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Link Posted: 8/25/2016 10:50:01 PM EDT
[#1]
Monopolies Gonna Monopoly.





I can almost guarantee there is a government regulation that is the primary cause of this situation.



ETA:  Read the article, and sure enough, I was right.



 
Link Posted: 8/25/2016 11:09:39 PM EDT
[#2]
Discussion ForumsJump to Quoted PostQuote History
Quoted:
OP is an expired epi pen really not usable?
View Quote


The answer is depends.
Epinephrine isn't particularly stable and exposure to high heat or UV light can very quickly degrade it to the point that it is completely ineffective.
The manufactures expiration date is based on stability studies within their prescribed storage conditions with a bit of a buffer.
Best course of action is to have an in date pen or ampule and store it appropriately and rotate it out of service when expired.

And whoever is recommending pre-drawing up the syringes STOP!.  Sterility concerns aside drawing epi up in a standard plastipak syringe will degrade to useless in a matter of days.
Link Posted: 8/25/2016 11:11:35 PM EDT
[#3]

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Quoted:
You can believe whatever you want about the evil biotechs and the greedy CEOs...facts are fact.



If you want to go after the biggest cost drivers in the EpiPen, Mylan isn't the place to start.

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Quoted:


Quoted:

CNBC and the CEO of Mylan just explained that 55% of the price of an EpiPen is added by entities other than* Mylan.

 

$274+$334=$608.



So let's go after Mylan.



* Pharmacy Benefit Managers, wholesalers/distributors, etc.
Her excuse is BS. 55% of that price is not added by others outside of Mylan. She's lying and stupid since it is easily debunked.



WAC=wholesale acquisition cost (aka-Mylan's price for the drug to wholesalers and distributor)  



http://www.post-gazette.com/business/healthcare-business/2016/08/24/EpiPen-pricing-fuels-new-debate-over-drug-pricing/stories/201608240069



During the company’s Aug. 9 earnings call, Mylan CEO Heather Bresch defended the EpiPen’s pricing, saying, "If you look on an annual basis, as a lifesaving drug, to have a WAC [wholesale acquisition cost] price at just under $600, I think that you can see it falls as not an expensive product.”




You can believe whatever you want about the evil biotechs and the greedy CEOs...facts are fact.



If you want to go after the biggest cost drivers in the EpiPen, Mylan isn't the place to start.

She gave you lies, I gave you the facts. Choosing not to believe it is your problem.



Hmmm. She says 55% of the drug is because of other people to the public after public outcry. But a call to investors this very month says they (Mylan) charge wholesalers just under $600 for it.  




Just to be sure, I checked with our pharmacy distributor (I work for a company that buys from them). What Mylan charges them for EpiPen supports my claim.




Mylan is the sole driver for the costs.
Link Posted: 8/25/2016 11:17:09 PM EDT
[#4]
Discussion ForumsJump to Quoted PostQuote History
Quoted:
OP is an expired epi pen really not usable?
View Quote


It depends on how it was stored, most of the time it's still good but there's a chance that it will be ineffective or dangerous.
Link Posted: 8/25/2016 11:18:50 PM EDT
[#5]
Link Posted: 8/25/2016 11:21:51 PM EDT
[#6]
Corbett Report's James Corbett, who also does The International Forecaster, says the gouging is tied to the Klinton  Foundaiton.  https://www.youtube.com/watch?v=ApW8sNbOru8.  Not to blame the Klinton Foundation but the company that makes it (and gouges) is a donor and partner with the Klinton Foundation.
Link Posted: 8/25/2016 11:48:43 PM EDT
[#7]
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Corbett Report's James Corbett, who also does The International Forecaster, says the gouging is tied to the Klinton  Foundaiton.  https://www.youtube.com/watch?v=ApW8sNbOru8.  Not to blame the Klinton Foundation but the company that makes it (and gouges) is a donor and partner with the Klinton Foundation.
View Quote

What level of price or profit constitutes "gouging?"
Link Posted: 8/26/2016 12:00:25 AM EDT
[#8]
Did I just stumble into the DU?

This is capitalism. Deal with it.

They can charge what they like. Another company is free to create an alternative that costs less and corners the market.


Link Posted: 8/26/2016 12:04:17 AM EDT
[#9]

Discussion ForumsJump to Quoted PostQuote History
Quoted:


Did I just stumble into the DU?



This is capitalism. Deal with it.



They can charge what they like. Another company is free to create an alternative that costs less and corners the market.





View Quote
You know how I know you didn't read the thread or any links...

 
Link Posted: 8/26/2016 12:08:43 AM EDT
[#10]
Discussion ForumsJump to Quoted PostQuote History
Quoted:
Did I just stumble into the DU?

This is capitalism. Deal with it.

They can charge what they like. Another company is free to create an alternative that costs less and corners the market.


View Quote


Know how I know you didn't read, either?

