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Pharmaceutical Company Pays More Than $34.3 Million to Resolve Criminal and Civil Off-Label Marketing Allegations

Attorney General Peter F. Kilmartin announced today that Rhode Island 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 Keppra® to be submitted to the Medicaid program.

Medicaid programs nationwide will receive approximately $21,049,621 of the total settlement. Medicaid is funded jointly by the federal and state governments. Rhode Island will receive $27,362.77.

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.

“Off label marketing of pharmaceutical drugs is extremely dangerous. Drug companies who engage in this practice are putting profits above patient safety,” said Attorney General Kilmartin. “It is illegal, unethical, and will not be tolerated.”

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 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 False Claims Act and similar state false claims statutes.

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 Colorado, Florida, Georgia, Michigan, Nebraska, New York, North Carolina, Texas and Virginia.

The Attorney General’s Medicaid Fraud Control and Patient Abuse Unit enforces the laws pertaining to fraud in the state Medicaid program and prosecutes cases of abuse, neglect or mistreatment of patients in all state healthcare facilities. The Unit prosecutes criminal activity, pursues civil remedies where appropriate and participates with federal and state authorities in a variety of inter-agency investigations and administrative proceedings.

Since January, 2011, the Attorney General has recovered approximately $1 million on behalf of Rhode Island’s Medicaid program.

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