US FDA warns against $30 DIY alternative to Mylan's EpiPen

By Dan Stanton contact

- Last updated on GMT

Image: iStock/Roel Smart
Image: iStock/Roel Smart

Related tags: Food and drug administration

The US FDA has warned people not to use a $30 DIY epinephrine delivery device developed after Mylan increased the price of the Epipen.

The latest pricing scandal to hit the pharmaceutical industry surrounds the life-saving allergy drug-device product EpiPen. The drugmaker has hiked the price up 17 times since 2007, a total of 548%, and a two-pack of EpiPens now cost US consumers over $600 (€540).

Amid accusations of patient extortion and corporate greed, Mylan CEO Heather Bresch defended her company’s decision yesterday​ during a questioning by members of the US House Oversight and Government Reform Committee, saying after all costs are incurred Mylan’s profit on the device sits at around $50 per pen.

EpiPencil

But a group of pharma hackers known as ‘The Four Thieves Vinegar Collective’ say they have made an epinephrine autoinjector costing just over $30 and in a blogpost are encouraging patients in need of this life-saving drug to construct the delivery device themselves.

The so-called ‘Epi-Pencil’ consists of three parts: an Owen Mumford non-fixed needle autoinjector, a 1cc/ml sterile syringe and a BD PrecisionGlide Single-Use Hypodermic Needle, all available from online suppliers.

Combined with a vial of prescription epinephrine – costing around $5 – Michael Laufer, chief spokesman for the collective, demonstrates how to construct and administer a dose within minutes.

“EpiPens save lives every day, but only for those who can afford them,”​ he said in his blogpost.

“We have developed the EpiPencil, an epinephrine autoinjector which can be built entirely using off-the-shelf parts, for just over $30 US.”

The Collective also boasts instructions for patients to make their own Daraprim (pyrimethamine), the toxoplasmosis drug which made headlines last year​ when former Turing Pharmaceuticals Martin Shkreli hiked the price up from $13.50 to $750 a tablet.

We contacted The Four Thieves Vinegar Collective and Laufer told us his EpiPencil is "a plausible alternative" to Mylan's multi-hundred dollar device. "In most ways it is equivalent."

FDA warning

However, the US Food and Drug Administration (FDA) did not agree, and told in-Pharmatechnologist such DIY medical devices put patients at risk.

It's essential to remember that epinephrine auto-injectors are life-saving products, and it is critical that they are made to a high standard of quality so patients can rely on them to work safely and effectively,”​ Agency spokesman Kristofer Baumgartner said.

“Using unapproved prescription drugs for personal use is a potentially dangerous practice.  Neither FDA nor the American public have any assurance that unapproved products are effective, safe or produced under Current Good Manufacturing Practices (CGMP).‎ Unapproved drugs may be contaminated, sub-potent, super-potent or counterfeit.”

Last month​, FDA commissioner Robert Califf received a letter from the US Committee on Energy and Commerce citing its concerns about the lack of generic competition in the epinephrine auto-injector space.

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