In addition to civil allegations to which the company did not admit liability, the corporation did agree to plead guilty to three misdemeanor violations of the U.S. Food, Drug and Cosmetic Act, related to illegal off-label marketing of antidepressants Paxil and Wellbutrin, and failure to disclose the results of certain studies about diabetes drug Avandia.
Paxil and Avandia both had prominent “black box” warnings added to packaging following the conduct.
Between 1998 and 2003 Paxil was marketed by GSK to patients under age 18 despite lacking government approval. Like similar antidepressants, Paxil was eventually found to pose a risk of increased suicidal thoughts and behavior among those under 18, according to documents filed with the settlement. Paxil packages now disclose that risk.
Avandia had a warning added to packaging about potential increased risks of congestive heart failure and heart attack. Investigators said in the settlement that the company between 2001 and 2007 failed to disclose post-marketing safety data about the drug from studies undertaken after European regulators expressed concerns about the drug's cardiovascular safety.
Although GSK said it terminated some employees, company officials were not charged with crimes as part of the settlement.
Robert DeConti, chief of the Administrative and Civil Remedies Branch of HHS' inspector general's office, said in a speech at a health law conference last month that Congress has recently been asking tough questions about personal culpability among company officials in the wake of large settlements.
“They are not satisfied seeing hundred-million-dollar, sometimes billion-dollar settlements,” DeConti said during the annual meeting of the American Health Lawyers Association June 27 in Chicago. “They want to know who's responsible.”
The GSK integrity agreement requires the company to have each member of the board of directors certify regularly that they had made sure the company was implementing an effective compliance program. In addition to implementing new policies and training, a group of top-ranking company officials including the company president must regularly certify that they have taken steps to comply and promote compliance with federal laws.
And the agreement says the company will eliminate “incentive compensation based on territory/individual level sales goals” for sales representatives, and that the company now has the right to recoup or forfeit executive performance pay following certain violations by the executives or other employees.