Boehringer Ingelheim's Ridgefield facility by Carol Kaliff
Connecticut Attorney General George Jepsen said Friday Ridgefield-based pharmaceutical Boehringer Ingelheim will pay the states $95 million to settle allegations the company paid kickbacks to doctors to push four drugs, sometimes for uses not approved by the FDA.
A complaint filed in Maryland federal court by a former sales director of the company, alleged that Boehringer and Abbot Labs participated in schemes to improve the sales of these four drugs, providing cash payments to doctors, free equipment and “bogus speaker training” seminars. The complaint further says the companies also paid certain advocacy groups to further claims regarding the drugs.
Connecticut’s Medicaid program is to receive $460,222 and will also receive $107,232 for state-only programs.
According to Jepsen, BI was promoting its stroke prevention drug Aggrenox to treat myocardial infarction and peripheral vascular disease, its hypertension drug Micardis for treatment of early diabetic kidney disease, uses for which the U.S. Food and Drug Administration had not approved them. Also, the states charged BI with marketing Atrovent and Combivent at doses that exceeded those covered by federal health care programs.
BI released the following statement after the announced settlement:
Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) has entered into a settlement agreement with the Department of Justice (DOJ) and the Office of the Inspector General (OIG) of the Department of Health and Human Services to resolve allegations related to the marketing and sales practices of AGGRENOX®, ATROVENT®, COMBIVENT® and MICARDIS® during the years 2000 through 2008.
The company has been cooperating with the government since its investigation began. BIPI decided to resolve this matter in order to avoid the time and expense of continuing litigation. The settlement is civil only and is not an admission of liability by the company.
“The pharmaceutical industry as a whole has undergone significant changes over the past decade and continues to be under intense scrutiny. Likewise, our internal processes and compliance practices have evolved significantly over the years,” said Greg Behar, president and chief executive officer of Boehringer Ingelheim Pharmaceuticals, Inc. “We are confident that the voluntary steps we have taken to enhance our compliance program meet the high standards of ethical behavior, trust and integrity that our patients and customers expect and deserve.”
Under the terms of the agreement, BIPI has agreed to pay approximately $95 million and has also entered into a five-year Corporate Integrity Agreement (CIA). The CIA requires the company to establish certain policies, appoint a Compliance Committee, monitor certain activities and conduct internal training, among other things.
It’s unclear how many doctors were involved in this or whether any face disciplinary actions for taking kickbacks.