Medicaid programs nationwide will receive approximately $21,049,621.00 of the total settlement. Medicaid is 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 medically accepted indications. The unapproved uses of Keppra® were not eligible for reimbursement by state Medicaid programs.
The UCB settlement involved both criminal and civil components. Under the agreement, UCB pled guilty in federal court to one misdemeanor count of “misbranding” 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
Georgia Assistant Attorney General Scott A Smeal, who was on the State settlement team, stated, “UCB’s marketing of its drug Keppra for uses not approved by the FDA not only resulted in substantial financial loss to the Georgia Medicaid program, but also raised issues of patient safety. The Georgia Attorney General's office will continue to cooperate with federal agencies to investigate and prosecute such practices by pharmaceutical companies.”
The investigation was initiated by lawsuits filed in the United States District Court for the
A team representing the National Association of Medicaid Fraud Control Units participated in the investigation and conducted settlement negotiations with UCB on behalf of the states. Team members included representatives from