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EpiPen maker Mylan to pay $465M in settlement with U.S. government

Mylan NV on Friday said it will pay $465 million US to settle the question of whether misclassification of its EpiPen emergency allergy treatment resulted in underpayment of rebates to the U.S. Medicaid healthcare program.
In this photo illustration, EpiPen, which dispenses epinephrine through an injection mechanism for people with severe allergies, is seen as the company that makes it Mylan Inc. has come under fire from consumers and lawmakers for the price that it is currently charging on August 16, 2016 in Hollywood, Florida. Reports indicate that the cost of a pair of EpiPens has risen 400 percent from when the Mylan acquired the original company in 2007. ( Joe Raedle/Getty)

Mylan NV on Friday said it will pay $465 million US to settle the question of whether misclassification of its EpiPen emergency allergy treatment resulted in underpayment of rebates to the U.S. Medicaid healthcare program.

The company has come under scrutiny for raising prices on the lifesaving EpiPen sixfold in less than a decade, making the devices unaffordable for a growing number of families.

Mylan, which will make the payment to the Department of Justice and other government agencies, said the settlement does not include any finding of wrongdoing.

​Figures released by Centers for Medicare and Medicaid Services on Wednesday showed that U.S. government health plans spent more than $1 billion on Mylan's EpiPen between 2011 and 2015.

U.S. lawmakers have contended that Mylan underpaid rebates to state Medicaid programs by misclassifying EpiPen as a generic instead of a branded drug. The Medicaid rebate for a generic is 13 percent compared with a minimum 23.1 percent for a branded drug.

Mylan said it will record a pre-tax charge of about $465 million in the quarter ended Sept. 30.

The company, citing changes to the EpiPen consumer discount program and upcoming launch of a generic version of the treatment, said it now expects full-year 2016 adjusted earnings per share of $4.70 to $4.90, down from a previous range of $4.85 to $5.15 per share.

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