Boehringer Ingelheim (BI) has agreed to pay $95 million to settle allegations that it improperly promoted the stroke-prevention drug Aggrenox (aspirin and extended-release dipyridamole), the chronic obstructive pulmonary disease drugs Atrovent (ipratropium) and Combivent (ipratropium and albuterol), and the hypertension drug Micardis (telmisartan).
According to an Oct. 25, 2012, US Justice Department press release, the government alleges that BI improperly promoted each of the drugs for uses that were not medically accepted indications and that were not covered by federal healthcare programs. Specifically, the settlement resolves allegations that BI promoted Aggrenox for certain cardiovascular events such as myocardial infarction and peripheral vascular disease; that Combivent was marketed for use before another bronchodilator in treating COPD; and that Micardis was marketed for treatment of early diabetic kidney disease.
In addition, the settlement resolves allegations that BI promoted the sale and use of Combivent and Atrovent at doses that exceeded those covered by federal healthcare programs and that BI made unsubstantiated claims about the efficacy of Aggrenox. Finally, the agreement resolves allegations that the company paid kickbacks to healthcare professionals to induce them to prescribe Aggrenox, Atrovent, Combivent, and Micardis.
As a result of the settlement, the federal government will receive $78,455,048, and state Medicaid programs will receive $16,544,952. BI has also agreed to enter into a corporate integrity agreement that provides for procedures and reviews to be put in place to avoid and detect conduct similar to that which gave rise to the settlement. According to the Justice Department, the claims settled by this agreement are allegations only; there has been no determination of liability.