It's NOT capitalism when you pay off the gov to kneecap your competition so you have a monopoly on a drug you didn't spend any money creating and a device developed by the gov.
Link Posted: 8/26/2016 12:11:37 AM EDT
[#11]
Discussion ForumsJump to Quoted PostQuote History
Quoted:


So use glass syringes.
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Discussion ForumsJump to Quoted PostQuote History
Quoted:
Quoted:
Quoted:
OP is an expired epi pen really not usable?


The answer is depends.
Epinephrine isn't particularly stable and exposure to high heat or UV light can very quickly degrade it to the point that it is completely ineffective.
The manufactures expiration date is based on stability studies within their prescribed storage conditions with a bit of a buffer.
Best course of action is to have an in date pen or ampule and store it appropriately and rotate it out of service when expired.

And whoever is recommending pre-drawing up the syringes STOP!.  Sterility concerns aside drawing epi up in a standard plastipak syringe will degrade to useless in a matter of days.


So use glass syringes.


That's an option but 99.99% of the 1ml syringes available on the market are going to be 1ml slip tip or luer plastic TB syringes. Very few glass small volume syringes out there and most of those are for specialty use. Good luck for Joe Sixpack trying to put together the bootleg epi kit at his local pharmacy.
Knowledge of drug delivery/storage isn't exactly in Joe sixpack's wheelhouse.
Link Posted: 8/26/2016 12:17:15 AM EDT
[#12]
Discussion ForumsJump to Quoted PostQuote History
Quoted:
No how I know you didn't read, either?

It's NOT capitalism when you pay off the gov to kneecap your competition so you have a monopoly on a drug you didn't spend any money creating and a device developed by the gov.
View Quote


Sounds exactly like capitalism to me.  It's using the tools available to it to extract money from people.
Link Posted: 8/26/2016 12:17:29 AM EDT
[#13]
Discussion ForumsJump to Quoted PostQuote History
Quoted:


No how I know you didn't read, either?

It's NOT capitalism when you pay off the gov to kneecap your competition so you have a monopoly on a drug you didn't spend any money creating and a device developed by the gov.
View Quote View All Quotes
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Discussion ForumsJump to Quoted PostQuote History
Quoted:
Quoted:
Did I just stumble into the DU?

This is capitalism. Deal with it.

They can charge what they like. Another company is free to create an alternative that costs less and corners the market.




No how I know you didn't read, either?

It's NOT capitalism when you pay off the gov to kneecap your competition so you have a monopoly on a drug you didn't spend any money creating and a device developed by the gov.


Sure.  

The regulatory environment is part of doing business. They got their device approved and is the best at what it does. Manufacturer raises prices. That's capitalism.

But, here's the important part, and it's not a load of hearsay,  capitalism kicks in again and it's now more profitable for another company to spend money on r&d to create a competitor.

You guys are being short sighted. This is how capitalism works.

Another company will create a competitor now that there's money to be made, and if they have to bribe or lobby their way to approval that will happen too.


Link Posted: 8/26/2016 12:21:35 AM EDT
[#14]
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Quoted:


Its in Ontario, Canada

A 6 hour drive for me.  Ive been lucky the last few  years, as either work, or the VA has replaced my pens.  But Im no longer lucky......





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25 years ago you had a pre filled syringe with a twistable plunger that would give you 3 or 4 doses of Epi, you just had to twist the plunger for the next dose. This came in a red plastic box about wallet sized, Then you had Atrophine auto injectors.

At some point they started putting Epi in the Auto injectors, changed the colors and now are charging out the ass for them.

Even with the cost of a new passport, its worth it to me to drive to Windsor to get new pens.







Where is Windsor and how do you get new epi-pens there?


Its in Ontario, Canada

A 6 hour drive for me.  Ive been lucky the last few  years, as either work, or the VA has replaced my pens.  But Im no longer lucky......







Does my teen have to see a dr there or can I just take a prescription? I'm asking in all seriousness b/c I have no idea how Canada's medical/pharmacy system works.
Link Posted: 8/26/2016 12:22:19 AM EDT
[#15]
Discussion ForumsJump to Quoted PostQuote History
Quoted:


The answer is depends.
Epinephrine isn't particularly stable and exposure to high heat or UV light can very quickly degrade it to the point that it is completely ineffective.
The manufactures expiration date is based on stability studies within their prescribed storage conditions with a bit of a buffer.
Best course of action is to have an in date pen or ampule and store it appropriately and rotate it out of service when expired.

And whoever is recommending pre-drawing up the syringes STOP!.  Sterility concerns aside drawing epi up in a standard plastipak syringe will degrade to useless in a matter of days.
View Quote View All Quotes
View All Quotes
Discussion ForumsJump to Quoted PostQuote History
Quoted:
Quoted:
OP is an expired epi pen really not usable?


