Boehringer Ingelheim to pay $95 million to resolve False Claims Act allegations in USA

The US subsidiary of independent German drug major Boehringer Ingelheim has agreed to pay $95 million to resolve allegations under the False Claims Act relating to the improper promotion of the stroke-prevention drug Aggrenox (aspirin/extended-release dipyridamole), the chronic obstructive pulmonary disease (COPD) drugs Atrovent (ipratroprium) and Combivent (ipratropium bromide and salbutamol, and the hypertension drug Micardis (telmisartan), the US Justice Department announced last week.

According to the government’s allegations, Boehringer 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 Boehringer 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

Additionally, the settlement resolves allegations that Boehringer knowingly promoted the sale and use of Combivent and Atrovent at doses that exceeded those covered by federal health care programs and that Boehringer knowingly made unsubstantiated claims about the efficacy of Aggrenox, including that it was superior to Plavix. Finally, the agreement resolves allegations that the company paid kickbacks to health care professionals to induce them to prescribe Aggrenox, Atrovent, Combivent and Micardis.