GlaxoSmithKline (GSK) misbranded Wellbutrin and Paxil and failed to alert the Food and Drug Administration (FDA) about safety issues related to Avandia, which resulted in criminal charges against the pharmaceutical giant. The Justice Department recently announced that GSK has agreed to plead guilty to three criminal charges. The fine for its bad acts, $3 billion, is the largest ever paid by a drug manufacturer.
One billion of the $3 billion penalty is a criminal fine; the remaining $2 billion will resolve claims made against the drug maker under the False Claims Act. Government regulators will also oversee GSK for five years to monitor for any continued or additional violations.
The Department of Justice considers the bad acts of GSK to be health care fraud and pledges to do everything it can to protect consumers from the risks associated with drug companies who violate FDA and other regulations.
GSK was guilty of off-label marketing, the practice of promoting a drug for a use not yet approved by the FDA. Paxil was promoted for treating children suffering from depression, but the FDA had only approved its use in individuals 18 and older. Wellbutrin was marketed as a weight loss drug and for treatment of sexual dysfunction, addiction and attention deficit disorder (ADD), but FDA approval was limited to only the treatment of major depression.
The fine is in addition to the more than $700 million GSK has set aside to settle lawsuits with patients who suffered serious side effects from taking Avandia. Avandia was found to increase the risk of stroke and heart attack among diabetes patients taking the drug.
Source: USA Today, "Drug giant pleads guilty, fined $3B for drug marketing," July 2, 2012