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Pharmaceutical Company Pays Georgia Over $894,000 as Part of a Global Settlement to Resolve Criminal and Civil Healthcare Fraud Allegations

PRESS ADVISORY

Pharmaceutical Company Pays Georgia Over $894,000 as Part of a Global Settlement to Resolve Criminal and Civil Healthcare Fraud Allegations

June 10, 2011

Georgia 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. UCB is headquartered in Smyrna, Ga, and is a subsidiary of UCB SA, a Belgian pharmaceutical manufacturer.

Medicaid programs nationwide will receive approximately $21,049,621.00 of the total settlement.  Medicaid is funded jointly by the federal and state governments. Georgia will receive $894,512.00 in state and federal funds. The State portion is $371,171.00.

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 United States and participating state Medicaid programs $25,764,530, plus interest. 

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 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.