Epi

[mnholdem]

Source: money.cnn.com/2016/09/06/news/companies/mylan-schneiderman-investigation/

Mylan's program to distribute its troubled EpiPens in schools are drawing antitrust allegations.
by Jackie Wattles @jackiewattles
September 6, 2016: 2:57 PM ET 

Excerpt:

 
Senators Richard Blumenthal and Amy Klobuchar asked the Federal Trade Commission Tuesday to look into whether the company took illegal steps "to protect its EpiPen product from competition." 

"As the cost of EpiPens skyrocketed, schools seeking relief turned to Mylan's 'EpiPen4Schools' program, which offered a significant discount for the lifesaving drug," a statement from the senators reads. "Some of these schools were required to sign a contract agreeing not to purchase any products from Mylan's competitors for a period of 12 months."

[lakers]

Epinephrine Improves the Efficacy of Nebulized Hypertonic Saline in Moderate Bronchiolitis: A Randomised Clinical Trial

journals.plos.org/plosone/article?id=10.1371%2Fjournal.pone.0142847

[lakers]

U.S. government health plans spent over $1 billion on EpiPens over five years

www.reuters.com/article/us-mylan-epipen-cms-idUSKCN1252S7

By Bill Berkrot

U.S. government health plans spent more than $1 billion on Mylan NV's EpiPen emergency allergic reaction treatment between 2011 and 2015, according to figures released by the Centers for Medicare and Medicaid Services on Wednesday.

Mylan is under scrutiny for raising prices on the lifesaving EpiPen sixfold in less than a decade, making the devices unaffordable for a growing number of families. U.S. lawmakers and prosecutors are also investigating what impact Mylan's EpiPen pricing has had on government-funded health programs.

CMS, in response to a request from U.S. Senator Amy Klobuchar of Minnesota, said in a letter that the Medicaid plan for the poor spent $797 million on EpiPen in the five-year period, including rebates provided by Mylan, or $960 million before rebates. Costs for the Medicare Part D program for the elderly was nearly $335 million, a figure that does not reflect rebates.

Klobuchar and other lawmakers contend that Mylan underpaid rebates to state Medicaid programs by misclassifying EpiPen as a generic instead of a branded drug. The Medicaid rebate for a generic is 13 percent compared with a minimum 23.1 percent for a branded drug.

CMS said it could not determine how much the government is owed for EpiPens, but reiterated its view that Mylan had misclassified the product.

"CMS has, on multiple occasions, provided guidance to the industry and Mylan on the proper classification of drugs and has expressly told Mylan that the product is incorrectly classified," the agency said.

Mylan has said it complied with CMS rules. On Wednesday, it noted that the classification of EpiPen for Medicaid rebates had been made in 1997, a decade before it acquired the product.

New CMS rules that took effect this year allow companies to clarify any classification issues for a product like EpiPen, with companies asked to submit their requests by April 1, 2017.

"It would be premature to comment further on this issue until the CMS process has concluded," Mylan said.

Klobuchar in a statement called for "clear answers on how deep this misclassification goes, how much it has cost taxpayers across the country, how many other drugs may be misclassified, and how we get that money back."Mylan Chief Executive Heather Bresch was blasted by lawmakers during a congressional hearing last month for raising the list price for a pair of EpiPens to more than $600 this year. It cost about $100 in 2007, when Mylan acquired the product.

[Deleted]

Oct 4, 2016 21:57:39 GMT -5 beardawg said:

Oct 2, 2016 21:57:04 GMT -5 mango said:

I'll make it very simplistic for you:

—Sheldon Kaplan was the main inventor of the ComboPen, which is what is also known as the EpiPen

—The ComboPen, the original EpiPen, which was used by the military for years before it ever even became approved by the FDA was sought for because the DoD needed a simple solution for their soldiers to use against nerve gas. The FDA approved the EpiPen for marketing to consumers back in……...wait for it……..1987 (same year I was born)
—Kaplan’s original patent was granted in 1977. The military sought after Kaplan’s invention in 1973 when he worked with Survival Technology, Inc. after leaving NASA.
This is the original patent:
•Hypodermic injection device having means for varying the medicament capacity thereof
patents.justia.com/patent/4031893


—So, just so you are aware, this was all originally funded via taxpayer money once the military got their hands on it. 
Being used by the military and being funded by taxpayer money are two different things. From what I've read, it sounds like the wouldn't have received a dime if they didn't come up with the injector. That the military used it is of no consequence. Should we also get free/cheap guns and knives from companies that sell guns and knives to the military (at the behest of the military)?
—There was virtually no risk on Mylan’s part acquiring the rights to market EpiPen from Merck Generics back in 2007 in a deal that costed Mylan $6.7 billion, and included more than just the EpiPen. Also, Mylan does not manufacture the EpiPen. King Pharmaceuticals does, which is also owned by non other than…….Pfizer.
newsroom.mylan.com/press-releases?item=122513
Yes, there was risk. They paid money to market it. If they couldn't increase sales, they would lose out on the deal.

