Lawmakers Say EpiPen was Misclassified, Medicaid OverCharged

Sept. 6, 2016

Amid the contraversy over Mylan's major price increases, the drugmaker is now being accused of overcharging Medicaid for the EpiPen.

In a letter to the secretary of the Department of Health and Human Services, two congressional committee members formally inquired about a possible misclassification of the EpiPen under the Medicaid program.

The letter said that while EpiPen was considered a branded drug in the new drug application to the FDA, it has been classified as a generic drug (also known as non-innovator multiple source drug) in the Medicaid program since at least 1997. This would mean Mylan has been underpaying rebates owed to Medicaid for EpiPen for almost a decade.

In a statement to Business Insider, Mylan responded, "The rule establishes a new process for pharmaceutical companies to follow if they have products, like EpiPen, approved under a what the FDA calls a 'new drug application' that they believe should continue to be treated as a non-innovator drug. The new process requires the submission of an application for non-innovator status to be submitted to CMS on or before April 1, 2017. Pursuant to the new rule, Mylan intends to file an application for non-innovator status regarding EpiPen on or before April 1, 2017."

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