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Drug company to pay $13.5 million for deceptive promotion of prescription drugs

DrugBoehringer Ingelheim Pharmaceuticals Inc. has agreed to pay $13.5 million to resolve charges it used deceptive marketing that promoted drug usage beyond what’s indicated on the labeling of four of its prescription drugs: Micardis, Aggrenox, Atrovent, and Combivent. The labeling means the prescribing information for health care providers.

The settlement, joined by all 50 states and the District of Columbia, requires BIPI to change its advertising practices.

“Drug companies that misrepresent their products dangerously jeopardize patients’ health in order to increase profits,” New York Attorney General Eric T. Schneiderman said. “Consumers should be able to trust that the advertised benefits of prescription drugs are supported by scientific evidence, not exaggerated claims.”

Aggrenox, a combination of aspirin and dipyridamole, is an antiplatelet drug that was approved by the U.S. Food and Drug Administration in 1999 to reduce the risk of secondary stroke in patients who have had a “mini-stroke” called a transient ischemic attack or TIA. Micardis (Telmisartan) belongs to a class of drugs called angiotensin receptor blockers and is used to treat high blood pressure and to reduce cardiovascular risks in patients not able to take angiotensin-converting-enzyme or ACE inhibitors. Atrovent (ipratropium bromide) and Combivent (ipratropium bromide and albuterol) are bronchodilators used to treat narrowing of the airways associated with chronic obstructive pulmonary disease or COPD.

In a lawsuit filed Wednesday, Schneiderman alleges BIPI misrepresented that:

  • Its antiplatelet drug, Aggrenox, was effective for many conditions “below the neck,” such as heart attacks and congestive heart failure, and that it was superior to Plavix without evidence to prove that claim.
  • Micardis protected patients from early morning strokes and heart attacks, as well as treated metabolic syndrome.
  • Combivent could be used as a first-line treatment for bronchospasms associated with COPD.
  • Atrovent and Combivent could be used at doses that exceeded the maximum dosage recommendation in the product labeling and that they were essential for COPD treatment.   

The settlement requires BIPI to ensure that its marketing and advertising practices don’t unlawfully promote these prescription drug products. BIPI will: 

  • Limit product sampling of the four drugs to health care providers who are following the directions on the product labeling.
  • Stop offering health care providers financial incentives for sales that may be for the unapproved use of any of the four drugs.
    • Ensure unbiased medical information is provided that is separate from promotional materials.
    • Refer requests for unapproved usage information for any of the four drugs to BIPI’s Medical Division.

Comments

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Irene Polka

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