The answer is depends.
Epinephrine isn't particularly stable and exposure to high heat or UV light can very quickly degrade it to the point that it is completely ineffective.
The manufactures expiration date is based on stability studies within their prescribed storage conditions with a bit of a buffer.
Best course of action is to have an in date pen or ampule and store it appropriately and rotate it out of service when expired.

And whoever is recommending pre-drawing up the syringes STOP!.  Sterility concerns aside drawing epi up in a standard plastipak syringe will degrade to useless in a matter of days.


I found this earlier today, when I was wondering how 'stale' my '03 and '05 expiry dates really were:

"An April 2015 study in the Annals of Allergy, Asthma & Immunology looked at 35 expired EpiPens from patients in Florida and found that injectors that were up to two years past their expiration date could potentially retain 90 percent or more of the initial dose listed on labeling. However, given the potential that anaphylaxis could be life-threatening, you should not rely on expired auto injectors for treatment. Even if you think the expired pen has worked, it’s still important to seek emergency medical care as soon as you inject, just as you should any time you use an epinephrine injector."

http://www.consumerreports.org/drugs/how-to-get-cheaper-epipen-alternative/

Chris
Link Posted: 8/26/2016 12:27:46 AM EDT
[#16]
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Quoted:


Wonder how many shares of Mylan Labs that Manchin owns?

This would be shouted from the rooftops if it was a Republican.
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Huh. Who'd have thought there may other aspects to the rise in prices? Manchin's daughter is the CEO of Mylan.

http://www.americanthinker.com/blog/2016/08/why_mylan_labs_is_being_scapegoated_by_the_political_class.html

In late 2013, President Barack Obama signed legislation aimed at increasing the nationwide availability of epinephrine in schools. After passage of The School Access to Emergency Epinephrine Act, twelve states now require schools to stock this medication
, while, with the exception of Hawaii, forty seven states recommend making it available.
-----------------
Schools have become a significant source of demand for the stocking of Mylan’s EpiPen product as school boards, administrators, legislators and health advocates have pushed for its availability.
---------------
School boards or in other words, taxpayers footing the bill. Hmmm...another win win for democrat pocket books. Wonder how much Mylan and Manchin's daughter have contributed to obutthole and democrats.

Yep, legislate a drug delivery system (since that's what this is all really about and not the drug) and make it a mandate for the PSS then sit back and say "who me?"
 


Wonder how many shares of Mylan Labs that Manchin owns?

This would be shouted from the rooftops if it was a Republican.


HELL YES IT WOULD. The biased media is disgusting.
Link Posted: 8/26/2016 12:28:05 AM EDT
[#17]
Discussion ForumsJump to Quoted PostQuote History
Quoted:


That's an option but 99.99% of the 1ml syringes available on the market are going to be 1ml slip tip or luer plastic TB syringes. Very few glass small volume syringes out there and most of those are for specialty use. Good luck for Joe Sixpack trying to put together the bootleg epi kit at his local pharmacy.
Knowledge of drug delivery/storage isn't exactly in Joe sixpack's wheelhouse.
View Quote View All Quotes
View All Quotes
Discussion ForumsJump to Quoted PostQuote History
Quoted:
Quoted:
Quoted:
Quoted:
OP is an expired epi pen really not usable?


The answer is depends.
Epinephrine isn't particularly stable and exposure to high heat or UV light can very quickly degrade it to the point that it is completely ineffective.
The manufactures expiration date is based on stability studies within their prescribed storage conditions with a bit of a buffer.
Best course of action is to have an in date pen or ampule and store it appropriately and rotate it out of service when expired.

And whoever is recommending pre-drawing up the syringes STOP!.  Sterility concerns aside drawing epi up in a standard plastipak syringe will degrade to useless in a matter of days.


So use glass syringes.


That's an option but 99.99% of the 1ml syringes available on the market are going to be 1ml slip tip or luer plastic TB syringes. Very few glass small volume syringes out there and most of those are for specialty use. Good luck for Joe Sixpack trying to put together the bootleg epi kit at his local pharmacy.
Knowledge of drug delivery/storage isn't exactly in Joe sixpack's wheelhouse.


Kind of why I was wondering if there were 1mg/ml vials.  Drawing out of an ampule could be very difficult for someone who isn't practiced.  Drawing from a vial would be considerably easier with less chance someone who doesn't draw up meds from ampules regularly doesn't slice up their fingers.

Posted Via AR15.Com Mobile
Link Posted: 8/26/2016 12:36:31 AM EDT
[#18]
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Quoted:
You would be mind boggled at the number of auto injectors the military has to dispose of every month because they are expired.

Just imagine the money that gets flushed down the drain.
View Quote

AKA the cost of readiness.
Link Posted: 8/26/2016 12:59:59 AM EDT
[#19]
Holy shit the clowns still falling over themselves to defend this as "capitalism" all because in their little minds, ANY criticism of ANY business for ANY reason is tantamount to being a liberal socialist communist.

