Mylan has agreed to a $465 million settlement with the US Department of Justice and other government agencies to resolve questions about whether EpiPen Auto-Injector was properly classified for the Medicaid Drug Rebate Program with the Centers for Medicaid and Medicare Services. The terms of the settlement do not provide for any finding of wrongdoing on the part of Mylan, the company said in a statement.

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 the Centers for Medicaid and Medicare Services’ 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.

Heather Bresch, Mylan chief executive officer, said in a statement: “This agreement is another important step in Mylan’s efforts to move forward and bring resolution to all EpiPen Auto-Injector related matters. 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.”

In August 2016, Mylan came under US government scrutiny regarding pricing of EpiPen Auto-Injector and has been dealing with demands for lower pricing.

Source: Mylan