The United States Justice Department has fined British drug company GlaxoSmithKline $3 billion for failing to accurately report safety data related to two of its most popular drugs, Wellbutrin and Paxil. The fine is divided – $2 billion to resolve the largest fraud settlement in U.S. history and $1 billion to resolve criminal charges brought against the company, to which the company will plead guilty.
GSK will plead guilty to marketing drugs for treatment for conditions for which they had not been approved by the government. Paxil was marketed to children, when it had been approved only for treatment of depression and anxiety in adults. Wellbutrin was being marketed as a weight-loss aid, when it had been approved as an antidepressant. In addition, GSK failed to report safety data regarding Avandia, used in the treatment of diabetes, after it was linked to heart-related issues in users.
“Today’s multibillion-dollar settlement is unprecedented in both size and scope,” said James M. Cole, the deputy attorney general. “It underscores the administration’s firm commitment to protecting the American people and holding accountable those who commit health care fraud.”
The Department of Health and Human Services and GSK have also reached a five-year agreement regarding compliance with federal guidelines. GSK was accused of paying doctors to attend medical conferences at which they promoted uses for the drugs that were not approved by the Food and Drug Administration.
The agreement still needs court approval.