The pharmaceutical company UCB, Inc. has agreed to a $34 million settlement in Washington federal district court to resolve civil and criminal allegations over the misbranding of a prescription drug used in the treatment of seizures.
UCB, represented by Covington & Burling, agreed to plead guilty to a misdemeanor count for misbranding of the drug Keppra, court records show. The company is the U.S. subsidiary of the Belgian pharmaceutical UCB SA.
UCB also agreed to settle False Claims Act liability for nearly $26 million, making up the bulk of the global agreement. The payment resolves claims for reimbursement for Keppra by federal and state health care programs.
“UCB put its pursuit of profits ahead of its obligations to patients,” U.S. Attorney Ronald Machen Jr. said in a prepared statement. “Today’s guilty plea and UCB’s $34 million payout should remind drug companies that try to cleverly design off-label marketing schemes that we will not allow them to compromise patient safety.”
Prosecutors in Washington said UCB unlawfully marketed the drug for treatment for migraines even though the Food and Drug Administration never approved the drug for that purpose. The off-label market use for migraine treatment offered a higher sales potential than the market for epilepsy, prosecutors said.
The settlement includes a five-year corporate integrity agreement between UCB and the Department of Health and Human Services inspector general’s office. The agreement requires UCB to “maintain, monitor and enforce and detailed compliance program and code of conduct governing future promotional activities.”
The U.S. Attorney’s Office said the settlement resolves two whistleblower suits—one from 2007 and the other from 2008—in Washington and Oregon federal district courts. The whistleblowers will receive a total payment of more than $2.8 million for their role in the litigation, the government said.
A lawyer for UCB, Covington partner Ethan Posner, co-chair of the firm’s white-collar defense and pharmaceutical litigation groups, was not immediately reached for comment this afternoon about the settlement.
UCB’s lawyers said, contrary to the government’s assertions otherwise, that there was no evidence the promotion or use of Keppra for migraines caused actual harm to any patient.
“The UCB of 2011 is a different company than it was in the late 1990s and early 2000s,” the company’s lawyers said in court papers. Before the government investigation of the company, UCB directed its sales force to stop promoting Keppra for migraines, court records show.
Matthew Solomon, the chief of the U.S. Attorney Office’s fraud unit, prosecuted the UCB case with Assistant U.S. Attorney Sondra Mills.