Author Topic: Epipen shortage due to manufacturing problems  (Read 767 times)

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Online Applewood

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Epipen shortage due to manufacturing problems
« on: May 10, 2018, 12:27:10 PM »
Epipen shortage due to manufacturing problems

There's more trouble for users of Epipens and other auto-injectors for allergies - many are complaining of a shortage.

This could be life-threatening for some people. A patient advocacy group says it's received 400 complaints from patients in 45 states who say they can't get the devices, or they have to wait weeks to get one.

Mylan, which has the EpiPen brand, told the FDA a few months ago it had intermittent manufacturing problems.

...

According to the FDA, another brand, Auvi-Q, is not facing a shortage.

Excerpted.  More at:

http://6abc.com/health/epipen-shortage-due-to-manufacturing-problems/3451150/

***

Manufacturing problems, my [expletive].  Mylan wants to raise the price again.

Offline thackney

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Re: Epipen shortage due to manufacturing problems
« Reply #1 on: May 10, 2018, 12:33:04 PM »
The shortage applies to the Mylan-brand EpiPen, according to NBC News, as well as Mylan’s generic version and an autoinjector from another brand, Adrenaclick.

http://people.com/health/fda-nationwide-epipen-shortage/
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Offline thackney

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Re: Epipen shortage due to manufacturing problems
« Reply #2 on: May 10, 2018, 12:36:19 PM »
Food Allergy Research & Education (FARE) calls on the Food and Drug Administration (FDA), the Department of Health and Human Services (HHS)and the Trump Administration to take immediate action to address a growing national shortage of epinephrine auto-injectors. Epinephrine is the first-line treatment for anaphylaxis, a serious and potentially life-threatening allergic reaction associated with severe food allergies. Delayed use of epinephrine during an anaphylactic reaction can lead to death.

FARE wrote to FDA Commissioner Scott Gottlieb on May 1 to express concerns with the lack of availability of these devices. On May 3, the American Society of Health-System Pharmacists (ASHP) determined that there was a national shortage of epinephrine auto-injectors covering two of the three manufacturers currently selling FDA-approved products in the U.S., Mylan Pharmaceuticals (maker of EpiPen®, EpiPen Jr.®,and authorized generic versions of both) and Impax Therapeutics (maker of an authorized generic of Adrenaclick).

The only FDA-approved product currently sold in the U.S. that has not reported any shortage or supply issues is kaleo’s Auvi-Q®. All of the FDA-approved therapies contain the same medicine, epinephrine, but the delivery device – and instructions for using it in an emergency – are different for each product. Many patients rely on EpiPen and EpiPen Jr. (or their authorized generics).

The U.S. shortage follows an ongoing shortage of these devices already determined in Canada and the United Kingdom. They have been reporting issues with patient procurement of EpiPen and EpiPen Jr. for several months.

FARE calls on FDA to declare that the current lack of availability of epinephrine auto-injectors represents a national shortage, not just a “spot shortage” (as reported to Allergic Livingon April 30.) Among other criteria, FDA considers a product to be in shortage if “there is notice from the public or practitioners about the lack of product available in the market.”....

https://www.foodallergy.org/about/media-press-room/food-allergy-research-education-calls-on-fda-to-act-swiftly-on-reported
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Offline mountaineer

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Re: Epipen shortage due to manufacturing problems
« Reply #3 on: May 10, 2018, 12:41:19 PM »
Mylan's CEO is Heather Manchin Bresch, daughter of Sen. Joe Manchin (D-WV).
"Because men have lost the objective basis of certainty of knowledge of the thing in which they are working, more and more I fear we are going to find them manipulating science according to their own sociological or political desires rather than standing upon concrete objectivity." Francis A. Schaeffer

Online Applewood

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Re: Epipen shortage due to manufacturing problems
« Reply #4 on: May 10, 2018, 03:05:10 PM »
Mylan's CEO is Heather Manchin Bresch, daughter of Sen. Joe Manchin (D-WV).

Yep.  And a couple of years ago, she was roundly criticized when Mylan started gouging patients who needed Mylan's Epipens:

https://www.washingtonpost.com/news/the-fix/wp/2016/09/20/the-mylan-epipen-pricing-controversy-is-why-people-hate-politics/?noredirect=on&utm_term=.9f0b9b7e3d70


Offline mountaineer

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Re: Epipen shortage due to manufacturing problems
« Reply #5 on: May 10, 2018, 03:47:35 PM »
Yep.  And a couple of years ago, she was roundly criticized when Mylan started gouging patients who needed Mylan's Epipens
Not only that, but her mother got into the act:
Quote
Family matters: EpiPens had high-level help getting into schools
Jayne O'Donnell, USA TODAY
 Published 12:46 p.m. ET Sept. 20, 2016 | Updated 6:13 p.m. ET Sept. 21, 2016

After Gayle Manchin took over the National Association of State Boards of Education in 2012, she spearheaded an unprecedented effort that encouraged states to require schools to purchase medical devices that fight life-threatening allergic reactions.

