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.
All Bloomberg BNA treatises are available on standing order, which ensures you will always receive the most current edition of the book or supplement of the title you have ordered from Bloomberg BNA’s book division. As soon as a new supplement or edition is published (usually annually) for a title you’ve previously purchased and requested to be placed on standing order, we’ll ship it to you to review for 30 days without any obligation. During this period, you can either (a) honor the invoice and receive a 5% discount (in addition to any other discounts you may qualify for) off the then-current price of the update, plus shipping and handling or (b) return the book(s), in which case, your invoice will be cancelled upon receipt of the book(s). Call us for a prepaid UPS label for your return. It’s as simple and easy as that. Most importantly, standing orders mean you will never have to worry about the timeliness of the information you’re relying on. And, you may discontinue standing orders at any time by contacting us at 1.800.960.1220 or by sending an email to email@example.com.
Put me on standing order at a 5% discount off list price of all future updates, in addition to any other discounts I may quality for. (Returnable within 30 days.)
Notify me when updates are available (No standing order will be created).
This Bloomberg BNA report is available on standing order, which ensures you will all receive the latest edition. This report is updated annually and we will send you the latest edition once it has been published. By signing up for standing order you will never have to worry about the timeliness of the information you need. And, you may discontinue standing orders at any time by contacting us at 1.800.372.1033, option 5, or by sending us an email to firstname.lastname@example.org.
Put me on standing order
Notify me when new releases are available (no standing order will be created)