In what is the biggest healthcare fraud settlement in U.S. history, drug maker GlaxoSmithKline will pay $3 billion and plead guilty to illegally promoting prescription drugs. Among other criminal charges brought by the Department of Health and Human Services, GSK pleaded guilty for failing to include safety data about the diabetes drug Avandia in reports to the Food and Drug Administration. According to the Department of Justice, GSK did not disclose post-marketing studies related to Avandia’s cardiovascular safety. Since 2007, Avandia has carried black box warnings about the potential increased risk of congestive heart failure, and myocardial infarction, according to court documents. It was pulled from retail pharmacy shelves last year.
