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posted by martyb on Monday September 12 2016, @10:02AM   Printer-friendly
from the better-mousetrap-trapped-in-limbo dept.

AlterNet reports

The [EpiPen], which millions of Americans depend on, was invented in the 1970s by engineer Sheldon Kaplan[PDF], who died seven years ago in modest surroundings amid obscurity. But Kaplan's patent made its way into [the] Netherlands-based drug maker Mylan, which, since 2007, has jacked up the price of the spring-loaded injector from $57 a shot to $300.

[...] The high price [...] caught the attention of Dr. Douglas McMahon. The 38-year-old allergy specialist in St. Paul, Minnesota, has been thinking about how to improve on the EpiPen and to do so in a way that's affordable.

[...] McMahon saw that the EpiPen device was not only overpriced for what it does but also was too big to be easily carried in a pocket. For the past couple of years, he has been tinkering with injection-device components in his lab. And the result of his work is AllergyStop [1], an injection prototype that's small enough to fit on a key chain. McMahon claimed his device is as effective as the EpiPen and can be marketed and sold for about $50.

But, even though McMahon's device has been production-ready for the past two months, the steps he must take to get the device approved will cost him about $2 million and it will potentially take him years to go through all the hurdles required by the U.S. Food and Drug Administration for possible approval of his invention.

[1] All content is behind scripts. archive.li will run those for you.

Previously:
EpiPen's Price Increased 400% since 2008


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  • (Score: 1) by noneof_theabove on Monday September 12 2016, @11:39AM

    by noneof_theabove (6189) on Monday September 12 2016, @11:39AM (#400633)

    and Patent Office is highly needed....NOW!
    If the FDA took 1000 pens and made sure they did not fail injecting a liquid with a viscosity of EpiPen liquid, yes-it is harder to push thick stuff out a small needle and conversely a large needle and thin liquid may go faster than can be utilized causing leaking and blowout.

    So, if 999 devices pass that is a 0.1% failure, which the one should be sent back for "failure analysis" and correction.

    Now explain again why years and millions are need since the drug is not being tested....only the mechanical device.

    BTW...you can declare something GRAS [General Recoginized As Safe] and boom! Instant FDA approval.

    Welcome to the United Corporations and Churches of America - the best government any currency can buy.

  • (Score: 2) by dyingtolive on Monday September 12 2016, @01:22PM

    by dyingtolive (952) on Monday September 12 2016, @01:22PM (#400678)

    I don't disagree with your general sentiment, but: https://soylentnews.org/comments.pl?sid=15471&cid=400658#commentwrap [soylentnews.org]

    --
    Don't blame me, I voted for moose wang!