The state of Colorado will receive $221,430 as part of a settlement against Connecticut-based pharmaceutical manufacturer Boehringer Ingelheim Pharaceuticals Inc. for alleged kickbacks and off-labeling market campaigns, said Attorney General John Suthers.
The state will return about $104,000 to the federal government for its share of the Medicaid money recovered in the settlement. Nationally, BIPI will pay the federal and state governments about $95 million, about $34 million returned to state Medicaid programs. Colorado spends more than $4.5 billion a year for Medicaid expenses.
“These funds represent another significant recovery for Colorado’s Medicaid program,” said Suthers. “Coupled with other recently announced drug settlement cases, pharmaceutical companies should be on notice that Colorado will not tolerate pharmaceutical companies breaking the rules and increasing the burden on important state programs that benefit children, the sick and those most in need.”
The settlement resolves allegations that BIPI unlawfully marketed the drugs Aggrenox, Combivent, Atrovent and Micardis for a variety of reasons not approved by the Food and Drug Administration. These included Aggrenox for certain cardiovascular events such as myocardial infarction and peripheral vascular disease; Combivent for use prior to another bronchodilator in treating Chronic Obstructive Pulmonary Disease; and Micardis for treatment of early diabetic kidney disease. The agreement also resolves allegations that the company paid kickbacks to health care professionals as inducement to prescribe.
While physicians are generally free to prescribe FDA-approved drugs for “off-label” uses, with few exceptions drug manufacturers are not permitted to directly promote or market their drugs for such uses. Moreover, Colorado and other Medicaid programs usually do not pay for prescriptions for off-label purposes.
The settlement resolves a whistleblower lawsuit filed in the United States District Court for the District of Maryland under the federal False Claims Act and parallel state statutes.