UCB has agreed to pay $34.4 million to settle a dispute with the US Department of Justice regarding illegal promotion of its epilepsy drug Keppra.
The Belgian drugmaker's US subsidiary has pleaded guilty to a single misdemeanour violation and entered into a separate civil settlement agreement to resolve allegations relating to misbranding of Keppra (levetiracetam), UCB's lead product which is now off-patent. The government alleged that the company promoted the sale of the drug for off-label use in the treatment of migraine.
UCB noted that the events occurred more than six years ago, and it has cooperated fully with the US authorities since learning of the investigation in 2008. It has also signed a five-year corporate integrity agreement with the US Department of Health and Human Services.
Greg Duncan, UCB's president for North American operations said "we have worked diligently over the years to enhance our compliance programme and we continue to evolve our compliance efforts to meet the changing demands of the regulatory environment in which we operate. We are pleased to have resolved this matter."
Kathleen Martin-Weis, acting director of the US Food and Drug Administration’s Office of Criminal Investigations, said the guilty plea and settlement "is evidence of the government’s continued commitment to hold pharmaceutical companies accountable when they undermine the drug approval process". She added that “we will continue to join forces with the DoJ and our law enforcement counterparts to seek this kind of criminal resolution when pharmaceutical companies put profits ahead of the public health and safety".