CIA

Seven years after the biggest drug safety scandal since thalidomide was found to cause birth defects, Merck and the Justice Department announced a nearly $1 billion settlement of litigation over Vioxx, the Cox-2 pain drug found to cause strokes and heart attacks.

Novartis's recent off-label settlement with the Department of Justice -- to the tune of $422 million -- also included the signing of a Corporate Integrity Agreement (CIA) requiring the Swiss-based manufacturer to review incentive-based compensation for reps, and to examine "the extent to which compensation is based on product performance," according to the CIA.

As part of an $81 million off-label settlement with the Department of Justice (DOJ), Ortho-McNeil Janssen Pharmaceuticals Inc. (OMJPI) sales reps will be buddied up with internal compliance monitors tasked with observing and reporting the rep's behavior out in the field.