12 Sep (New England Journal of Medicine) On July 2, 2012, the Department of Justice announced the largest settlement ever in a case of health care fraud in the United States. GlaxoSmithKline (GSK) agreed to plead guilty to three criminal counts and settle civil charges brought under various federal statutes; the company will pay a total of $3 billion to the federal government and participating states. Since 2009, the federal government has collected more than $11 billion in such settlements under the False Claims Act.
In the Federal District Court in Boston a few days later, GSK pleaded guilty to two criminal counts for sales of misbranded Paxil (paroxetine) and Wellbutrin (bupropion). These drugs are considered misbranded when they are promoted for indications for which they have not been approved by the Food and Drug Administration — the practice commonly known as off-label promotion. Providers cannot be reimbursed for misbranded drugs under federal and state rules. GSK also pleaded guilty to a third crime, failing to report safety data related to Avandia (rosiglitazone). Failing to report safety data violates the Food, Drug, and Cosmetic Act and leads to serious questions about whether clinicians are basing their decisions on the best evidence. GSK also settled related civil liabilities for these and other drugs.
For more on this story go to The New England Journal of Medicine