Boehringer Ingelheim Pharmaceuticals Inc. has agreed to 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, the Justice Department announced today.  As a result of today’s $95 million settlement, the federal government will obtain $78 million and state Medicaid programs will obtain $17 million.

The settlement resolves a False Claims Act lawsuit filed in the District of Maryland by Robert Heiden, a former sales representative for Boehringer.  The whistleblower, or qui tam, provisions of the False Claims Act permit the relator to obtain a portion of the proceeds obtained by the federal government. As part of today’s resolution, Heiden will receive more than $17 million.

The US Food and Drug Administration (FDA) has approved Aggrenox to prevent secondary strokes, Combivent to treat continued symptoms of bronchospasm in patients with COPD who already are on a bronchodilator and Micardis to treat hypertension. The settlement resolves allegations that Boehringer improperly marketed each of these drugs and caused false claims to be submitted to government health care programmes.

According to the government’s allegations, Boehreinger promoted each of the three drugs for uses that were not medically accepted indications and were not covered by federal health care programmes. Specifically, the settlement resolves allegations that Boehreinger 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 programmes.

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.

“The improper promotion of pharmaceuticals undermines the FDA’s important role in protecting the American public by determining whether a drug is safe and effective for a particular use before it is marketed,” said Stuart Delery, Acting Assistant Attorney General for the Civil Division.  “Such improper conduct by pharmaceutical companies also causes the government to pay significant amounts for products for which it would not otherwise pay.   This civil settlement by Boehringer demonstrates that such conduct will not be tolerated.”
 
“Pharmaceutical companies cannot market drugs for unapproved uses, make unwarranted claims about their benefits, or pay kickbacks to doctors who prescribe them,” said Rod J. Rosenstein, US  Attorney for the District of Maryland.   “Drugs should be marketed only for purposes for which they are deemed safe and effective, and 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 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.   

“Fraudulent marketing of drugs through off-label promotion and kickbacks to doctors undermines trustworthy medical decision-making, and FDA’s protections in the drug approval process.  “Such conduct -- as alleged in this case -- poorly serves patients and taxpayers alike,” said Daniel R. Levinson, Inspector General of the U.S. Department of Health and Human Services (HHS).  “OIG is overseeing a Corporate Integrity Agreement to improve the transparency of company relationships with physicians and accountability of Board members and corporate executives.”

“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 health care system,” said Ilisa Bernstein, Acting Director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research.