Boehringer Ingelheim has agreed to pay $95 million to resolve allegations in the USA relating to the improper promotion of a number of its older drugs.
The treatments in question are the stroke-prevention drug Aggrenox (extended-release dipyridamole/aspirin), the chronic obstructive pulmonary disease treatments Atrovent (ipratropium bromide) and Combivent (ipratropium/albuterol) and the hypertension drug Micardis (telmisartan), notes the US Justice Department. The government alleged that Boehringer promoted the drugs for uses that were not medically accepted indications and were not covered by federal health care programmes.
The allegations included claims that Aggrenox was promoted for certain cardiovascular events such as myocardial infarction and peripheral vascular disease and was superior to Sanofi/Bristol-Myers Squibb's Plavix (clopidogrel). Combivent was marketed for use prior to another bronchodilator in treating COPD and Micardis was promoted for treatment of early diabetic kidney disease, the DoJ adds.
The settlement resolves a False Claims Act lawsuit filed in Maryland by Robert Heiden, a former sales representative at Boehringer. As part of the resolution, Mr Heiden will receive more than $17 million.
“Pharmaceutical companies cannot market drugs for unapproved uses, make unwarranted claims about their benefits, or pay kickbacks to doctors who prescribe them,” said Rod Rosenstein, US attorney for the District of Maryland. He added that "a doctor’s decision to prescribe a drug should not be influenced by his personal financial interest".
Also as part of the settlement, Boehringer has agreed to enter into a corporate integrity agreement though the Germany-headquartered group stressed that it had not admitted liability. The firm decided to resolve the case to avoid the time and expense of continuing litigation.
The DoJ noted that total recoveries in False Claims Act cases since January 2009 are over $13.80 billion.