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Senators Ask DOJ to Investigate EpiPen-Maker Mylan

Posted in Antitrust, FDA, Legislation and Public Policy, Life Sciences, Medical Devices, Medicare and Medicaid, Pharmaceuticals, Reimbursement Matters

Day Pitney’s Eric Fader was quoted in a September 28 article, “Senators Ask DOJ to Investigate EpiPen-Maker Mylan,” in Bloomberg BNA’s Pharmaceutical Law & Industry Report, Life Sciences Law & Industry Report, Medical Devices Law & Industry Report, and other publications. The article discusses the request by Senate Judiciary Committee members that the U.S. Department of Justice investigate whether Mylan violated the law when it allegedly misclassified the EpiPen for purposes of the Medicaid drug rebate program.

Mylan classified the EpiPen as a “non-innovator multiple source drug,” or generic drug, in 2007 based on a 1997 government opinion. “It appears to me that Mylan’s explanations have been disingenuous,” Eric said. “Referring back to something that was done in 1997 and acting as though nothing changed in the intervening years is, I think, a losing strategy.”

Additionally, Eric said Mylan’s recent decision to offer its own authorized generic version of the EpiPen, which baffled many industry observers, may have been an attempt “to bolster their argument that the drug is really a generic and the EpiPen is really just a nice, trademarked branding for a generic drug.”

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