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FDA Slams EpiPen Maker for Doing Nothing While Hundreds Failed, People Died

If you have severe allergies that can cause anaphylactic reactions that literally close your airways, EpiPens are the link between life and death. In practice, someone experiencing an anaphylactic reaction will give themselves a quick injection from an EpiPen, and avert death. But in a scathing letter, the FDA reveals that the manufacturer’s own records show the pens not only failed in numerous cases, but that people died because of it, ArsTechnica reports. The manufacturer — a Pfizer-owned company that makes the pen for Mylan — also failed to investigate the problems or recall bad batches.

EpiPen sales brought in $1.2 billion in 2015. It costs Mylan about $1 to make the pens, but the list price for a two-pack is over $600 in the U.S. Although you’ve probably already heard these numbers when they were first brought to light in September 2016, I’m repeating them to show that we’re not talking about marginalizing profits by suggesting that Mylan — ultimately Pfizer — has no excuse for not putting extra effort into making sure these costly devices WORK.

Tragically, this is another example of how near-monopolies work for stockholders, but against the consumer. When the price-gouging news came to light, Mylan responded with intensive TV advertising and a conciliatory offer of financial assistance for people who can’t afford their pens. But how do you define “afford” — especially when the same pens sell for $400 less in Canada? Quite frankly, I’m angry that this is how it works for just about any drug, lifesaving or not, in the U.S.

In 2013, for instance, per capita spending on prescription drugs in the U.S. was $858 compared with an average of $400 in 19 other industrialized nations. A key part of the problem is the FDA grants certain new drugs with five- to 12-year windows of exclusivity, during which generic competitors may not come to the market. To lower your own drug costs, consider generic equivalents or purchasing your drugs from a reputable Canadian pharmacy whenever possible. Even more important, however, is to take control of your health — the first and best step to reducing your reliance on drugs now and in the future.
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