Mylan finalizes $465M settlement on EpiPen
CANONSBURG – Mylan N.V. said Thursday it finalized a $465 million settlement with the U.S. Justice Department, resolving claims it overcharged the government for its EpiPen emergency allergy treatment, which became the center of a firestorm over price increases.
The settlement agreement came 10 months after Mylan, which is incorporated in the Netherlands but has its administrative headquarters in Southpointe, said it reached a deal for $465 million to resolve claims it misclassified the EpiPen as a generic rather than a branded product to avoid paying rebates owed to Medicaid.
Mylan did not admit wrongdoing in entering into the settlement.
“As we said when we announced the settlement last year, bringing closure to this matter is the right course of action for Mylan and our stakeholders to allow us to move forward,” Mylan CEO Heather Bresch said in a statement.
The EpiPen, which Mylan acquired in 2007, is a handheld device that treats life-threatening allergic reactions by automatically injecting a dose of epinephrine.
Criticism of the branded drug’s list price started snowballing last summer when parents doing back-to-school shopping encountered sticker shock at the pharmacy counter and began protesting to politicians and on social media.
In September, a Congressional panel grilled Bresch about the soaring cost, which she blamed in part on insurers, pharmacy benefits managers and other middlemen that stand between the drugmaker and the customer.
Federal investigators said Mylan raised EpiPen prices by about 400 percent between 2010 and 2016, when it came under fire after boosting the price of a pair of EpiPens to $600. In 2008, a year after Mylan acquired the product, the two-pack of pens were priced at $100.
Mylan has since offered its own generic version for about $300.
The Justice Department settlement centered on claims Mylan avoided higher rebates to state Medicaid programs by misclassifying the EpiPen as a generic product, even through the company marketed and priced it as a brand-name product.
The settlement allocates money to the Medicaid programs of all 50 states and establishes a framework for resolving all potential state Medicaid rebate liability claims within 60 days.