They try to sound so smart with their tired bullshit rhetoric of "their business their rules" or "start your own company" without reading any of the articles or facts pertaining to this particular case, and shout down anyone who is critical of what going on. The funniest part? They're defending a piece of fucking shit democrat clinton donor engaging in blatant cronyism but have the unmitigated gall to chastise those who are calling this what it is.

I said earlier I love threads like this because they're awesome for a laugh, and I sure have not been disappointed.
Link Posted: 8/26/2016 1:08:16 AM EDT
[#20]
They are basically defending corruption. As my free market economics professor friend of mine would say -- "They don't know economics"..
Link Posted: 8/26/2016 1:11:00 AM EDT
[#21]
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You know how I know you didn't read the thread or any links...  
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Quoted:
Did I just stumble into the DU?

This is capitalism. Deal with it.

They can charge what they like. Another company is free to create an alternative that costs less and corners the market.


You know how I know you didn't read the thread or any links...  


Well at least he chose his user name wisely.
Link Posted: 8/26/2016 7:26:19 AM EDT
[#22]
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Quoted:
anyone calling this capitalism is a flat out moron.

Government mandated "Must buy EpiPen" from Congress
Government granted monopoly (FDA won't approve other competitors)
Government funded this being created

Yeah, totes free market bros
View Quote



And how many Senators bought stock and got in on the ground floor just before the price increase?      


Cocksuckers the whole bunch of 'em.  

This is how they all become rich while in office.
Link Posted: 8/26/2016 7:28:36 AM EDT
[#23]
http://video.foxbusiness.com/v/5099028384001/paid-spokeswoman-for-mylan-quits-calls-for-ceo-to-resign/?#sp=show-clips

Go to the link and watch this video. Each Epi-Pen costs a $1 to make according to the former Mylan Spokesman.
Link Posted: 8/26/2016 7:35:43 AM EDT
[#24]
Discussion ForumsJump to Quoted PostQuote History
Quoted:
http://video.foxbusiness.com/v/5099028384001/paid-spokeswoman-for-mylan-quits-calls-for-ceo-to-resign/?#sp=show-clips

Go to the link and watch this video. Each Epi-Pen costs a $1 to make according to the former Mylan Spokesman.
View Quote

So what?

What does it cost to make an iPhone?

Link Posted: 8/26/2016 7:41:22 AM EDT
[#25]
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Quoted:

So what?

What does it cost to make an iPhone?

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Quoted:
http://video.foxbusiness.com/v/5099028384001/paid-spokeswoman-for-mylan-quits-calls-for-ceo-to-resign/?#sp=show-clips

Go to the link and watch this video. Each Epi-Pen costs a $1 to make according to the former Mylan Spokesman.

So what?

What does it cost to make an iPhone?



Does the government require Iphones in schools, is the government trying to require an Iphone be provided to the passengers on a plane at the Airlines expense, is Iphone being assisted by the government forcing competitor products off the market and preventing more from coming to the market? Will you die without access to an Iphone? Is the CEO of Apple the son of a powerful US Senator who as governor saw his son get a college degree he was unqualified to receive?

Corruption and Cronyism is among the reason this is happening.
Link Posted: 8/26/2016 8:01:22 AM EDT
[#26]

Discussion ForumsJump to Quoted PostQuote History
Quoted:


Holy shit the clowns still falling over themselves to defend this as "capitalism" all because in their little minds, ANY criticism of ANY business for ANY reason is tantamount to being a liberal socialist communist.



They try to sound so smart with their tired bullshit rhetoric of "their business their rules" or "start your own company" without reading any of the articles or facts pertaining to this particular case, and shout down anyone who is critical of what going on. The funniest part? They're defending a piece of fucking shit democrat clinton donor engaging in blatant cronyism but have the unmitigated gall to chastise those who are calling this what it is.



I said earlier I love threads like this because they're awesome for a laugh, and I sure have not been disappointed.
View Quote


Not saying you're wrong, but getting $300 for a pen is going to open the market up to many manufacturers, thereby increasing competition, which will eventually stabilize the price at a lower point.



 
Link Posted: 8/26/2016 8:32:18 AM EDT
[#27]
Discussion ForumsJump to Quoted PostQuote History
Quoted:

Not saying you're wrong, but getting $300 for a pen is going to open the market up to many manufacturers, thereby increasing competition, which will eventually stabilize the price at a lower point.
 
View Quote View All Quotes
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Discussion ForumsJump to Quoted PostQuote History
Quoted:
Quoted:
Holy shit the clowns still falling over themselves to defend this as "capitalism" all because in their little minds, ANY criticism of ANY business for ANY reason is tantamount to being a liberal socialist communist.

They try to sound so smart with their tired bullshit rhetoric of "their business their rules" or "start your own company" without reading any of the articles or facts pertaining to this particular case, and shout down anyone who is critical of what going on. The funniest part? They're defending a piece of fucking shit democrat clinton donor engaging in blatant cronyism but have the unmitigated gall to chastise those who are calling this what it is.

