,703 posts)
10. Disgusting and Angry Amish is Correct we are marks
Wed Sep 7, 2016, 08:46 AM
Sep 2016

The FDA Now Officially Belongs to Big Pharma
Robert Califf's ties to Big Pharma run deep and the Obama nominee just sailed through the U.S. Senate.

http://www.alternet.org/news-amp-politics/fda-now-officially-belongs-big-pharma

Dustlawyer

(10,495 posts)
12. The FDA, like all regulatory agencies have been co-opted by the industry they regulate.
Wed Sep 7, 2016, 08:59 AM
Sep 2016

All agencies are under-funded and headed by industry insiders. It is so bad that refineries and chemical plants self-report there accidents and leaks. The EPA cannot inspect them all in 10 years, they are just reactive.

Corporations control and run this country. Their Lobbyiests pay for the laws they want with perks and campaign contributions. Congress quietly gave themselves back the legal right to insider trade, getting stock tips from Wall Street in exchange for more favors.

How corrupt does it have to get before we do something about it?

The Green Manalishi

(1,054 posts)
16. Approval should be the default for anything unless PROVEN unsafe
Wed Sep 7, 2016, 09:46 AM
Sep 2016

Very, VERY few things should be illegal.

I'll take my chances with anything short of radioactive waste or the Ebola virus before I fucking trust any entity ending with an "Incorporated".

 

AngryAmish

(25,704 posts)
24. The problem is a law that does not allow generic substitution for Epipens
Wed Sep 7, 2016, 11:14 AM
Sep 2016

That is why it is so crooked.

 

KittyWampus

(55,894 posts)
31. that simply means the doctors prescribe Adrenaclick or the generic...
Wed Sep 7, 2016, 01:34 PM
Sep 2016

And a part of why pharmacists can't switch without a prescription is because the auto-injectors work differently and consumers would need to be aware of that.

TexasBushwhacker

(20,190 posts)
22. The problem is "Epipen" has become the "Xerox" of autoinjectors
Wed Sep 7, 2016, 11:11 AM
Sep 2016

There is an alternative in the US called Adrenaclick by Lineage Therapeutics. It costs half of what Epipen costs; about $350 for a 2 pack. They also manufacture a generic version that costs about $150 at Walmart and Sam's.

All you have to do is ask your doctor to write the script for "Adrenaclick" and "generic allowed". If you have insurance, make sure they cover it.

TexasBushwhacker

(20,190 posts)
25. People need to put the pressure on pharmacies as well
Wed Sep 7, 2016, 11:14 AM
Sep 2016

There's no reason for them to not stock the generics and offer the same price as Walmart. NONE

 

Lee-Lee

(6,324 posts)
27. Libertarians have been all over screaming this is a government caused problem
Wed Sep 7, 2016, 11:31 AM
Sep 2016

By not allowing competition and creating a monopoly.

I've tried to argue against that and show its just greed- but in the end it looks like corporate greed that's being enabled by bad governance.

Avalux

(35,015 posts)
28. It's the way the laws are set up here. Mylan has a patent and total control.
Wed Sep 7, 2016, 11:51 AM
Sep 2016

Last edited Wed Sep 7, 2016, 12:46 PM - Edit history (1)

Because of that, the companies in Europe making generic versions of the Epi-Pens cannot sell them here.

As if that's not bad enough, diabolical corporate tax deserter Mylan has cleverly figured out a way around their own patent - by releasing a generic version of the Epi-pen. This is touted as a way to help people (after the price raise blunder), but it really is just about profit.

Their plan is to continue to corner the market even when the patent expires and there are more generic versions of the Epi-pen available to consumers.

undergroundpanther

(11,925 posts)
33. Shit like this
Wed Sep 7, 2016, 09:28 PM
Sep 2016

Is why I am anti patent and anti copyright. You don't own what you say....nobody can own air...the idea is a lie down to it's core .some asshole tried to copyright the word the. It exists for money and greed alone.capitalism the psychopath system that enslaves and destroys all for control. Via money like tokens like we all are Skinners pigeons now. Paying the outrageous price from a legalized monopoly cartel for a long ago invented drug to live...as if mylan owned us and had the right to own epinephrine and how one gets it into ones body. Who let's Mylan get away with extortion?
Pidgeons who refuse to reject their masters giving them tokens to buy epipens with.
Imho

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