Drug company to pay $3 billion to settle criminal charges
Nursing home antipsychotic legislation set aside
In what is the biggest healthcare fraud settlement in U.S. history, drugmaker 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.
GSK also pleaded guilty to charges that it promoted its asthma drug, Advair, for first-line therapy for mild asthma patients even though it was not approved for this usage. Additionally, GSK promoted Advair for chronic obstructive pulmonary disease with misleading claims.
“GSK also used a wide variety of gifts, payments and other forms of remuneration to induce physicians to prescribe GSK's drugs, including trips to Bermuda and Jamaica, spa treatments and hunting trips and sham consulting fees,” according to the federal complaint.
Click here to read all the court documents pertaining to the case.