Drug maker pays out millions over EpiPen charges

As Mylan continues to face criticism over price hikes on its EpiPen epinephrine injection, the company agreed to a $465 million settlement with the U.S. Department of Justice and other agencies for overcharging on the EpiPen.

Despite offering a generic version of its EpiPen in late August, Mylan has been unable to curb the backlash over the cost of the drug. After protests over EpiPen’s price spiking to more $600 per 2-pack this year, Mylan first said it would offer discounts on its EpiPen Auto-Injector treatment.

Related: Cheaper generic EpiPen doesn't quiet critics

After continued outrage over the price spike, the drug maker said recently that it would begin marketing the first generic version of EpiPen for around $300 per 2-pack, a discount of more than 50% to the Mylan list price, or wholesale acquisition cost (WAC) of the branded drug, according to a Mylan press release.

In the new settlement, Mylan aims to resolve questions about whether its EpiPen Auto-Injector was improperly classified as a generic drug with the Centers for Medicaid and Medicare Services (CMS), thereby causing the government to pay more for the drug than it should have.

Officials said spending on the EpiPen totaled nearly $1.3 billion from 2011 to 2015, according to The New York Times.

However, “The terms of the settlement do not provide for any finding of wrongdoing on the part of Mylan Inc. or any of its affiliated entities or personnel,” Mylan said in a statement.

EpiPen Auto-Injector has been classified with CMS as a non-innovator drug since before Mylan acquired the product in 2007, “based on longstanding written guidance from the federal government,” Mylan said.

Related: EpiPen discounts offered after pricing flap

"This agreement is another important step in Mylan's efforts to move forward and bring resolution to all EpiPen Auto-Injector related matters,” said Mylan CEO Heather Bresch in the statement.”The agreement is in addition to the significant steps Mylan has taken in relation to EpiPen Auto-Injector over the past several weeks, including the unprecedented, pending launch of a generic version of EpiPen Auto-Injector and expansion of our patient access programs for this product.”

The settlement terms provide for resolution of all potential rebate liability claims by federal and state governments as to whether the product should have been classified as an innovator drug for CMS purposes and subject to a higher rebate formula.

In connection with the settlement, Mylan expects to enter into a corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services. Mylan will continue to work with the government to finalize the settlement.

Read more: Americans want drug pricing reform