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Boehringer Ingelheim to pay $95M in settlement

Associated Press Modified: October 25, 2012 at 5:03 pm •  Published: October 25, 2012

WASHINGTON (AP) — 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.

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