Klobuchar, Blumenthal, Gillibrand Urge HHS to Clarify Circumstances of the EpiPen Misclassification, Call for Nationwide Investigation

Press Release

U.S. Senators Amy Klobuchar (D-MN), Richard Blumenthal (D-CT), and Kirsten Gillibrand (D-NY) today urged the Department of Health and Human Services (HHS) to clarify the circumstances of the EpiPen misclassification. Following Klobuchar and Blumenthal's August 30th inquiry to the Centers for Medicare and Medicaid Services (CMS), the agency revealed that Mylan had incorrectly classified EpiPen as a generic drug under the Medicaid Drug Rebate Program. This classification has a significant impact on the cost of EpiPens to states and the federal government through Medicaid. In a letter to HHS sent today, Klobuchar, Blumenthal, and Gillibrand called on the agency to clarify the circumstances of the EpiPen misclassification and to determine if other drugs have also been misclassified under the Medicaid Drug Rebate Program. Klobuchar, Blumenthal, and Gillibrand also pushed for a nationwide investigation to determine how much the misclassification of EpiPen has cost states and the federal government.

"Following an August 30 inquiry to the Centers for Medicare and Medicaid Services (CMS), the agency has informed us that Mylan incorrectly classified EpiPen as a non-innovator multiple source drug under the Medicaid Drug Rebate Program. This classification has a significant impact on the cost of EpiPens to states and the federal government through Medicaid," the lawmakers wrote. "This misclassification is particularly costly for states like Minnesota, Connecticut and New York that have experienced record high Medicaid enrollment thanks to increased access to health care. This is a burden not only to state and federal governments, but ultimately, to taxpayers. We write you today to clarify the circumstances of the EpiPen misclassification and to determine if other drugs have also been misclassified under the Medicaid Drug Rebate Program."

Last month, Klobuchar, the Ranking Member of the Antitrust Subcommittee of the Senate Judiciary Committee, called for the FTC to investigate Mylan Pharmaceuticals for possible antitrust violation. Klobuchar has also called for the Senate Judiciary Committee to hold a hearing to investigate the enormous increase in the price of EpiPens.

In August, Blumenthal demanded that Mylan lower the price of the EpiPens to an affordable, accessible level. He also joined Connecticut mothers, nurses and doctors to call on Mylan to end the unconscionable price gouging that is threatening to put the life-saving product out of reach for families, schools and first responders.

Klobuchar and Blumenthal joined U.S. Senators Chuck Grassley (R-IA), Patrick Leahy (D-VT), and Ron Johnson (R-WI) in asking the Food and Drug Administration (FDA) to answer questions about its approval process and other steps for alternatives to the EpiPen.

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