Mylan is continuing to get in trouble for classifying the EpiPen as a generic drug for purposes of the Medicaid drug rebate program.
Senate Judiciary Committee members Sept. 28 sent a letter to the Department of Justice asking for an investigation into whether Mylan violated the law when it classified the EpiPen as a non-innovator multiple source drug (NIMS), or generic drug, in 2007 for the Medicaid rebate program.
Under the Medicaid drug rebate program, companies are required to pay a higher rebate to states for brand-name drugs than for generics.
“Companies can reap huge profits, at the expense of the states and taxpayers, by misclassifying innovator drugs as NIMS drugs,” the letter said. The lawmakers said Mylan may have knowingly misclassified EpiPens, potentially in violation of the False Claims Act and other statutes. The False Claims Act is a U.S. law that penalizes companies or individuals who defraud the government. A violation of the False Claims Act could subject Mylan to steep penalties and damages.
Sens. Richard Blumenthal (D-Conn.), Charles Grassley (R-Iowa) and Amy Klobuchar (D-Minn.) signed the letter. Grassley is the chairman of the Senate Judiciary Committee.
The senators' request to the DOJ follows a Sept. 12 letter from members of the House Energy and Commerce Committee to the Health and Human Services Office of Inspector General, asking why the Centers for Medicare & Medicaid Services “persistently” classified Mylan’s EpiPen as a generic drug under the Medicaid rebate program. Sen. Ron Wyden (D-Ore.) and Rep. Frank Pallone Jr. (D-N.J.) also sent a letter Sept. 2 to the HHS asking about EpiPen's classification.
Stay on top of new developments in health law and regulation with a free trial to the Health Law Resource Center.
Learn more about Bloomberg Law and sign up for a free trial.
Notify me when updates are available (No standing order will be created).
Put me on standing order
Notify me when new releases are available (no standing order will be created)