GlaxoSmithKline has paid the largest healthcare fraud settlement in recent history. It agreed to pay $3 billion to conclude the Justice Department’s investigation. The deal requires them to plead guilty to three counts and pay a $1 billion criminal penalty, plus another $2 billion to wrap up civil claims.
One reason the settlement is so large is that it’s so comprehensive. It includes the off-label marketing and kickback allegations as well as pricing and rebate claims. Glaxo’s arrangement also covers allegations that it downplayed the safety risks of its diabetes drug Avandia.
Glaxo plead guilty to misbranding charges, failing to report Avandia safety data to the FDA, for marketing Wellbutrin for various off-label uses, including weight loss, substance abuse and sexual dysfunction, encouraging the use of Paxil for children although it was not approved for anyone under 18, and for mismarketing five other drugs, including the asthma drug Advair and the seizure drug Lamictal as well as failing to report safety data to FDA.
Glaxo Agrees to Pay $3 Billion in Fraud Settlement
Drug giant Glaxo pleads guilty, fined $3B for drug marketing