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MADISON — Attorney General J. B. Van Hollen announced today that Wisconsin has joined other states and the federal government to reach an agreement in principle with pharmaceutical manufacturer, UCB, Inc., to settle allegations of causing false or fraudulent claims for the drug Keppra® to be submitted to the Medicaid program.
Wisconsin will receive $224,629.43 as part of $509,665.68 attributable to Wisconsin's program. Medicaid is a health care assistance program for the needy funded jointly by the federal and state governments. Keppra®, an anti-epileptic drug, was approved by the Food and Drug Administration for several indications related to epilepsy.
The government's investigation revealed that from January 1, 2003, through March 31, 2005, UCB promoted the sale and use of Keppra® for headaches, migraines, pain, bipolar, mood disorders, and anxiety, all of which were uses not approved by the Food and Drug Administration. Further, some of the uses were not for medically accepted indications. The unapproved uses of Keppra® were not eligible for reimbursement by state Medicaid programs.
“Providers, just like recipients, have to follow program rules. Those rules protect the integrity of the program. Only by enforcing them can we protect taxpayer dollars and make sure that those who need it most can get the help they need,” stated Van Hollen.
The UCB settlement involved both criminal and civil components. Under the agreement, UCB pled guilty in federal court to one misdemeanor count of “misbranding” in violation of the federal Food, Drug and Cosmetic Act. As part of the criminal plea, UCB agreed to pay a fine and costs totaling $8,631,152. In addition, to resolve civil allegations UCB agreed to pay the United States and participating state Medicaid programs $25,764,530, plus interest.
The investigation was initiated by lawsuits filed in the United States District Court for the District of Columbia and the District of Oregon under the qui tam provisions of the federal and similar state false claims statutes, including Wisconsin's False Claims Act.