Boehringer Ingelheim Pharmaceuticals Inc. will pay $95 million to settle allegations that the company promoted three drugs for uses that were not medically accepted, the government announced Thursday.
The Justice Department said the three are the stroke-prevention drug Aggrenox, the chronic obstructive pulmonary disease drug Combivent and the high-blood-pressure drug Micardis.
The Justice Department said the company also promoted the use of a fourth drug, Atrovent, at doses exceeding those covered by federal health care programs. Atrovent also is used to treat chronic obstructive pulmonary disease.
Finally, the settlement resolved allegations that Boehringer Ingelheim paid kickbacks to health care professionals to induce them to prescribe all four of the drugs. These kickbacks included payments for participating in advisory boards, speakers' training programs, speaker programs and consultant programs.
Thursday's announcement is the latest in a series of settlements with pharmaceutical companies engaging in so-called off-label marketing. In the law enforcement initiative's biggest case, GlaxoSmithKline agreed to pay $3 billion and pleaded guilty to promoting two popular drugs for unapproved uses and to failing to disclose important safety information on a third.
"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, the U.S. Attorney for 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."
The Food and Drug Administration has approved Aggrenox to prevent secondary strokes, Combivent to treat bronchospasm in patients with chronic obstructive pulmonary disease who already are on a bronchodilator and Micardis to treat high blood pressure.
But the government alleged that the company also promoted Aggrenox for myocardial infarction and peripheral vascular disease, Combivent for use prior to using a bronchodilator and Micardis for treatment of early diabetic kidney disease. The Justice Department said that because those uses were not medically accepted, they were not eligible for reimbursement by federal health care programs.
The company also agreed as part of the settlement to impose new internal procedures and reviews to promptly detect any recurrence of such activity.
"The pharmaceutical industry as a whole has undergone significant changes over the past decade and continues to be under intense scrutiny," said Greg Behar, president and chief executive officer of Boehringer Ingelheim. "Likewise, our internal processes and compliance practices have evolved significantly over the years." The company said it has been cooperating with the government investigation.
The Ridgefield, Conn.-based company said it agreed to the civil settlement to avoid the time and expense of continuing litigation but that the settlement was not an admission of liability by the company.
The federal government will receive more than $78 million under the settlement, and state Medicaid programs will receive over $16 million.
The settlement resolves a False Claims Act lawsuit filed in federal court in Maryland by Robert Heiden, a former sales representative for Boehringer. The law allows private whistle-blowers like Heiden to share in any money collected by the federal government as a result of the whistle-blower's bringing questionable conduct to light. Heiden will receive more than $17 million from the federal government's $78 million share of the settlement.