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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: 3, Informative) by Zinho on Monday September 12 2016, @01:54PM

    by Zinho (759) on Monday September 12 2016, @01:54PM (#400701)

    He is also changing the dosing and the way that it is determined. I highly suspect that this sort of change requires significantly more testing than a simple change to the injector would require.

    I disagree; AllergyStop appears to be simply providing greater granularity in the dose than what's available through the EpiPen. The inventor isn't innovating on recommended dosage, he's simply providing the accurate dosage for the individual patient; doing so involves a doctor's examination to pick the correct amount (people lie about their weight) and length of needle to penetrate all the way to the muscle (people lie about their weight). As long as he's still following the FDA recommended dosage of 0.01mg serum/kg body weight I don't think that constitutes an innovation on dosage that the FDA would insist on testing.

    It appears from the video that he may also be offering standard size doses (i.e. same as EpiPen), for which he'd accept an EpiPen prescription. So if you want the same sloppy dosage you're already used to then it's available as well, likely at lower cost to the manufacturer.

    --
    "Space Exploration is not endless circles in low earth orbit." -Buzz Aldrin
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  • (Score: 2) by Fnord666 on Monday September 12 2016, @04:46PM

    by Fnord666 (652) on Monday September 12 2016, @04:46PM (#400801) Homepage

    I disagree; AllergyStop appears to be simply providing greater granularity in the dose than what's available through the EpiPen. The inventor isn't innovating on recommended dosage, he's simply providing the accurate dosage for the individual patient; doing so involves a doctor's examination to pick the correct amount (people lie about their weight) and length of needle to penetrate all the way to the muscle (people lie about their weight). As long as he's still following the FDA recommended dosage of 0.01mg serum/kg body weight I don't think that constitutes an innovation on dosage that the FDA would insist on testing.

    It seemed to me that introducing BMI into the dosing equation would deviate from the prescribed dosing. I'm not saying that it's a bad thing, just that it is different. Only the FDA can say whether it's different enough I guess. I'm not in the medical research field though, so take this as nothing more than an opinion.

    It appears from the video that he may also be offering standard size doses (i.e. same as EpiPen), for which he'd accept an EpiPen prescription. So if you want the same sloppy dosage you're already used to then it's available as well, likely at lower cost to the manufacturer.

    That makes sense since it would allow schools, etc. to immediately switch if the substitution is acceptable.