EpiPencil Hack Costs A Fraction Of EpiPen (Exclusive)

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Publish Date:
September 19, 2016
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The Parallax
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Summary

Pharmaceutical company Mylan made headlines at the end of August for increasing the price of an EpiPen two-pack beyond $600. In response, the same hacker who wants to help people homebrew their medication has figured out a way to make an alternative he calls the EpiPencil for about $35.

Michael Laufer, who holds a Ph.D. in mathematics from City University of New York and is not a medical doctor, has combined an off-the-shelf needle injector designed for diabetics with a syringe loaded with the correct dose of epinephrine, the life-saving hormone in EpiPens. Laufer demonstrated the EpiPencil for me last week. It took him fewer than three minutes to load the syringe, assemble the auto-injector, and inject himself with a harmless 0.3-milliliter dose of saline.

Mark A. Lemley, director of the Stanford University Program in Law, Science, and Technology, says the fact that Laufer is only providing information—not actually selling or distributing components—may keep him out of the FDA’s jurisdiction.

“While patients who build their own devices aren’t subject to the jurisdiction of the FDA, it has been very aggressive in going after even companies [that] just provide information, using any hook they can find,” Lemley says. “They shut down [genetic testing disclosures by] 23andMe by claiming that a plastic tube you spit into to send your DNA was a ‘medical device,’ for instance.”

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