I said earlier I love threads like this because they're awesome for a laugh, and I sure have not been disappointed.

Not saying you're wrong, but getting $300 for a pen is going to open the market up to many manufacturers, thereby increasing competition, which will eventually stabilize the price at a lower point.
 

I don't think you quite understand how a monopoly works, For one thing, Mylan holds a patent on it. Mylan therefore exploits this. Also, the FDA is also responsible for letting Mylan keep their monopoly, they just denied an Israeli company from FDA approval with a generic version of the epipen.
Link Posted: 8/26/2016 8:33:57 AM EDT
[#28]

Discussion ForumsJump to Quoted PostQuote History
Quoted:

I don't think you quite understand how a monopoly works, For one thing, Mylan holds a patent on it. Mylan therefore exploits this. Also, the FDA is also letting responsible for letting Mylar keep their monopoly they just denied an Israeli company from FDA approval with a generic version of the epipen.
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Do you know for a fact the company still holds a patent on the original, government ordered design, rather than the newer types they make now?



 
Link Posted: 8/26/2016 8:40:31 AM EDT
[#29]
Discussion ForumsJump to Quoted PostQuote History
Quoted:

Do you know for a fact the company still holds a patent on the original, government ordered design, rather than the newer types they make now?
 
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Discussion ForumsJump to Quoted PostQuote History
Quoted:
Quoted:
I don't think you quite understand how a monopoly works, For one thing, Mylan holds a patent on it. Mylan therefore exploits this. Also, the FDA is also letting responsible for letting Mylar keep their monopoly they just denied an Israeli company from FDA approval with a generic version of the epipen.

Do you know for a fact the company still holds a patent on the original, government ordered design, rather than the newer types they make now?
 

I'm sure the 70's design is probably different than the one they have on the market now. If you were to make any new updates to a product wouldn't you also file a patent to protect the new version?
Link Posted: 8/26/2016 8:44:47 AM EDT
[#30]

Discussion ForumsJump to Quoted PostQuote History
Quoted:





I'm sure the 70's design is probably different than the one they have on the market now. If you were to make any new updates to a product wouldn't you also file a patent to protect the new version?
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Quoted:



Quoted:


Quoted:

I don't think you quite understand how a monopoly works, For one thing, Mylan holds a patent on it. Mylan therefore exploits this. Also, the FDA is also letting responsible for letting Mylar keep their monopoly they just denied an Israeli company from FDA approval with a generic version of the epipen.


Do you know for a fact the company still holds a patent on the original, government ordered design, rather than the newer types they make now?

 


I'm sure the 70's design is probably different than the one they have on the market now. If you were to make any new updates to a product wouldn't you also file a patent to protect the new version?
To your question, sure.  But if the patent expired (or never existed since it was government work) for the original design, what is stopping another company from making the original design again?



And while we are at it, do you know that the Israeli company was blocked for cronyism reasons rather than manufacturing deficiencies like the FDA said?



 
Link Posted: 8/26/2016 8:55:56 AM EDT
[#31]
Discussion ForumsJump to Quoted PostQuote History
Quoted:
To your question, sure.  But if the patent expired (or never existed since it was government work) for the original design, what is stopping another company from making the original design again?

And while we are at it, do you know that the Israeli company was blocked for cronyism reasons rather than manufacturing deficiencies like the FDA said?
 
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Quoted:
Quoted:
Quoted:
Quoted:
I don't think you quite understand how a monopoly works, For one thing, Mylan holds a patent on it. Mylan therefore exploits this. Also, the FDA is also letting responsible for letting Mylar keep their monopoly they just denied an Israeli company from FDA approval with a generic version of the epipen.

Do you know for a fact the company still holds a patent on the original, government ordered design, rather than the newer types they make now?
 

I'm sure the 70's design is probably different than the one they have on the market now. If you were to make any new updates to a product wouldn't you also file a patent to protect the new version?
To your question, sure.  But if the patent expired (or never existed since it was government work) for the original design, what is stopping another company from making the original design again?

And while we are at it, do you know that the Israeli company was blocked for cronyism reasons rather than manufacturing deficiencies like the FDA said?
 
Autoinjector design has changed over the years, the current designs cover the needle as it is withdrawn from the patient vs the prior ones leaving it exposed. Thus how the current design is patent protected.

Then you have the testing to show the dose is consistent, which is not cheap or easy.

Kharn

Posted Via AR15.Com Mobile
Link Posted: 8/26/2016 9:00:21 AM EDT
[#32]
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Quoted:
To your question, sure.  But if the patent expired (or never existed since it was government work) for the original design, what is stopping another company from making the original design again?

And while we are at it, do you know that the Israeli company was blocked for cronyism reasons rather than manufacturing deficiencies like the FDA said?
 
