TALLAHASSEE, Fla.—Attorney General Pam Bondi and 50 other attorneys general reached a $13.5 million settlement with Boehringer Ingelheim Pharmaceuticals, Inc. regarding alleged off-label marketing and deceptive and misleading representations to promote four prescription drugs. The drugs include Aggrenox®, Atrovent®, Combivent® and Micardis®. The settlement resolves allegations that BIPI engaged in unfair, deceptive or misleading practices by making misrepresentations about the prescription drugs and by representing that the drugs had sponsorship, approval, characteristics, ingredients, uses, benefits, quantities or qualities that they did not have.
Specifically, the states allege BIPI misrepresented that its antiplatelet drug, Aggrenox®, was effective for many conditions below the neck, such as heart attacks and congestive heart failure. Additionally, BIPI claimed Aggrenox® to be superior to Plavix® without evidence to substantiate that claim. BIPI also allegedly misrepresented that Micardis® protected patients from early morning strokes and heart attacks and treated metabolic syndrome. The settlement also resolves allegations that BIPI falsely stated that Atrovent® and Combivent® could be used at doses that exceeded the maximum dosage recommendation in the product labeling.
The consent judgment requires BIPI to ensure 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.
All 50 states and the District of Columbia are participating in the settlement. The settlement is pending judicial approval.
To view a copy of the consent judgment, click here.
