Endo, U.S. Department of Health and Human Services (HHS) neurology, drug delivery news
Endo will pay $192.7 million to settle criminal and civil claims that the company marketed its Lidoderm lidocaine patch for non-approved uses between 1999 and 2007. Endo will pay $171.9 million to the federal government, the District of Columbia and the states involved in the case. Endo agreed to pay $20.8 million under a two-and-a-half year deferred prosecution agreement in which Endo must implement compliance measures, such as making results of certain clinical trials publicly available and requiring an annual review of compliance efforts of its Endo Pharmaceuticals Inc. subsidiary.
Endo also agreed to a five-year Corporate Integrity Agreement with HHS and the Office of Inspector General (OIG), which are requiring Endo to implement an internal risk assessment and mitigation program and internal and external reviews of promotional practices. ...