WISCONSINREPORT.COM (09/10/2010) - A company that has allegedly marketed an epileptic drug called Topamax improperly is in trouble with the United States Department of Health and Human Services, and the Food and Drug Administration. The firm has agreed to pay back some of the money gained through Medicaid programs because the medication was prescribed for ailments not FDA approved.
Wisconsin has joined with other states in reaching an agreement with Ortho - McNeil - Janssen Pharmaceuticals, Inc. to settle allegations that the company engaged in off-label marketing of its anticonvulsant drug, Topamax. The agreement calls for payment of $526,902.95 to Wisconsin as part of a federal and state share of $1,157,199.75 attributable to Wisconsin Medicaid, according to Wisconsin Attorney General J.B. Van Hollen.
Topamax is a drug that is approved by the Food and Drug Administration (FDA) to treat epileptic symptoms and to aid in the prevention of migraine symptoms.
Ortho-McNeil-Janssen Pharmaceuticals is settling allegations that it engaged in a scheme to improperly market Topamax for unapproved uses.
Despite Topamax’s limited indication, it is alleged that Ortho-McNeil-Janssen marketed the drug to physicians for a variety of psychiatric conditions (including, but not limited to, bipolar disorder and drug and alcohol dependency), and that as a result government healthcare programs such as Medicaid paid for more Topamax prescriptions than they should have.
Ortho-McNeil-Janssen will pay the state Medicaid Programs a total of $50,688,483.52, which will be allocated to the states and the federal government based on their joint funding of Medicaid.
The state settlement is part of the recent $75,370,000 settlement between the company and the United States that was announced by the United States Attorney’s Office for the District of Massachusetts on April 29, 2010. The remainder of the settlement, $24,106,000, is allotted for federal programs such as Medicare, TRICARE, and the Department of Veterans Affairs.
As part of the settlement, Ortho-McNeil-Janssen Pharmaceuticals has entered into a Corporate Integrity Agreement with the United States Department of Health and Human Services, Office of the Inspector General, which will closely monitor the company’s future marketing and sales practices.
“Recipients of medical assistance are expected to follow program rules – and so are providers,” noted Wisconsin Attorney General Van Hollen. “When they don’t, we’ll make every effort to hold them accountable and protect taxpayer dollars.”
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