FDA Finally Approves a Cheaper, Generic Version of the EpiPen

Illustration for article titled FDA Finally Approves a Cheaper, Generic Version of the EpiPen
Photo: Drew Angerer (Getty Images)

A life-saving but increasingly expensive treatment for severe allergic attacks is poised to become cheaper.

On Thursday, the Food and Drug Administration announced its approval of a generic version of the EpiPen and EpiPen Jr sold by pharmaceutical company Mylan. The approval comes in the wake of several scandals involving Mylan’s version, including an ongoing shortage of the drug.

The EpiPen is an auto-injectable device that shoots the hormone epinephrine into your system, rapidly halting the symptoms of a life-threatening allergic reaction. The hormone itself, perhaps better known as adrenaline, has long been generic and cheap to obtain. But the technology inside the EpiPen, developed in 1977, that allows it to be easily used by anyone with proper training is another story.

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Though there are other epinephrine autoinjectors available, Mylan has fiercely defended its stranglehold on the market, allowing it to keep raising prices. In 2007, when Mylan first bought its marketing rights, an EpiPen was $57, but by 2016, it had risen to around $600. Along the way, Mylan has reportedly bullied companies trying to develop cheaper versions of their product, including Teva Pharmaceuticals—the company behind the generic version approved by the FDA today. Teva had earlier failed to win approval for their version in 2016 and has sought to create a generic version since at least 2009.

“This approval means patients living with severe allergies who require constant access to life-saving epinephrine should have a lower-cost option, as well as another approved product to help protect against potential drug shortages,” said FDA Commissioner Scott Gottlieb in a statement.

In May, the FDA officially placed the EpiPen on its shortages list, following numerous manufacturing delays at the sole St. Louis factory where the product is produced. (Mylan markets Epipen, but it has a manufacturing partnership with the pharmaceutical company Pfizer.) The company has also had to deal with a growing number of reports concerning defective EpiPens believed to have injured and even killed users, according to internal FDA documents obtained by Bloomberg News.

Though the company has often brushed aside the swell of criticism over its high prices (sometimes by flat out lying about their profits), it’s also tried to worm itself back into the public’s good graces. In 2016, Mylan won approval to produce and sell their own generic version of the EpiPen. This version still sold for about $300, with the only difference being the lack of a brand name label. Last year, it also entered a $465 million settlement with the federal government over claims that it had ripped off Medicaid and Medicare (the company was allowed not to admit any wrongdoing). Ironically, it was accused of doing so by allegedly misrepresenting their product as a generic drug, apparently allowing them to overcharge for it.

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If there’s one bright side to all this, it’s that Mylan’s tricks have seemingly started to fall flat: Its revenue from the EpiPen has steadily fallen in recent years.

It’s unclear at this point how much Teva’s generic version will cost, though a generic version of a similar epinephrine autoinjector now costs around $100. Teva did not immediately respond to a request for comment from Gizmodo.

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[FDA]

Science writer at Gizmodo and pug aficionado elsewhere

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DISCUSSION

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In May, the FDA officially placed the EpiPen on its shortages list, following numerous manufacturing delays at the sole St. Louis factory where the product is produced. 

We really need to find a way to make sure there’s at least 2 manufacturing sources for essential drugs. Following Hurricaine Maria, the factories that produce a significant chunk of US pharmaceuticals were out of production. They were rushed back into production (not without controversy, though they’re both important to the US mainland and to PR’s economy), but if the factories themselves had endured more damage, its possible there wouldn’t have been enough medication to go around.

Plus, if you’ve only got one manufacturing facility, even small-scale issues can knock out production for an extended period of time: Local flooding, a tornado, fire, terrorism, etc. could impact drug production enough to cause a real shortage and shorten lives, impact quality of life, and generally have lots of negative consequences.

You can’t “cold turkey” lots of drugs, from blood pressure medications to antidepressants, and there’s real consequences for going without for many others (say, birth control to pain meds).

Maybe you need legislation for this, but it could be as simple as Medicare/Medicaid (or the VA) requiring that all drugs they purchase have at least 2 active manufacturing facilities.  Potentially, larger insurers (BCBS in a large state?) might have enough muscle to get this to happen.