All 50 states and the District of Columbia have reached a $13.5 million settlement with Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) regarding its alleged off-label marketing and deceptive and misleading representations made in its promotion of four of its prescription drugs: Micardis,® Aggrenox,® Atrovent,® and Combivent.®
Due to a change in Arizona law, the Arizona settlement does not include certain injunctive terms related to off-label marketing.
The settlement resolves allegations that BIPI engaged in a course of trade or commerce that constitutes unfair, deceptive or misleading practices, by making misrepresentations about the aforementioned prescription drugs and by representing that the prescription drugs had sponsorship, approval, characteristics, ingredients, uses, benefits, quantities or qualities that they did not have.
Specifically, the States allege 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 and treated metabolic syndrome; (3) misrepresented that Combivent® could be used as a first-line treatment for bronchospasms associated with chronic obstructive pulmonary disease (COPD); and (4) falsely stated 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 treatment of COPD.
The Consent Judgment requires BIPI to ensure that its marketing and promotional 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 the product labeling;
Refrain from offering financial incentives for sales that may indicate off-label use of any of the four drugs;
Ensure clinically relevant information is provided in an unbiased manner that is distinct from promotional materials; and
Provide that requests for off-label information regarding any of the four drugs are referred to BIPI’s Medical Division.