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Quoted:
Quoted:
Quoted:
Quoted:
I don't think you quite understand how a monopoly works, For one thing, Mylan holds a patent on it. Mylan therefore exploits this. Also, the FDA is also letting responsible for letting Mylar keep their monopoly they just denied an Israeli company from FDA approval with a generic version of the epipen.

Do you know for a fact the company still holds a patent on the original, government ordered design, rather than the newer types they make now?
 

I'm sure the 70's design is probably different than the one they have on the market now. If you were to make any new updates to a product wouldn't you also file a patent to protect the new version?
To your question, sure.  But if the patent expired (or never existed since it was government work) for the original design, what is stopping another company from making the original design again?

And while we are at it, do you know that the Israeli company was blocked for cronyism reasons rather than manufacturing deficiencies like the FDA said?
 


Somehow I don't buy the fact that only this one company has the skills to put a 100 year old drug in an injector, FDA is protecting us from these companies and people should be grateful to pay $600 for something that costs a dollar or two to produce with no real development cost.
Link Posted: 8/26/2016 9:14:59 AM EDT
[#33]
Patents don't really play a role here at all. What we have is the FDA protecting the brand owned by aDemocrat Senators daughter.

Teva Pharmaceuticals had their design rejected outright for deficiencies:
Discussion ForumsJump to Quoted PostQuote History
Teva received a complete response letter on February 23 relating to its epinephrine ANDA in which the FDA identified certain major deficiencies. Teva is evaluating the CRL and intends to submit a response. Due to the major nature of the CRL, Teva expects that its epinephrine product will be significantly delayed and that any launch will not take place before 2017.
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Teva received a complete response letter on February 23 relating to its epinephrine ANDA in which the FDA identified certain major deficiencies. Teva is evaluating the CRL and intends to submit a response. Due to the major nature of the CRL, Teva expects that its epinephrine product will be significantly delayed and that any launch will not take place before 2017.

Sanofi was forced to recall its Auvi-Q autoinjectors because of 26 unconfirmed reports of the injector dispensing inaccurate dosages. There were 2.8 million Auvi-Q injectors in the wild, but the recall came down from the FDA over unconfirmed reports.

From the rep at Sanofi:
We have no evidence to date of the device malfunction. Of the cases reported of device malfunctions – of all the ones that were sent back – we were not actually able to see the device malfunction. So the basis of the recall is for the potential of an inaccurate dosage. Also, that’s 26 cases reported out of 2.8 million units in North America since the launch of Auvi-Q in the U.S. and Allerject in Canada in January 2013.

Oddly enough, it seems the FDA is clearing out the competition just in time for the passage of bills requiring or encouraging schools to stock epinephrine auto-injectors as well as a bill to require airlines to keep a number of autoinjectors on board each of their aircraft. That bill can be found in the Senate Committee on Commerce, Science, and Transportation- Joe Manchin is a member.

Finally, real world tests show that correct dosage administration and proper use by consumers of Epi Pens as they're designed runs around 45%. The FDA rejected the Auvi-Q for a supposed, unconfirmed failure or mis-dosage rate of a fraction of a percent: 0.0001% of their units "failed."

Something stinks IMHO.
Link Posted: 8/26/2016 9:21:13 AM EDT
[#34]
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Quoted:


Sounds exactly like capitalism to me.  It's using the tools available to it to extract money from people.
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No how I know you didn't read, either?

It's NOT capitalism when you pay off the gov to kneecap your competition so you have a monopoly on a drug you didn't spend any money creating and a device developed by the gov.


Sounds exactly like capitalism to me.  It's using the tools available to it to extract money from people.





Capitalism:
an economic and political system in which a country's trade and industry are controlled by private owners for profit, rather than by the state.
Link Posted: 8/26/2016 9:29:38 AM EDT
[#35]
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Quoted:
Somehow I don't buy the fact that only this one company has the skills to put a 100 year old drug in an injector, FDA is protecting us from these companies and people should be grateful to pay $600 for something that costs a dollar or two to produce with no real development cost.
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So you don't know...but you feel that there's collusion.  How progressive of you.
Link Posted: 8/26/2016 9:40:04 AM EDT
[#36]
Link Posted: 8/26/2016 9:42:17 AM EDT
[#37]
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Quoted:


So you don't know...but you feel that there's collusion.  How progressive of you.
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Somehow I don't buy the fact that only this one company has the skills to put a 100 year old drug in an injector, FDA is protecting us from these companies and people should be grateful to pay $600 for something that costs a dollar or two to produce with no real development cost.


So you don't know...but you feel that there's collusion.  How progressive of you.


You could buy a 3D printer for $600 and make this thing at home then buy new vials when they expire.  

Link Posted: 8/26/2016 9:44:54 AM EDT
[#38]
The government should tax them.  That'll fix it.
Link Posted: 8/26/2016 9:51:18 AM EDT
[#39]
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She gave you lies, I gave you the facts. Choosing not to believe it is your problem.

Hmmm. She says 55% of the drug is because of other people to the public after public outcry. But a call to investors this very month says they (Mylan) charge wholesalers just under $600 for it.  


