Updated on 5 July 2012
The Department of Justice also investigated the company's marketing and regulatory submissions of Avandia, including GSK's reporting of required information to the US Food and Drug Administration, about post-marketing studies being performed by, or on behalf of, GSK, for Avandia.
GSK entered into a final agreement in November 2011 after cooperating with the Department of Justice in these investigations, and announced that GSK had reached an agreement in principle with the US government to conclude these investigations. The final settlement has now been completed.
The company reached this settlement with the government to avoid the delay, expense, inconvenience and uncertainty of protracted litigation of the government's claims and to put behind us these long-standing investigations of what was, for the most part, very old conduct.
As part of a final agreement, GSK will pay $3 billion to resolve civil and criminal liabilities resulting from these investigations, and the company has also entered into a corporate integrity agreement (CIA), with the US government. The CIA also covers obligations that the company has agreed upon for settling the federal government's investigation of its former manufacturing facility at Cidra, Puerto Rico.