PROVIDENCE, R.I. (Legal Newsline) - Rhode Island Attorney General Peter Kilmartin announced Friday that Rhode Island has joined nine other states and the federal government in reaching a $34.3 million agreement with pharmaceutical manufacturer, UCB Inc.
The company agreed to the settlement to resolve criminal and civil off-label marketing allegations against it for the drug Keppra.
The drug, approved by the Food and Drug Administration, is typically used to treat partial onset seizures in adults and children who are at least 4 years old. It also is used to treat tonic-clonic seizures in adults and children who are at least 6 years old, and myoclonic seizures in adults and children who are at least 12 years old.
However, a government investigation alleged that from Jan. 1, 2003 through March 31, 2005, the pharmaceutical company 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 FDA. Some of the uses, the investigation determined, 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," Kilmartin said in a statement. "It is illegal, unethical, and will not be tolerated."
The UCB settlement involved both criminal and civil components.
According to Kilmartin's office, 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 U.S. 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. Those states included: Colorado, Florida, Georgia, Michigan, Nebraska, New York, North Carolina, Rhode Island, Texas and Virginia.
From Legal Newsline: Reach Jessica Karmasek by e-mail at email@example.com.