A.G. SCHNEIDERMAN ANNOUNCES $13.5 MILLION MULTI-STATE AGREEMENT WITH BOEHRINGER INGELHEIM PHARMACEUTICALS, INC. FOR DECEPTIVE MARKETING PRACTICES AND PROMOTION OF PRESCRIPTION DRUGS FOR UNAPPROVED USES
Agreement Secures Nearly $500,000 For New York
Pharmaceutical Manufacturer Will End Promotion Of Unauthorized Uses For Prescription Drugs Micardis, Aggrenox, Atrovent, and Combivent
Attorney General Eric T. Schneiderman today announced a $13.5 million agreement with Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI), resolving alleged deceptive and misleading marketing regarding drug usage beyond what is indicated on the labeling of four of its prescription drugs: Micardis®, Aggrenox®, Atrovent®, and Combivent®. The settlement, joined by all 50 states and the District of Columbia, requires BIPI to reform its advertising practices. New York’s share of the settlement is $490,341.
“Drug companies that misrepresent their products dangerously jeopardize patients’ health in order to increase profits,” said Attorney General Schneiderman. “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” known as a Transient Ischemic Attack (TIA). Micardis (Telmisartan) belongs to a class of drugs called angiotensin receptor blockers (ARBs) and is indicated to treat hypertension (high blood pressure) and to reduce cardiovascular risks in patients unable to take angiotensin-converting-enzyme (ACE) inhibitors. Atrovent (ipratropium bromide) and Combivent (ipratropium bromide and albuterol) are bronchodilators indicated to treat bronchospasms (airway narrowing) associated with chronic obstructive pulmonary disease (COPD).
In a complaint filed today in New York County Supreme Court, Attorney General Schneiderman alleges that BIPI: (1) 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 substantiate that claim; (2) misrepresented that Micardis protected patients from early morning strokes and heart attacks, as well as treated metabolic syndrome; (3) misrepresented that Combivent could be used as a first-line treatment for bronchospasms associated with COPD and (4) falsely asserted that 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 do not unlawfully promote these prescription drug products. Specifically, BIPI will:
· Limit product sampling of the four drugs to health care providers whose clinical practice is consistent with treatments indicated on the product labeling;
· Refrain from offering health care providers financial incentives for sales that may indicate unapproved use of any of the four drugs;
· Ensure clinically relevant information is provided in an unbiased manner that is distinct from promotional materials; and
· Refer requests for unapproved usage information regarding any of the four drugs to BIPI’s Medical Division.
The case was handled by Assistant Attorney General Benjamin J. Lee under the supervision of Deputy Bureau Chief Laura J. Levine, Bureau Chief Jane M. Azia in the Consumer Frauds and Protection Bureau, and Executive Deputy Attorney General of Economic Justice Manisha M. Sheth.