Boehring Ingelheim Pharmaceuticals will pay $95 million to settle allegations that it promoted three of its drugs for uses that were not approved by the Food and Drug Administration (FDA). The three drugs are the stroke-prevention drug Aggrenox, the chronic obstructive pulmonary disease drug Combivent, and the hypertension drug Micardis. The Justice Department also said Boehring Ingelheim promoted the use of the chronic obstructive pulmonary disease drug Atrovent at doses higher than what was approved by drug regulators.
The settlement with Boehring Ingelheim also resolved allegations that the drug company paid kickbacks to health care professionals to entice them to prescribe the four drugs in question.
Doctors have the discretion to prescribe drugs for off-label uses, but pharmaceutical companies are forbidden to market drugs for uses other than those approved by the FDA. The agency has made prosecuting drug companies that violate this rule a focus in recent years.
The settlement adds more pressure for Boehring Ingelheim. The drug company is currently facing numerous lawsuits over its blood thinner Pradaxa. The FDA approved the drug in 2010 to prevent strokes in patients with a common heart condition called atrial fibrillation. It was the first drug for this indication since warfarin was approved more than 50 years ago.
Within 14 months of Pradaxa’s approval, the FDA received thousands of adverse event reports associated with the new blood thinner, including 900 cases of gastrointestinal bleeds and 500 cases of bleeding deaths.