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Mylan to Pay $465 Million in False Claims Act Settlement

Pharma giant Mylan will pay $465 million to resolve False Claims Act (FCA) allegations that Mylan misclassified EpiPen as a generic drug to avoid paying Medicaid rebates owed to it under the Medicaid Drug Rebate Program, according to the United States Attorney’s Office of the District of Massachusetts.

After Mylan increased the price of EpiPen by 400% between 2010 and 2016, Sanofi, a competing pharmaceutical company, filed a qui tam lawsuit under the FCA. At the time, Sanofi was developing a competing epinephrine injection that it classified as a brand-name drug when calculating the Medicaid Drug Rebate Program. The Sanofi suit alleges that Mylan had misclassified the brand-name drug EpiPen as generic and didn’t calculate the rebates as if they were a single-source manufacturer. There was no FDA equivalent to EpiPen after Sanofi discontinued development of the drug. Sanofi will receive $38.7 million dollars as its share of the federal government’s recovery.

Mylan will enter into a Corporate Integrity Agreement with the Department of Health and Human Services under the agreement with the Department of Justice. It will require oversight of Mylan’s Medicaid Rebate Program.

Robert B. Vogel, MD, JD
Retinal Ophthalmologist at Piedmont Eye Center, Lynchburg VA;
Attorney, Overbey Hawkins & Wright, PLLS, Lynchburg, VA;
Adjunct Professor, Humanities and Bioethics, Liberty University School of Medicine, Lynchburg, VA.