States Skewer Drugmaker on ‘Below-the-Neck’ Marketing Claims

MADISON, Wis. (CN) – A drugmaker that made vague claims about its pills being effective for “below-the-neck” conditions struck a $13.5 million settlement Wednesday with 51 state attorneys general.

Led by Wisconsin Attorney General Brad Schimel, the states accused Germany-based Boehringer Ingelheim Pharmaceuticals of misleading consumers with its off-label marketing of Aggrenox, Micardis, Combivent and Atrovent, all prescription drugs.

Aggrenox, a blood thinner made with aspirin and dipyridamole, is the drug that was touted as effective for conditions “below the neck,” including heart attacks and congestive heart failure.

BIPI, as the drugmaker’s name is abbreviated in the settlement announcement, called Aggrenox better than Plavix but lacked evidence to substantiate the claim, Schimel said.

Micardis is indicated for hypertension management, but the attorneys general say BIPI made misleading claims about its ability to protect against early-morning strokes and heart attacks.

The other two drugs meanwhile were allegedly misrepresented as successful treatments for the lung disorder COPD, short for chronic obstructive pulmonary disease.

Wednesday’s settlement requires BIPI to ensure that its marketing practices do not unlawfully promote the four prescription drugs.

In addition to payments to all 50 states and the District of Colombia that brought the case, the settlement sets some rules for the company to ensure appropriate promotional practices including limiting product sampling to health care providers whose clinical practice is related to the product labeling.

Boehringer spokeswoman Erin Crew said the company has not admitted to any wrongdoing, just as it did not when it settled with the federal government and some states in 2012 over essentially the same conduct.

“The period during which the alleged conduct occurred ended in 2008, and most allegations are now more than a decade old,” Crew said in a statement.

“We have agreed to the settlement to avoid the costs associated with a further prolonged legal process related to these allegations,” Crew added.

A spokesman for Schimel’s office declined to comment beyond Schimel’s statement.

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