Boehringer Ingelheim Pharmaceuticals will 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 (telmisartan), according to the Justice Department.
The government charged Boehringer with promoting the drugs for uses that were not medically accepted indications and were not covered by federal healthcare programs. Specifically, the settlement resolves allegations that Boehringer promoted Aggrenox for certain cardiovascular events such as MI 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 settlement also resolves allegations that Boehringer knowingly promoted the sale and use of Combivent and Atrovent at doses that exceeded those covered by federal healthcare programs and that Boehringer knowingly made unsubstantiated claims about the efficacy of Aggrenox, including that it was superior to Plavix (clopidogrel, Bristol-Myers Squibb/Sanofi-Aventis). Finally, the agreement resolves allegations that the company paid kickbacks to healthcare professionals to induce them to prescribe Aggrenox, Atrovent, Combivent and Micardis.
The settlement allocates $78.5 million to the federal government and $16.5 million to state Medicaid programs. The settlement resolves a False Claims Act lawsuit filed in the District of Maryland by Robert Heiden, a former sales representative for Boehringer. As part of the resolution, Heiden will receive more than $17 million.
Also as part of the settlement, Boehringer has agreed to enter into an expansive Corporate Integrity Agreement that provides for procedures and reviews to be put in place to avoid and promptly detect conduct similar to that which gave rise to the settlement.
“Today’s settlement sends a strong message to the pharmaceutical industry that the federal government will not tolerate fraudulent activity which undermines the integrity of the healthcare system,” said Ilisa Bernstein, acting director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, in a release.
Boehringer’s U.S. unit is based in Ridgefield, Conn. The claims settled by this agreement are allegations only; there has been no determination of liability.