Just to be sure, I checked with our pharmacy distributor (I work for a company that buys from them). What Mylan charges them for EpiPen supports my claim.


Mylan is the sole driver for the costs.
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CNBC and the CEO of Mylan just explained that 55% of the price of an EpiPen is added by entities other than* Mylan.
 
$274+$334=$608.

So let's go after Mylan.

* Pharmacy Benefit Managers, wholesalers/distributors, etc.
Her excuse is BS. 55% of that price is not added by others outside of Mylan. She's lying and stupid since it is easily debunked.

WAC=wholesale acquisition cost (aka-Mylan's price for the drug to wholesalers and distributor)  

http://www.post-gazette.com/business/healthcare-business/2016/08/24/EpiPen-pricing-fuels-new-debate-over-drug-pricing/stories/201608240069

During the company’s Aug. 9 earnings call, Mylan CEO Heather Bresch defended the EpiPen’s pricing, saying, "If you look on an annual basis, as a lifesaving drug, to have a WAC [wholesale acquisition cost] price at just under $600, I think that you can see it falls as not an expensive product.”





You can believe whatever you want about the evil biotechs and the greedy CEOs...facts are fact.

If you want to go after the biggest cost drivers in the EpiPen, Mylan isn't the place to start.
She gave you lies, I gave you the facts. Choosing not to believe it is your problem.

Hmmm. She says 55% of the drug is because of other people to the public after public outcry. But a call to investors this very month says they (Mylan) charge wholesalers just under $600 for it.  


Just to be sure, I checked with our pharmacy distributor (I work for a company that buys from them). What Mylan charges them for EpiPen supports my claim.


Mylan is the sole driver for the costs.


You should call CNN or MSNBC with your new facts...seems you've scooped all of the news and financial channels with your in depth investigative reporting.

Go for it!!!

Set things right, SJW!!!
Link Posted: 8/26/2016 9:51:24 AM EDT
[#40]
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Quoted:


Well.  There you have it.

There's certainly to reason to suspect collusion and corruption from THIS bunch.... you crazy wingnuts better rekonize!
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Somehow I don't buy the fact that only this one company has the skills to put a 100 year old drug in an injector, FDA is protecting us from these companies and people should be grateful to pay $600 for something that costs a dollar or two to produce with no real development cost.


So you don't know...but you feel that there's collusion.  How progressive of you.


Well.  There you have it.

There's certainly to reason to suspect collusion and corruption from THIS bunch.... you crazy wingnuts better rekonize!

Suspect?  Sure.

Investigate?  Absolutely

Get out the pitchforks and start demanding the government fix the pricing?  No.
Link Posted: 8/26/2016 9:52:37 AM EDT
[#41]
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Quoted:

Suspect?  Sure.

Investigate?  Absolutely

Get out the pitchforks and start demanding the government fix the pricing?  No.
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Somehow I don't buy the fact that only this one company has the skills to put a 100 year old drug in an injector, FDA is protecting us from these companies and people should be grateful to pay $600 for something that costs a dollar or two to produce with no real development cost.


So you don't know...but you feel that there's collusion.  How progressive of you.


Well.  There you have it.

There's certainly to reason to suspect collusion and corruption from THIS bunch.... you crazy wingnuts better rekonize!

Suspect?  Sure.

Investigate?  Absolutely

Get out the pitchforks and start demanding the government fix the pricing?  No.

Agreed. Especially the investigate.
Link Posted: 8/26/2016 10:30:56 AM EDT
[#42]
While not to defend Mylan, all those saying that schools are being required to pay for the epipens are not entirely true.  Mylan has a program called EpiPen For Schools (look it up if you don't believe me) where schools can get pens for free. They are actively lobbying to get the pens in the schools are doing so on the state level, but to date they have given away over 500k pens free to schools who participate in the program.  As for the airlines, I'm sure the private companies would be required to pay for them.


I know this because I used to work for Mylan.  The price of the EpiPen is honestly one of the main reasons I no longer work there.  It is their business and well within their rights to charge however much they want for it, but I was personally disturbed by this and want to work somewhere else.  While Mylan is somewhat truthful that they can't control the costs from the distributor level to the individual pharmacy, they are also having a major impact on the drug cost.  Anyone who thinks they margins for the wholesaler and the end seller (pharmacy) have not also risen during this time is wrong.  


