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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