—You see, your claim: “Though it is overpriced, the cost of the Epipen includes more than just the manufacturing cost. It includes everything it took to research, create, and go through FDA approval, along with the risks the company took that it wouldn't get approved (and the wasted money it could had), and advertising.”

—Is completely false. Mylan does NOT manufacture EpiPen, King Pharmaceuticals which is owned by Pfizer does. Mylan also did NOT research, create, go through the FDA, did not take any risks to go through the FDA because it was ALREADY approved in 1987. Mylan did absolutely NONE of those things, except marketing, which brings me to this corruption:
The fact that they don't actually make it is irrelevant. King Pharma doesn't make it for free; there is a cost associated with that. The total cost/profit is split between all of the companies, though I'm sure Mylan profits the most. Just like Sanofi "marketed" for MannKind, MannKind has costs associated with creating/manufacturing Afrezza, so they even charged it to the partnership. Sanofi didn't create anything, but they would have handsomely benefited from the sale of Afrezza. It's no different than Walmart selling a product. They didn't make it at all; that doesn't mean they don't include in the price the cost to make it.


—In 2012, Mylan launched a program called EpiPen4Schools to sell EpiPen to schools. Obama, your POTUS, signed this into LAW, requiring any school that has students with food allergies to buy EpiPen. Also, the schools had to agree not to buy epinephrine auto injectors from any other company for at least a year.
I agree, corrupt in how they got into schools. If they didn't do it that way, but it just came about naturally, I wouldn't have a problem with it. It's a helpful thing, no different than requiring healthy food or certain cleaning products or something.

—Since 2012 Mylan had gone from increasing the price of EpiPen: $200 to over $600 
Excessive, yes. But how do you decide the cost? I can't say it's always the best way, but competition is a good way. If others can't make it, it shows how much they had to do to come up with it. If it was simple, everyone would get into it successfully. And the whole point of a patent is the reward the company for the work they put in so that they can benefit exclusively from that work for a set time. it's a short term monopoly to encourage innovation. Innovate and you will be rewarded. If still no one can come up with an alternative after the patent expires, you then survive on the merit of the complexity of the invention itself.

—If you think you can claim BS you are wrong. I didn't even add all the other facts about US senators being involved and the monopoly Pfizer and Mylan have created.

—You think Urbanski left Mylan because he didn't want to be associated with this corruption? I do. you are either getting your info from a moron or you are here to create disinformation.
I highly doubt that. they had been raising the prices for years before he left.

See comments above in blue.

Again, I AGREE that the Epipen is overpriced. My gripe is with the misleading "it only costs a dollar to make" argument. 

• Being used by the military and being funded by taxpayer money are two different things. From what I've read, it sounds like the wouldn't have received a dime if they didn't come up with the injector. That the military used it is of no consequence. Should we also get free/cheap guns and knives from companies that sell guns and knives to the military (at the behest of the military)?

— Who wouldn’t receive a dime if who wouldn’t have come up with the autoinjector?
Mylan did not invent the autoinjector. Sheldon Kaplan did. Who do you think paid Kaplan to finish the ComboPen so the military could begin immediately using it? Survival Technology, Inc.? No. The DoD? Yes. How is the government funded?  
I never said we should get anything for free. Where did I say that?

• Yes, there was risk. They paid money to market it. If they couldn't increase sales, they would lose out on the deal.

—Mylan acquired Merck Generics, not just EpiPen. Merck Generics had sales in over 90 countries and was the 3rd world largest generics company when Mylan acquired Merck Generics. You seriously believe that Mylan had to raise the price of EpiPen to make back the cash deal they did? No. Mylan only recognized the monopoly that they could have with EpiPen. You act as if EpiPen is the only source of revenue for Mylan. They bought the world’s 3rd largest generics company, and you are trying to make it out as if the entire deal weighs on the balance of EpiPen’s success, which is ridiculous.

• The fact that they don't actually make it is irrelevant. King Pharma doesn't make it for free; there is a cost associated with that. The total cost/profit is split between all of the companies, though I'm sure Mylan profits the most. Just like Sanofi "marketed" for MannKind, MannKind has costs associated with creating/manufacturing Afrezza, so they even charged it to the partnership. Sanofi didn't create anything, but they would have handsomely benefited from the sale of Afrezza. It's no different than Walmart selling a product. They didn't make it at all; that doesn't mean they don't include in the price the cost to make it.

— I believe what you originally said was: “Though it is overpriced, the cost of the Epipen includes more than just the manufacturing cost. It includes everything it took to research, create, and go through FDA approval, along with the risks the company took that it wouldn't get approved (and the wasted money it could had), and advertising.”

