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Pharmaceutical Company UCB Inc. Settles Health Care Fraud Allegations
June 10, 2011
AUGUSTA – Attorney General William J. Schneider announced today that Maine reached an agreement with pharmaceutical manufacturer UCB Inc. (UCB) to settle allegations of submitting false claims for its epilepsy drug Keppra to MaineCare, the Maine Medicaid program.
Medicaid programs nationwide will receive approximately $25.7 million of the $34 million settlement resolving criminal and civil liability arising out of UCB’s off-label promotion of its anti-epileptic drug. Maine will receive approximately $43,000 as a result of the settlement.
Keppra was approved by the Food and Drug Administration (FDA) as an anti-epileptic drug for the treatment of seizures in adults and children suffering from epilepsy. Once approved by the FDA, a manufacturer may not market or promote a drug for any use not specified in the FDA-approved product label. These uses are also known as unapproved or “off-label” uses.
The federal 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. These off-label uses were not medically accepted indications and not eligible for reimbursement by state Medicaid programs under the False Claims Act.
“UCB put profit ahead of patients,” said Attorney General Schneider. “This settlement shows our continuing efforts to pursue and recover Maine taxpayer dollars for health care fraud.”
The UCB settlement involved both criminal and civil components. Under the terms of the plea agreement before the U.S. Court for the District of Columbia, UCB pled guilty to one misdemeanor count of misbranding in violation of the Food, Drug and Cosmetic Act. The government alleged that UCB promoted the sale of Keppra for off-label use in the treatment of migraine by generating and disseminating posters representing that Keppra was safe and effective for treating migraine based on purportedly independent investigator-initiated studies. The posters did not disclose UCB’s sponsorship of these studies or that UCB’s own clinical trial had failed to demonstrate that Keppra was effective in treating migraine.
The civil settlement was reached by the U.S. Attorney’s Offices for the District of Columbia, the District of Oregon and the Commercial Litigation Branch of the U.S. Department of Justice Civil Division. Assistance was provided by the National Association of Medicaid Fraud Control Units with Maine represented by Assistant Attorney General Michael Miller, Director of the Healthcare Crimes Unit.
The Healthcare Crimes Unit is the Medicaid Fraud Control Unit for the State of Maine charged with investigating and prosecuting financial fraud and other crimes committed by MaineCare providers or their employees, and investigating and prosecuting abuse, neglect or exploitation of elderly and dependent persons that occurs in health care facilities or by health care providers.
To learn more about the Office of the Attorney General Healthcare Crimes Unit, go to:
CONTACT: Brenda L. Kielty (207) 626-8577