The association’s move helped pave the way for Mylan Specialty, maker of EpiPens, to develop a near monopoly in school nurses’ offices. Eleven states drafted laws requiring epinephrine auto-injectors. Nearly every other state recommended schools stock them after what the White House called the "EpiPen Law" in 2013 gave funding preference to those that did.

The CEO of Mylan then, and now, was Heather Bresch. Gayle Manchin is Heather Bresch’s mother.  ... Rest of story
:nometalk:
"Because men have lost the objective basis of certainty of knowledge of the thing in which they are working, more and more I fear we are going to find them manipulating science according to their own sociological or political desires rather than standing upon concrete objectivity." Francis A. Schaeffer

Online Applewood

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Re: Epipen shortage due to manufacturing problems
« Reply #6 on: May 10, 2018, 04:02:18 PM »
@mountaineer

Yes.  Seems the Manchins are chiselers and lying thieves.  I would say that it's because they are Democrats, but lately, there are quite a few such snakes in the Republican Party as well.   

Whether this current "manufacturing problem" is legit or not - expect Mylan and the Manchins to make a tidy profit from it -- at the expense of patients who need this medication.

Offline Polly Ticks

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Re: Epipen shortage due to manufacturing problems
« Reply #7 on: May 10, 2018, 04:07:28 PM »
Ugh.  Guess I'll be reordering early for my kiddo, before the current ones are too close to their expiration dates.
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Offline Drago

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Re: Epipen shortage due to manufacturing problems
« Reply #8 on: May 11, 2018, 01:27:20 AM »
I am reading that only the Epipen brand is short right now (not helped by a giant recall last year).  There are at least 3 other epinephrine auto-injector manufacturers. Shortage info. from the FDA: https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Epinephrine+Injection%2C+Auto-Injector&st=c&tab=tabs-4&panels=0#

Other suppliers:
http://adrenaclick.com
https://www.auvi-q.com
http://epinephrineautoinject.com (Supply constricted? "TBD" by the FDA)

Last year's big recall of Epipens:  https://www.fda.gov/Safety/Recalls/ucm550173.htm

Offline rangerrebew

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Re: Epipen shortage due to manufacturing problems
« Reply #9 on: May 14, 2018, 07:50:38 AM »

Epipen Shortages Due To Production Problems: FDA

Production problems have made EpiPens hard to find in some areas of the United States, the Food and Drug Administration says.

The devices give a lifesaving shot of epinephrine to people suffering severe allergic reactions.

https://www.webmd.com/allergies/news/20180509/epipen-shortages-due-to-production-problems
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Offline Mod1

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Re: Epipen shortage due to manufacturing problems
« Reply #10 on: May 14, 2018, 08:06:17 AM »
Merged threads

Offline mountaineer

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Re: Epipen shortage due to manufacturing problems
« Reply #11 on: May 14, 2018, 12:06:37 PM »
Manchin Lines His Campaign Coffers As Mylan Workers Are Shown The Door
 April 26, 2018


   *  Last Friday, Mylan announced they were laying off about 15 percent of their workforce at their Morgantown, West Virginia plant.
   *  The layoffs are the latest in a string of questionable business practices by Senator Manchin's Mylan executive allies, overseen by Manchin's daughter and Mylan CEO Heather Bresch.
   *  Under Bresch's watch, the cost of the EpiPen, a life-saving device used by adults and kids, increased by close to 500 percent.
   *  Mylan was forced to pay $465 million after the Department of Health and Human Services found they overcharged taxpayers by at least $1.27 billion for Medicaid reimbursement of the EpiPen.
   *  Meanwhile, Bresch and other executives have seen their salaries grow during these scandals and there were calls for Mylan's board to be ousted over a $98 million pay package given to Chairman and former CEO Robert Coury in 2016.
   *  Amidst the layoffs and scandals, Mylan has continued to contribute to Manchin's war chest for his upcoming election.
   *  Mylan executives and employees contributed more than $50,000 to Manchin's campaign in the first quarter of 2018.
   *  Mylan-connected individuals and PACs are Manchin's second-largest group of donors, contributing at least $132,000 before this most recent filing.  ...

More at GOP.com
"Because men have lost the objective basis of certainty of knowledge of the thing in which they are working, more and more I fear we are going to find them manipulating science according to their own sociological or political desires rather than standing upon concrete objectivity." Francis A. Schaeffer

Online Applewood

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Re: Epipen shortage due to manufacturing problems
« Reply #12 on: May 14, 2018, 02:59:34 PM »
What a guy.  Hope he will be shown the door this year. 


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