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Mylan is recalling some EpiPens distributed between December 2015 and July 2016, saying a potentially defective part could make them fail to activate during a life-threatening allergic reaction.
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The Auvi-Q epinephrine injector was pulled from the market in 2015 because of quality concerns. Now, the drug's maker says the problems have been solved and Auvi-Q will be available again in 2017.
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In testimony prepared for a congressional hearing, Mylan CEO Heather Bresch says the company makes about $50 in profit on each EpiPen. Analysts say it's still a hefty margin.
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The company's lobbying of state legislatures is just one factor in EpiPen's dominance of the market. Manufacturers of competing devices have struggled to gain a foothold.
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Mylan's move comes amid pressure from consumers and Congress to lower the allergy drug's price. In less than 10 years, the price has risen from about $100 to more than $600 for an injector two-pack.
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EpiPen, the new poster child for prescription drug price gouging, may find that offering discount coupons isn't enough to mollify its critics in Congress and online.
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Lawmakers are demanding answers as to why the price of EpiPens, which are used to stop life-threatening allergic reaction, keeps going up. The company said Thursday it will reimburse some of the cost.