Earlier this week, in a letter to the Centers for Medicare & Medicaid Services (CMS), Klobuchar called on the agency to provide information on the effect of Mylan’s price increases on government prescription drug costs, asking specifically why EpiPen was classified as a generic drug under the Medicaid Drug Rebate Program
Following Klobuchar’s efforts, CMS found that Mylan had misclassified the EpiPen as a “Non-Innovator Multiple Source Drug,” or generic drug, resulting in millions of dollars in overpayment for the drug by states and the federal government through the Medicaid Drug Rebate Program
WASHINGTON, DC – U.S. Senator Amy Klobuchar made the following statement on the drug category misclassification of Mylan Pharmaceutical’s EpiPen. Earlier this week, in a letter to the Centers for Medicare & Medicaid Services (CMS), Klobuchar called on the agency to provide information on the effect of Mylan’s price increases on government prescription drug costs, asking specifically why EpiPen was classified as a generic drug under the Medicaid Drug Rebate Program. Following Klobuchar’s efforts, CMS found that Mylan had misclassified the EpiPen as a “Non-Innovator Multiple Source Drug,” or generic drug, resulting in overpayment for the drug by states and the federal government through the Medicaid Drug Rebate Program.
“I am deeply troubled by Mylan’s misclassification of the EpiPen as a generic drug. The Minnesota Department of Human Services has estimated that this misclassification will cost our state more than $4 million dollars in overpayment this year alone. That’s just one state, over the course of one year, for one drug,” Klobuchar wrote. “This egregious action warrants an immediate and thorough nationwide investigation by the Centers for Medicare and Medicaid Services into the overpayments by all states. I will not stand by as American taxpayers continue to foot the bill for unjustified high prices of the lifesaving medications they need.”
The letter to CMS was also signed by Senators Chuck Grassley (R-IA) and Richard Blumenthal (D-CT). This news follows Klobuchar’s calls last week for the Food and Drug Administration to answer questions about its approval process and other steps for alternatives to the EpiPen, for the Senate Judiciary Committee to hold a hearing to investigate the enormous increase in the price of EpiPens, and for the Federal Trade Commission to investigate Mylan Pharmaceuticals.
Klobuchar has championed efforts to address the high cost of prescription drugs, authoring multiple pieces of legislation that would protect American consumers. She has introduced the Medicare Prescription Drug Price Negotiation Act of 2015, that would empower Medicare to negotiate for the best possible price of prescription medication. Current law only allows for bargaining by pharmaceutical companies and bans Medicare from doing so. She has also introduced the Safe and Affordable Drugs from Canada Act with Senator John McCain (R-AZ) that would require the Food and Drug Administration to establish a personal importation program that would allow individuals to import a 90-day supply of prescription drugs from an approved Canadian pharmacy. The Preserve Access to Affordable Generics Act would expand consumers’ access to the cost-saving generic drugs they need and increase competition between drug manufacturers and choices for consumers by helping to put an end to “pay for delay” deals—the practice of brand-name drug manufacturers using anti-competitive pay-off agreements to keep more affordable generic equivalents off the market. She also joined with Senators Chuck Grassley (R-IA), Patrick Leahy (D-VT), and Mike Lee (R-UT) to introduce the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act to deter pharmaceutical companies from blocking cheaper generic alternatives from entering the marketplace.