Mylan will pay the Department of Justice $465 million in a settlement over its pricing and Complete Series Archivesclassification of the EpiPen through Medicaid, the pharmaceutical company announced Friday.
Mylan, which came under fire this summer for systematically hiking the price of the life-saving device, at the same time allegedly improperly classified the EpiPen as a generic drug. That led Medicaid and Medicare to both overpay for the product.
The DOJ's question centered on the EpiPen's classification through Medicaid and Medicare. The EpiPen had been classified as a non-innovator drug, affecting how the federal programs calculated rebates.
The EpiPen is not a generic, and Mylan has been criticized for failing to develop a less expensive generic version. The rules regarding a generic version of an EpiPen are different since it is the device, not the active drug, that is subject to patents.
The $465 million pre-tax settlement will cover liability claims over rebates from federal and state governments.
While separate from the outrage surrounding EpiPen pricing for consumers, the DOJ's settlement with Mylan is another hurdle for the company as it tries to recover from its public shaming. The pharmaceutical company lost celebrity endorsements and prompted inquiries from lawmakers over its hike to the price of EpiPens to as much as $600 for a two-pack, up from $50 per pen in 2007.
Mylan denied in a statement Friday that the settlement implied any wrongdoing.
"This agreement is another important step in Mylan's efforts to move forward and bring resolution to all EpiPen Auto-Injector related matters," CEO Heather Bresch said in a 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. Entering into this settlement is the right course of action at this time for the company, its stakeholders and the Medicaid program."
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