The settlement would include both the US DOJ and the Attorneys General of many of the US, in resolution of two False Claims Act qui tam actions initiated by whistleblowers and alleging violations of the False Claims Act related to UCB’s provision of the anti-epileptic prescription pharmaceutical, Keppra, to various government programs, including Medicare, Medicaid, and the VA Hospitals and State Medicaid programs.
Under the agreement, UCB agreed to pay $8.6m under the Federal Food, Drug and Cosmetic Act.
UCB entered into a separate civil settlement agreement and will pay $25.8m plus modest interest to the US and State Medicaid programs to resolve allegations relating to the False Claims Act.
UCB also agreed to enter into a five-year corporate integrity agreement (CIA) with the Office of Inspector General of the US Department of Health and Human Services.
The commitments in the CIA are also consistent with UCB’s previously stated commitment to comply with the laws and regulations that govern the pharmaceutical industry as evidenced last year by the company’s voluntary public certification to adhere to PhRMA’s Code on Interactions with Healthcare Professionals.
UCB North American Operations president Greg Duncan said they are pleased to have resolved this matter and look forward to continue to work with the many organizations with whom they partner to advance their mission of transforming the lives of people living with severe diseases.
Keppra is indicated to treat partial onset seizures in adults and children who are at least 4 years old.
It is also 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.