Connecticut-based Boehringer Ingelheim Pharmaceuticals Inc. has agreed to pay $95 million to resolve allegations relating to the improper promotion of the stroke-prevention drug Aggrenox, the chronic obstructive pulmonary disease (COPD) drugs Atrovent and Combivent, and the hypertension drug Micardis, the Justice Department announced today.
The Food and Drug Administration (FDA) has approved Aggrenox to prevent secondary strokes, Combivent to treat continued symptoms of bronchospasm in patients with COPD who already are on a bronchodilator and Micardis to treat hypertension. The settlement resolves allegations that Boehringer improperly marketed each of these drugs and caused false claims to be submitted to government health care programs.
According to the government’s allegations, Boehreinger promoted each of the three drugs for uses that were not medically accepted indications and were not covered by federal health care programs. Specifically, the settlement resolves allegations that Boehreinger promoted Aggrenox for certain cardiovascular events such as myocardial infarction and peripheral vascular disease; that Combivent was marketed for use prior to another bronchodilator in treating COPD; and that Micardis was marketed for treatment of early diabetic kidney disease. The uses were not for medically accepted indications and were not covered by federal health care programs.
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