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Re:EpiPen Price Rise Sparks Concern for Allergy Sufferers by Terr_ on Monday August 22, 2016 @09:28PM (#12340703)
So a "used" epi-pen's internal syringe might contain 4-5x more epinephrine than actually goes into a standard dose? I assume this means most of the expense of making it comes from the housing/mechanics. (And recouping whatever cost of QA/approvals.)
Re:EpiPen Price Rise Sparks Concern for Allergy Sufferers by chiph on Monday August 22, 2016 @10:14PM (#12340914)
I haven't worked with this class of medical device, but I expect the major cost of the unit is in the approvals and lawsuits.

So far as the pen itself - They've got some injection-molded plastic, where the mold costs are amortized across the production lifetime. A needle + syringe, which are probably subcontracted from Becton Dickinson. A spring. A printed label. And the medication itself (probably the #2 cost).

The assembly of the above all had to conform to the FDA's Good Manufacturing Practices rules. Every part & ingredient had to have trace-ability to their source. With documentation thereof.

When we got our device approved (in a looser classification than this) we had to get UL approval ($50k per test, per device, per test-run), and we had 3 people on staff whose sole purpose was navigating the FDA paperwork and their approval process. I never heard what that cost was, but it was substantial. And then we had an IP attorney, and corporate defense attorneys to respond to the inevitable lawsuits.

Re:EpiPen Price Rise Sparks Concern for Allergy Sufferers by smu3l on Monday August 22, 2016 @10:34PM (#12340984)
The drug itself is very cheap. With an Rx you can purchase an ampule with about 3 doses for < $10.[1] You can administer it with an insulin syringe, which I don't think requires an Rx. Of course administration is a lot more tedious and requires some training.

I worked at a summer camp where we would carry 1 or 2 pens plus a bunch of ampules if we were in a wilderness situation where we couldn't get to emergency care and needed more than one dose.

[1] http://www.buyemp.com/product/epinephrine-ampule

Re:EpiPen Price Rise Sparks Concern for Allergy Sufferers by yoohoocthulhu on Monday August 22, 2016 @11:55PM (#12341280)
The drug is cheap...because it's unpatentable (as a molecule anyway) and is old enough that any patents would be expired anyway.

The marketing of autoinjectors has some legitimate public health value, but it's also a clear business strategy to get new drug prices for an ancient drug