I heard a sales manager tell a customer once that the price of epipens has only risen by $17 over 5 years from what Mylan sells to the distributor.  I personally don't believe that, but I do know that Mylan is spending money like a drunken sailor to get rebates and favorable second tier coverage for patients with insurance.  I think I read that for patient's not on a high deductible plan, EpiPen has like a 95% second tier coverage rate (lowest branded copay and the next level above generics).  The reason this pricing has come to light is the popularity of the high deductible plans from the insurance companies.  Those plans offer monthly premium cost savings to the patient, but they are no longer shielded from the true cost of the medications being prescribed.  Mylan was constantly getting feedback from doctors and pharmacies to do a better job on helping the cash pay (high deductible patient).  The one good thing about the high deductible plans is the realization by many of just how expensive their healthcare has become and are hopefully becoming wiser in their decisions for medical care.  A relatively new asthma medication costs approx $390 per month for cash pay patients yet if you have insurance with traditional copays you won't see this cost.  It is the cash pay patient that now realizes this cost and will then start to seek other options for generic treatments that are similar in clinical outcomes.  Take that almost $400 a month for a year ($4800) in contrast to $700 yearly cost of the epipen ($60 a month averaged out).  Oh, and yes their is a generic available called adrenaclick (it uses at slightly different delivery mechanism, so legally pharmacies can't directly switch if the script says EpiPen) but they can get them for approx $150 for a 2 pack


Once again, I am not truly defending Mylan as I stated, this very reason weighed heavy on my decision to leave.

Link Posted: 8/26/2016 10:35:37 AM EDT
[#43]
The gov picks it's favorites. Fda is blocking competitors, I doubt it's because they have serious deficiencies.
Link Posted: 8/26/2016 10:50:53 AM EDT
[#44]
Link Posted: 8/26/2016 11:05:46 AM EDT
[#45]
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Bait and switch. Our township board used to vote on their own salaries. They'd have friends shill a high raise so they could say that was too much. So the shills would say half the raise would be good.
The board would "reluctantly" say ok and vote themselves the money they'd decided they wanted but it would look good in the local paper to residents who weren't real bright.
Link Posted: 8/26/2016 11:20:17 AM EDT
[#46]
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FWIW- I carry an epi-pen everywhere I go due to an allergic condition. The last set I purchased was about three years ago, so I believe they are coming up on their expiration. I have no idea how much they will cost me. Whatever it is, I will pay it.

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Might want to check on that expiration thing. Mine are good for one year unless the medication is cloudy. Pull the auto injector out of the case and you'll see a little window to check the color. You may not be safe with the ones you have.
Link Posted: 8/26/2016 11:36:58 AM EDT
[#47]
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If you don't think it's worth it, don't buy it.
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Link Posted: 8/26/2016 11:43:38 AM EDT
[#48]
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Not saying you're wrong, but getting $300 for a pen is going to open the market up to many manufacturers, thereby increasing competition, which will eventually stabilize the price at a lower point.
 
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Holy shit the clowns still falling over themselves to defend this as "capitalism" all because in their little minds, ANY criticism of ANY business for ANY reason is tantamount to being a liberal socialist communist.

They try to sound so smart with their tired bullshit rhetoric of "their business their rules" or "start your own company" without reading any of the articles or facts pertainin byg to this particular case, and shout down anyone who is critical of what going on. The funniest part? They're defending a piece of fucking shit democrat clinton donor engaging in blatant cronyism but have the unmitigated gall to chastise those who are calling this what it is.

I said earlier I love threads like this because they're awesome for a laugh, and I sure have not been disappointed.

Not saying you're wrong, but getting $300 for a pen is going to open the market up to many manufacturers, thereby increasing competition, which will eventually stabilize the price at a lower point.
 


Assumes FDA does not continue the cock blocking of new epinephrine injectors coming to market.
Link Posted: 8/26/2016 11:48:10 AM EDT
[#49]
Manufacturer offering a discount card (up to 50% off) based on publicity, apparently.

click
Link Posted: 8/26/2016 11:50:50 AM EDT
[#50]
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Quoted:


Sounds exactly like capitalism to me.  It's using the tools available to it to extract money from people.
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No how I know you didn't read, either?

It's NOT capitalism when you pay off the gov to kneecap your competition so you have a monopoly on a drug you didn't spend any money creating and a device developed by the gov.


Sounds exactly like capitalism to me.  It's using the tools available to it to extract money from people.


No, it's not capitalism.  It's fascism.  Not postulating Godwin's law here.  Real fascism.  Socialism with semi-centralized planning via state and business partnership. Those with polticial power working the authority of the state to distribute economic power to a politically aligned cadre of owners.  It utterly corrupts the economic system.  It's probably the most insidious form of tyranny because it's truly boiling the frog by slowly heating the pot.

The reason for the price hike here is not that the company wanted to turn the screw to all their customers to see what the market could bear - It was that the company was given a near government monopoly through carefully crafted legislation.  The crux is that when you sell to the fed they get most favored pricing - meaning that you cannot sell to someone else for a lower price.  If the majority of your sales were on the commercial side, you would have to stay competitive, BUT when you are granted a government contract that guarantees more sales to government than you will get in private side sales, the pricing is not based on a supply/demand curve but on whatever "profit" cover your political backers can swing for you.  In this case they had a perfect storm of backing.  That is not capitalism.  It is not free or even semi-free market economics.  It is fascism.    
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