GlaxoSmithKline was slapped with a $3 billion fine Monday by the U.S. Justice Department after failing to report safety data on some of the company’s most popular drugs.
The payment — with $1 billion going to settle criminal wrongdoing, and $2 billion to cover civil liabilities — is the largest fraud settlement in U.S. history, and the largest payment ever by a drug company.
The settlement “underscores the administration’s firm commitment to protecting the American people and holding accountable those who commit health care fraud.” James M. Cole, a deputy attorney general, said in a statement.
GlaxoSmithKline will plead guilty to two counts of introducing misbranded drugs, Paxil and Wellbutrin, into interstate commerce.
Specifically, the government alleges that the drugs were marketed as a treatment for conditions for which they had not been approved.
The drug company markets Wellbutrin as an antidepressant and Paxil as a treatment for depressive and anxiety disorders.
A third count involves a failure to report safety data about the drug Avandia, a diabetes drug, to the Food and Drug Administration between 2001and 2007.
GlaxoSmithKline said in a statement that the settlement will be funded through existing cash resources.
“On behalf of GSK, I want to express our regret and reiterate that we have learnt from the mistakes that were made,” CEO Andrew Witty said in a statement, adding that the company has changed its procedures for compliance, marketing and selling since the incidents.
–CNN’s Terry Frieden contributed to this report
