[h=3]By PETER LANDERS And JEANNE WHALEN[/h]WASHINGTON—Pharmaceutical maker GlaxoSmithKline has agreed to plead guilty and pay $3 billion to resolve criminal and civil liability over drug marketing and other issues, the U.S. Department of Justice said Monday.
The Justice Department described the deal as the largest health-care fraud settlement in U.S. history and the largest payment by a drug company.
Getty ImagesA bottle of the diabetes drug Avandia, manufactured by GlaxoSmithKline.
Glaxo said last November that it had agreed to the $3 billion settlement. It said at the time that the $3 billion was covered by provisions the company had taken in recent years as it worked to settle the probes.
The case involves three drugs sold in the U.S. by the British pharmaceutical maker: antidepressants Paxil and Wellbutrin and diabetes drug Avandia.
Glaxo agreed to plead guilty to a three-count criminal information. Among other things, the government alleged that Glaxo unlawfully promoted Paxil for patients under 18 when the drug wasn't approved for those patients.
It also alleged that Glaxo failed to report certain safety data to the Food and Drug Administration regarding Avandia, formerly one of the top-selling diabetes drugs in the world. Avandia now carries black-box warnings about heart risk.
The $3 billion settlement "is a significant step toward resolving difficult, long-standing matters which do not reflect the company that we are today," Glaxo Chief Executive Andrew Witty said in November. "In recent years, we have fundamentally changed our procedures for compliance, marketing and selling in the U.S. to ensure that we operate with high standards of integrity and that we conduct our business openly and transparently."
A number of big drug companies have struck large settlements with the U.S. in recent years to resolve similar investigations. In 2009, Pfizer Inc. agreed to pay $2.3 billion to settle a federal investigation into whether it promoted the painkiller Bextra off label. Eli Lilly & Co. agreed to pay $1.4 billion to settle similar charges involving its antipsychotic medicine Zyprexa.
Write to Peter Landers at [email protected] and Jeanne Whalen at [email protected]
The Justice Department described the deal as the largest health-care fraud settlement in U.S. history and the largest payment by a drug company.
Glaxo said last November that it had agreed to the $3 billion settlement. It said at the time that the $3 billion was covered by provisions the company had taken in recent years as it worked to settle the probes.
The case involves three drugs sold in the U.S. by the British pharmaceutical maker: antidepressants Paxil and Wellbutrin and diabetes drug Avandia.
Glaxo agreed to plead guilty to a three-count criminal information. Among other things, the government alleged that Glaxo unlawfully promoted Paxil for patients under 18 when the drug wasn't approved for those patients.
It also alleged that Glaxo failed to report certain safety data to the Food and Drug Administration regarding Avandia, formerly one of the top-selling diabetes drugs in the world. Avandia now carries black-box warnings about heart risk.
The $3 billion settlement "is a significant step toward resolving difficult, long-standing matters which do not reflect the company that we are today," Glaxo Chief Executive Andrew Witty said in November. "In recent years, we have fundamentally changed our procedures for compliance, marketing and selling in the U.S. to ensure that we operate with high standards of integrity and that we conduct our business openly and transparently."
A number of big drug companies have struck large settlements with the U.S. in recent years to resolve similar investigations. In 2009, Pfizer Inc. agreed to pay $2.3 billion to settle a federal investigation into whether it promoted the painkiller Bextra off label. Eli Lilly & Co. agreed to pay $1.4 billion to settle similar charges involving its antipsychotic medicine Zyprexa.
Write to Peter Landers at [email protected] and Jeanne Whalen at [email protected]