In the largest health care fraud settlement in U.S. history, health care giant GlaxoSmithKline LLC agreed to pay $3 billion in civil and criminal penalties for introducing misbranded drugs and failing to report safety data, according to a Justice Department announcement Monday.
The United Kingdom-based pharmaceutical company will pay $1 billion in criminal fines and $2 billion in civil penalties, according to a department news release. GSK announced the settlement last year, stating on its website that the resolution was “in the best long-term interests of shareholders.”
“Today’s multi-billion dollar settlement is unprecedented in both size and scope. It underscores the Administration’s firm commitment to protecting the American people and holding accountable those who commit health care fraud,” James M. Cole, Deputy Attorney General, said in a news release.
The drugmaker admitted to illegally promoting Paxil to children as a depression medication, which is not an approved use for the drug by the Food and Drug Administration. It also illegally promoted the use of Wellbutrin for weight loss and treating substance addictions, among other off-label uses.
The company also failed to report safety data to the FDA about diabetes drug Avandia.
Federal prosecutors began an investigation of the company in Colorado in 2004, which was later taken over by the U.S. Attorney in Massachusetts.
This is not the first time the company has come under scrutiny. GSK paid $600 million to resolve False Claims Act allegations that it produced tainted medications in 2010. It also paid an additional $150 million in criminal fines.