General Discussion
Related: Editorials & Other Articles, Issue Forums, Alliance Forums, Region ForumsThere 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.
annabanana
(52,791 posts)Re-dedication to mission, new personnel, funding and TEETH.
madokie
(51,076 posts)who runs the place?
Lots of questions concerning our government operation
former9thward
(32,009 posts)He has appointed two, the first starting in May, 2009.
Sherman A1
(38,958 posts)hit the nail on the head there.
ehrnst
(32,640 posts)Believe me, they are a bunch of aging hippies, and are not to blame for this whatsoever.
ehrnst
(32,640 posts)he lack of a cheaper version of Mylan NVs EpiPen shot may come down to a dispute between drugmakers over a plastic cap.
Unlike Mylans 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 Tevas 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 wouldnt 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 companys 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 thats 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 its not.
http://www.bloomberg.com/news/articles/2016-08-31/plastic-cap-is-crux-of-mylan-argument-against-competing-epipen
DetlefK
(16,423 posts)The patent was granted in 1987.
http://www.drugpatentwatch.com/p/tradename/EPIPEN
Patents are valid for 20 years maximum.
https://en.wikipedia.org/wiki/Term_of_patent_in_the_United_States
So why hasn't the patent run out in 2007?
AngryAmish
(25,704 posts)But small changes are made and the device gets repatented then approved by the crooked FDA.
Bradical79
(4,490 posts)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)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)"Who cares if some kids die of anaphylactic shock..."
Certainly not the individual whose best and finest solution is merely calling others a 'mark.'
AngryAmish
(25,704 posts)bucolic_frolic
(43,167 posts)Monopoly pricing power politically granted
turbinetree
(24,703 posts)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)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?
MynameisBlarney
(2,979 posts)Somethings gotta give, and soon.
rurallib
(62,416 posts)Cryptoad
(8,254 posts)The Green Manalishi
(1,054 posts)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".
classykaren
(769 posts)Act_of_Reparation
(9,116 posts)KittyWampus
(55,894 posts)AngryAmish
(25,704 posts)That is why it is so crooked.
KittyWampus
(55,894 posts)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)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.
KittyWampus
(55,894 posts)it sank like a stone.
TexasBushwhacker
(20,190 posts)There's no reason for them to not stock the generics and offer the same price as Walmart. NONE
Thinkingabout
(30,058 posts)Lee-Lee
(6,324 posts)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)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.
Lee-Lee
(6,324 posts)Avalux
(35,015 posts)Makes it difficult for any generic co. to prove their product is equivalent.
http://www.fiercepharma.com/drug-delivery/could-a-plastic-cap-epipen-have-given-mylan-its-market-dominance
undergroundpanther
(11,925 posts)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