What explains such a rapid rise in price for a drug that has been around for several years? As a patent lawyer with particular experience in the pharmaceutical industry, I think it’s important to look at the role of patents and also FDA approvals in drug discovery and sales. Currently, a backlog of about 4,000 generic drugs is awaiting FDA approval. Both factors play a role in how both rare and common drugs, such as EpiPens, can shoot up in price so rapidly.


kleinbl00:

This article is stupidly wrong.

The EpiPen is crazy fucking expensive because it's a medical device, not a medical drug. Medical devices are regulated by the FDA a whole different way than drugs - there are no generics for devices and the device approval process is entirely different. In order to begin human trials you have to run long-term animal trials and any "substantial" change to the design of the device means that you have to redo all of your trials. So once you've climbed that hill, you can push everyone else down it.

Which is exactly what Mylan banked on:

    Mylan acquired the EpiPen line of epinephrine autoinjector devices from Merck KGaA as part of their 2007 deal.[20] The devices deliver about $1 worth of drug.[21] At that time annual sales were around $200M.[21] Heather Bresch, Mylan's CEO, saw an opportunity to increase sales in the US through marketing and advocacy, and the company launched a marketing campaign to increase awareness of the dangers of anaphylaxis for people with severe allergies that made "EpiPen" the equivalent of "Kleenex"; the company also successfully lobbied the FDA to broaden the label to include risk of anaphylaxis and in parallel, successfully lobbied Congress to generate legislation making EpiPens available in public places like defibrillators are, and hired the same people that Medtronic had worked with on defibrillator legislation to do so.[21] Mylan's efforts to gain market dominance were aided when Sanofi's competing product was recalled in November 2015 and further when Teva's generic competitor was rejected by the FDA in March 2016.[22] By the first half of 2015, Mylan had an 85% market share of such devices in the US[21] and in that year sales reached around $1.5B and accounted for 40% of Mylan's profit.

The truly exasperating part is that Mylan's epipen was developed for the fucking army for use in chemical warfare using public funds. Mylan saw a monopoly opportunity and crushed it. Because capitalism. Which is why your medical care should not be subject to the whims of capitalists.

The build cost of an EpiPen is probably under $5. The epinephrine it delivers is less than $1 wholesale. The rest of the cost is (A) profit (B) regulatory overhead to deal with the massive testing, reassurance, tracking and QAQC associated with an FDA-approved medical injection device. So a company could rise up and crush the shit out of (A), but they'd never get the funding to deal with (B) unless they promised not to.

Because capitalism.

Which is why your medical care should not be subject to the whim of capitalists.


posted by thenewgreen: 842 days ago