— Again, Mylan never did any research to make EpiPen, Mylan never created the EpiPen, and Mylan never took the EpiPen through the FDA. So how would Mylan be able to have all the risks that it wouldn’t get approved, as you claimed above, if they never did any of those things?  

• Excessive, yes. But how do you decide the cost? I can't say it's always the best way, but competition is a good way. If others can't make it, it shows how much they had to do to come up with it. If it was simple, everyone would get into it successfully. And the whole point of a patent is the reward the company for the work they put in so that they can benefit exclusively from that work for a set time. it's a short term monopoly to encourage innovation. Innovate and you will be rewarded. If still no one can come up with an alternative after the patent expires, you then survive on the merit of the complexity of the invention itself.

— Again, Mylan did not “come up” with the EpiPen. Mylan did not create the EpiPen. Others actually can and have made alternatives. Amedra Pharmaceuticals has Adrenaclick, Impax Laboratories has a generic version of Adrenaclick, Teva is is trying to make a generic EpiPen, and MannKind is making an inhaled epinephrine. Patent for an auto injector doesn’t mean a company can’t make an alternative auto injector or even a completely different alternative like what MannKind is doing.

• highly doubt that. they had been raising the prices for years before he left.

— So, you think he quit Mylan just for the heck of it? Not because they are corrupt? Solely to start LNR BioPharma Consulting? He joined MannKind just two years after leaving Mylan. After he joined MannKind in September 2015, how soon after was it we started hearing about inhaled epi? January was it? What month did we hear about RLS? 

[mnkdfann]

Oct 5, 2016 8:18:17 GMT -5 mnholdem said:

Source: money.cnn.com/2016/09/06/news/companies/mylan-schneiderman-investigation/

Mylan's program to distribute its troubled EpiPens in schools are drawing antitrust allegations.
by Jackie Wattles @jackiewattles
September 6, 2016: 2:57 PM ET 

Excerpt:

 
Senators Richard Blumenthal and Amy Klobuchar asked the Federal Trade Commission Tuesday to look into whether the company took illegal steps "to protect its EpiPen product from competition." 

"As the cost of EpiPens skyrocketed, schools seeking relief turned to Mylan's 'EpiPen4Schools' program, which offered a significant discount for the lifesaving drug," a statement from the senators reads. "Some of these schools were required to sign a contract agreeing not to purchase any products from Mylan's competitors for a period of 12 months."

And a little later in the same article (where it discusses facts versus the above unsubstantiated allegations from two politicians):

"Mylan's EpiPen4Schools program gives free injectors to about 65,000 schools nationwide, and the company issued a statement Tuesday denying the claims its contracts included non-compete agreements."

[Deleted]

Oct 6, 2016 11:02:11 GMT -5 mnkdfann said:

Oct 5, 2016 8:18:17 GMT -5 mnholdem said:

Source: money.cnn.com/2016/09/06/news/companies/mylan-schneiderman-investigation/

Mylan's program to distribute its troubled EpiPens in schools are drawing antitrust allegations.
by Jackie Wattles @jackiewattles
September 6, 2016: 2:57 PM ET 

Excerpt:

 
Senators Richard Blumenthal and Amy Klobuchar asked the Federal Trade Commission Tuesday to look into whether the company took illegal steps "to protect its EpiPen product from competition." 

"As the cost of EpiPens skyrocketed, schools seeking relief turned to Mylan's 'EpiPen4Schools' program, which offered a significant discount for the lifesaving drug," a statement from the senators reads. "Some of these schools were required to sign a contract agreeing not to purchase any products from Mylan's competitors for a period of 12 months."

And a little later in the same article (where it discusses facts versus the above unsubstantiated allegations from two politicians):

"Mylan's EpiPen4Schools program gives free injectors to about 65,000 schools nationwide, and the company issued a statement Tuesday denying the claims its contracts included non-compete agreements."

•Mylan will only provide 4 EpiPen® or EpiPen Jr® Auto-Injectors or a 2 pack of each.
—Of course, there is also this law that helps Mylan quite a bit:
“Section 504 of the Rehabilitation Act of 1973 and the Americans with Disabilities Act of 1990 (ADA) are major pieces of federal legislation designed to protect the civil rights of individuals with disabilities.8-10 They define a disability as “an impairment that limits a major life activity.”10-12 In food allergies, three major life activities—eating, breathing, and caring for self—could be affected.10,11
Parents of children with potentially life-threatening allergies have the right to request a 504 Plan for their child’s school to document how teachers and other staff will address trigger avoidance and anaphylaxis treatment.8,9”


•Gayle Manchin

—The mother of Mylan CEO, Heather Bresch.
—Gayle Manchin was the president of the National Association of State Boards of Education when Bresch became CEO of Mylan in 2012. Ironically, soon after Bresch became CEO of Mylan, and just four month after the launch of EpiPen4Schools (August 2012), which later becomes a mandatory product via lobbying efforts, the NASBE launched an Epinephrine Policy Initiative on December 10, 2012 featuring none other than, you guessed it, Mylan.

