Drug giant GlaxoSmithKline LLC. has agreed to plead guilty to alleged drug marketing malfeasance and to pay $3 billion in fines, making the case the largest U.S. health care fraud settlement in history and the most money ever paid by a drug company to resolve federal charges, the Department of Justice announced Monday.

The DOJ said the pharmaceutical firm will plead guilty to three counts of criminal information for alleged off-label marketing of the antidepressants Paxil and Wellbutrin, and for allegedly withholding safety information from the Food and Drug Administration for its diabetes drug Avandia.

"Health care fraud is an epidemic that touches every aspect of our lives," Stuart F. Delery, acting assistant Attorney General for the Civil Division of the DOJ, said at a press conference revealing the settlement Monday morning. "And yet, for far too long, we have heard that the pharmaceutical industry views these settlements merely as the cost of doing business."
According to the DOJ, GlaxoSmith Kline will pay nearly $1 billion in fines and forfeitures, and another $2 billion to resolve civil allegations for off-label drug promotions, paying physicians kickbacks to prescribe certain drugs and for underpaying rebates to a Medicaid program. The off-label settlement, which also includes alleged illegal, unapproved promotions for anti-epileptic, asthma and post-operative nausea drugs, resolves four pending whistleblower lawsuits in the District of Massachusetts, the DOJ said.

On top of the historically hefty fines, GlaxoSmithKline also has inked a five-year Corporate Integrity Agreement with the Department of Health and Human Services' office of the inspector general, to change the way it does business. In particular, it removes compensation for the company's sales force based on sales goals for territories, "one of the driving forces behind much of the conduct at issue in this matter," the DOJ said. The agreement also authorizes the company to take back bonuses or financial incentives paid to employees, or even ex-employees, who are found to engage in "significant misconduct."

GlaxoSmithKline's guilty plea and sentence aren't final until approved by a district court, the DOJ said.

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