UCB SA
Approved Evidence
UCB Subsidiary Pleaded Guilty and Company Paid More Than $34 Million Over Off-Label Keppra Promotion
In June 2011, UCB Inc., the U.S. subsidiary of Belgian pharmaceutical manufacturer UCB SA, pleaded guilty to a misdemeanor violation of the Food, Drug and Cosmetic Act relating to promotion of the epilepsy drug Keppra for uses not approved by the FDA. The resolution included an $8.6 million criminal fine and forfeiture and $25.7 million to resolve civil False Claims Act allegations. The government alleged that Keppra was promoted for various unapproved uses and that the conduct caused false claims to be submitted to government healthcare programs. UCB also entered a corporate integrity agreement. Source: U.S. Department of Justice https://www.justice.gov/archives/opa/pr/us-subsidiary-belgian-pharmaceutical-manufacturer-pleads-guilty-label-promotion-company-pay