Baltimore, Maryland – Maryland Attorney General Brian E. Frosh announced today that Maryland has joined 49 other states and the District of Columbia in reaching a $13.5 million settlement with Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) over allegations of illegal marketing of four of its prescription drugs: Aggrenox, Micardis, Atrovent, and Combivent.
The settlement resolves allegations that BIPI misrepresented that (1) its antiplatelet drug, Aggrenox, was appropriate to treat certain cardiovascular conditions and that it was superior to a competing drug, when it lacked evidence to substantiate such claims; (2) its hypertension drug, Micardis, was appropriate to treat certain conditions and that it was superior to competing drugs, when it lacked evidence to support such claims; (3) Combivent could be used as a first-line treatment for bronchospasms associated with chronic obstructive pulmonary disease (COPD); and (4) Atrovent and Combivent could be used at doses that exceeded the maximum dosage recommendations in the products’ labeling.
“Drug marketing must be based on sound science and FDA approval, not the overblown claims of pharmaceutical companies,” said Attorney General Frosh. “Misrepresenting information about prescription drugs puts at risk the health of vulnerable patients, young and old alike.”
The Final Judgment and Consent Order requires BIPI to ensure that its marketing and promotional practices do not unlawfully promote these prescription drug products. Specifically, BIPI will refrain from making any false, misleading, or deceptive claims about any of the four drugs, and for five years, BIPI will:
- Limit product sampling of each of the four drugs to health care providers whose clinical practices are consistent with the product’s 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;
- Refrain from promoting the four drugs for any off-label use; and
- Provide that requests for off-label information regarding any of the four drugs are referred to BIPI’s Medical Division.
The press release is available at marylandattorneygeneral.gov.