Lawmakers have called on the Department of Justice to investigate whether Mylan violated the law by misclassifying its severe allergy treatment EpiPen as a generic in the Medicaid Drug Rebate Program.
In a letter, Senate Judiciary Committee Chairman Charles Grassley (R-Iowa) and two of the committee’s Democrats—Sens. Richard Blumenthal (Conn.) and Amy Klobuchar (Minn.)—asked Attorney General Loretta Lynch on Wednesday to look into whether the company knowingly misclassified the product so it could pay states a lower percentage of its EpiPen revenue.
The Medicaid Drug Rebate Program requires that makers of new drug products pay states a minimum rebate of 23.1 percent, but Mylan evaded these payments through the misclassification of its EpiPen and paid a 13 percent rebate, the senators said.
In recent weeks, Mylan has been criticized for raising the price of two EpiPen auto-injectors to about $600 since acquiring the product in 2007, when it cost roughly $100. The House Committee on Oversight and Government Reform grilled Mylan CEO Heather Bresch on the price hike last week, asking her to justify the increases.
The senators said the company’s actions violate the False Claims Act, but Mylan has defended the classification, citing a 1997 HHS opinion that granted Dey Laboratories, a former manufacturer of the EpiPen, permission to classify the product as a generic.
“The 1997 HHS opinion to Dey Laboratories may no longer be applicable given all of Mylan’s alterations and additions since then,” the senators wrote.
In a separate letter, Sen. Patty Murray (D-Wash.) has requested that Bresch release any communications, including emails, related to the price of the EpiPen dating back to April 2012.
The senator has asked for details on any agreements Mylan reached with Teva, which had sought approval for a generic epinephrine auto injector. — José Vasquez