FDAnews Device Daily Bulletin

Mylan Reaches $465M Settlement of EpiPen Misclassification Charges

Oct. 20, 2016

Mylan will pay $465 million to settle claims that the company misclassified its epinephrine auto-injector EpiPen for the Medicaid Drug Rebate program, allowing it to pay lower reimbursement rate to states for almost a decade.

The company reached the agreement — which nearly totals the amount Medicaid and Medicare spent on the allergy treatment in 2015 — with the Department of Justice and other government agencies, Mylan said.

The agreement includes no admission of wrongdoing and clears Mylan of “all potential rebate liability claims by federal and state governments” regarding the emergency allergy treatment’s classification as a non-innovator drug or generic. — José Vasquez

View today's stories