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