Department of Justice Reveals Proposed $34 million Civil and Criminal Settlement
The U.S. Department of Justice revealed today a proposed $34 million civil and criminal settlement with Brussels, Belgium-based pharmaceutical giant UCB for marketing of its drug Keppra in violation of FDA law.
The company pleaded guilty to one count of promoting the epilepsy treatment drug, Keppra, in the United States in 2004 for migraine treatment without the necessary approval from the Food and Drug Administration, the U.S. Department of Justice said.
The drug was only approved by the FDA to help treat those who have seizures from epilepsy.
"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," said U.S. Attorney Ronald Machen.
The case is the latest settlement by a major pharmaceutical company over touting drugs in the United States for uses that have not been approved by the FDA, known as off-label promotion.
UCB will pay about $8.6 million in criminal fines and forfeiture and another $25.8 million to settle parallel civil allegations involving false claims submitted to U.S. federal healthcare programs, according to the plea agreement.
The company was accused of promoting Keppra with posters that claimed it was safe and effective for migraines and cited studies that it also claimed were independent -- but in fact were sponsored by UCB, according to the Justice Department.
Murphy Anderson's Ann Lugbill and Mark Hanna were co-counsel with Rebecca Webber of Linnell, Choate & Webber, LLP for one of the whistleblowers. Murphy Anderson attorney Michelle Woolley also assisted in the matter.