Mylan to pay $465 million to settle claims of overcharging CMS on EpiPens

Mylan, the manufacturer of EpiPen, will pay $465 million to the federal government to “resolve questions” about whether the autoinjector was misclassified as a generic drug, therefore reducing the quarterly rebates Mylan owed.

The settlement with the U.S. Department of Justice came days after CMS said it had been telling Mylan for years that EpiPen was wrongly classified as a generic, all while Medicare and Medicaid spending on the device increased by 463 percent. A letter from CMS Acting Administrator Andy Slavitt explained that Mylan, as a brand-name drug, should’ve been offering a rebate of at least 23 percent off the average price, instead of the 13 percent rebate allowed for generics. 

Mylan’s settlement doesn’t come with any admission of wrongdoing, and the company noted EpiPen had been classified as a generic long before it was acquired by Mylan in 2007.

"This agreement is another important step in Mylan's efforts to move forward and bring resolution to all EpiPen Auto-Injector related matters,” Mylan CEO Heather Bresch said in a statement.

Mylan has taken several steps to quell the controversy over the steep increase in EpiPen prices since it acquired the product, including offering a generic version at roughly $300 for a two-pack, which is still well above the price in other countries.

Sen. Ron Wyden, D-Oregon, the recipient of the CMS letter, appeared to be satisfied with this outcome.

"Today's news is a first step for taxpayers to get what they are owed from drug companies,” Wyden said in a statement. “I remain extremely concerned by the alarming trend of rising drug prices straining family budgets and taxpayers, and by how this was allowed to happen in the first place.”