U.S. Senators Richard Blumenthal, Charles Grassley, and Amy Klobuchar asked the Justice Department to investigate whether Mylan may have misclassified its EpiPen in order to pay lower rebates to the states.
In a letter released on Wednesday, the lawmakers noted that Mylan classified the EpiPen with the Medicaid Drug Rebate Program as a non-innovator multiple source drug, which pays a rebate of 13 percent to states, rather than innovator, which pays a rebate of a minimum of 23.1 percent.
“The facts … suggest that Mylan may have knowingly misclassified EpiPens, potentially in violation of the False Claims Act and other statutes,” the lawmakers said in a letter to Attorney General Loretta Lynch.
Mylan said in an email statement that its EpiPen was classified as a non-innovator drug since before Mylan purchased it in 2007. “Mylan’s classification of EpiPen Auto-Injector as a non-innovator drug is consistent with longstanding written guidance from the federal government,” the company said.
Mylan added in the statement that a new rule could change this status.
Mylan has been widely criticized for sharply raising the price of EpiPens, which are carried by people with life-threatening allergies. Mylan, which acquired the product in 2007, has raised the list price for a pair of EpiPens to $600 from about $100 in 2008.