—NASBE’s press release stated:
”Arlington, VA — With the rise in reported food allergies among students in the last 15 years, it is crucial that policymakers understand how to best prepare school personnel to deal with related health emergencies. To help with those efforts, the National Association of State Boards of Education (NASBE) is launching a new initiative, in collaboration with Mylan Specialty, designed to help state boards of education as they develop student health policies regarding anaphylaxis and epinephrine auto injector access and use.”


www.nasbe.org/partners/nasbe-launches-epinephrine-policy-initiative/

—Here is a map of the USA via the Food Allergy Research and Education featuring the School Access to Epinephrine aka EpiPen and includes every state's legislation regarding stock and prescription carrying of epinephrine aka EpiPen in these cases.

www.foodallergy.org/advocacy/epinephrine/map#menu



•Joe Manchin

—Heather Bresch’s father.
—Democratic Governor of West Virginia 2005-2010
—US Democratic Senator of West Virginia since 2010.
—Enough said about him.



•Now, let me point your attention to a Lobbying Disclosure filed by Mylan during Q1 in 2012 after Heather Bresch became CEO of Mylan. In it a very important name is in it: LARA RAMSBURG

disclosures.house.gov/ld/pdfform.aspx?id=300474027


•Lara Ramsburg

—Ramsburg was the policy director for the West Virginia Governor in 2009.
—Joe Manchin, Bresch’s father, was Governor of West Virginia during 2009.
—Ramsburg was also the campaign spokeswoman for Manchin during his campaign for US Senate in 2010.
—Ramsburg was the VP of Government Relations for Mylan during 2012 when Bresch became CEO..
—Lobbying efforts were compensated $356,336.77 during Q1.
—What is the date signed by Lara Ramsburg on the disclosure: April 20, 2012.
—When did EpiPen4Schools started: August 2012
—When did Bresch’s mother, Gayle Manchin, use her husband's influence, along with Ramsburg’s lobbying efforts to launch the Epinephrine Policy Initiative: December 10, 2012


•When did the government get involved with EpiPen?

—After 2012.


•When were the most substantial price hikes of EpiPen made?

—After 2012


•Snippet from Heather Bresch’s testimony before the US House of Representatives Committee on Oversight and Government Reform

•”We announced the first ever generic version of the EpiPen product, which will be priced at $300. This unprecedented move is the fastest and most direct way to reduce the price for all patients.”

—Mylan’s epinephrine products are already generics. CEO Heather Bresch says before Chairman Jason Chaffetz that the “generic” will be the exact same product, the exact same “generic”

m.youtube.com/watch?v=bDfc_gMC370



—And because I am running out of time and have the best for another date…


•mnkdfann, I saved the last for you

•mnkdfann,  you said:

And a little later in the same article (where it discusses facts versus the above unsubstantiated allegations from two politicians):

"Mylan's EpiPen4Schools program gives free injectors to about 65,000 schools nationwide, and the company issued a statement Tuesday denying the claims its contracts included non-compete agreements."



— Duckworth went off on Mylan's EpiPen4Schools program. To get the drug, schools have to promise not to buy it from anyone else.

"That, to me, is an unfair monopoly," she said.

Bresch said the schools don't have to buy them if they don't want to.

"That's right, they don't have to buy them, but your own mother is out there ... passing out your guides for Mylan," Duckworth said.

She added that some of the schools being lobbied by Bresch's mother, who was president of the National Association of State Boards of Education, had no clue about her connection to the CEO.

Bresch said this simply wasn't true.

Rep. Mick Mulvaney also talked about government intervention in the project. He said his colleagues mostly asked questions about an industry it doesn't understand.

"I'll tell you what we do know, though, is that you've been in our hallways to ask us to make people buy your stuff," he said, saying that 11 states have laws requiring EpiPens be available in schools. "You've lobbied us to make the taxpayer buy your stuff. ... I was here when we did it."

He continued: "You came and you asked the government to get in your business, so here we are today. And I was as uncomfortable with some of these questions as you were ... but I have to defend both my Republican and Democrat colleagues for these questions because you've asked for it, so I guess this is my message.

"If you want to come to Washington, if you want to come to the state capitol and lobby us to make us buy your stuff, this is what you get. You get a level of scrutiny and a level of treatment that would ordinarily curl my hair, but you asked for it!"

And with that, Chaffetz called a recess.

www.businessinsider.com/mylan-ceo-heather-bresch-house-oversight-committee-hearing-epipen-2016-9