British pharmaceutical giant GlaxoSmithKline has agreed to pay $3 billion to settle criminal and civil charges in the U.S. that it illegally promoted two popular antidepressant drugs for indications it was not approved to treat, as well as eight other drugs.
According to an AP report, U.S. District Judge Rya Zobel has presided over the case and admitted to being a bit overwhelmed by the figures tossed around in it. The proposed settlement would cover the company’s alleged illegal marketing of the antidepressant drugs Paxil and Wellbutrin for uses that they’ve not been approved to treat. If it’s finalized as such, it will represent the largest health care fraud settlement in U.S. history.
GSK promoted Paxil for the treatment of depression in children and adolescents. They claimed Paxil was safe and effective for pediatric patients. The drug has never been approved to treat patients that young. In fact, there are studies showing that Paxil among younger users greatly increases the risk of suicide.
For Wellbutrin, GSK promoted the popular antidepressant drug for the treatment of attention deficit disorder, bipolar disorder, obesity, sexual dysfunction, and anxiety. Wellbutrin has only been approved to treat depression in adults.
If a doctor prescribes a drug for an off-label use, that is generally considered legal as long as the physician indicates any potential risks to their patients. However, it is illegal for a pharmaceutical company to even hint at using a drug for any purpose other than it’s been approved to treat.
Getting a drug approved to treat a new indication requires extensive pre-market testing that typically costs a drug company millions of dollars just for a chance at getting approved. To circumvent that process, GSK and other companies have opted to skirt the rules and push these drugs for off-label purposes, collecting profits on sales while learning on-the-fly whether it was safe or not.
In addition to those errors, GSK also faced charges that it failed to report to the Food and Drug Administration numerous safety concerns raised with its once-popular type 2 diabetes medication, Avandia. Avandia was once the top-selling diabetes drug available in the U.S until 2010 when domestic regulators drastically restricted access to it because it carried a significant risk of causing heart attack, stroke, and sudden death among people taking it. The drug was outright banned in Europe and only patients in the U.S. who have exhausted all other options and who sign a waiver can get prescriptions for the drug today.
In recent years, the FDA and other federal health authorities have cracked down on illegal marketing of prescription drugs as it is often done at the expense of the Medicare and Medicaid programs.
GSK CEO Sir Andrew Witty told reporters after a hearing to discuss the settlement that his company has learned its lesson “from the mistakes that were made.”