GlaxoSmithKline Pleads Guilty in Largest US Health Care Fraud Ever

July 3, 2012

Pharmaceutical giant GlaxoSmithKline has agreed to plead guilty and pay $3-billion to settle claims that it unlawfully promoted several prescription drugs for uses that were not approved by the FDA.  The drugs which were improperly marketed for off-label use include Paxil, Wellbutrin and Avandia.

The promotion included lavish gifts to doctors to get them write prescriptions for the drugs.  The Justice Department announced that the misuse of these drugs caused patient harm and undoubtedly deaths. Click here to watch this report by ABC News.

This multi-billion dollar settlement represents the largest penalty for alleged health care fraud in US history, with GlaxoSmithKline pleading guilty to three criminal charges for disregarding regulations under the False Claims Act.

One infraction included advertising the drug Paxil, or it’s generic brand Paroxetine, for treatment of depression in children, ignoring the FDA’s non-approval for use by anyone under the age of 18.

A notice posted on the website for the U.S. National Library of Medicine warned that a small number children and young adults “became suicidal,” after using the anti-depressant.

Last year, when the government first approached GSK regarding the accusations, they responded by saying that the company has “fundamentally changed our procedures for compliance, marketing and selling in the USA to ensure that we operate with high standards of integrity and that we conduct our business openly and transparently.”

The settlement is the culmination of an extensive investigation involving the FDA, FBI and Department of Health and Human Services.