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Boehringer Ingelheim settles with NJ, other states on off-label drug claims

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New Jersey Attorney General Christopher S. Porrino announced on Wednesday the state has entered into a $13.5 million, multi-state settlement that resolves allegations that Boehringer Ingelheim Pharmaceuticals, Inc. unlawfully promoted certain prescription drugs for off-label use and made deceptive claims about the efficacy of those drugs.

The multi-state investigation focused on Boehringer’s marketing and promotion of four brand-name prescription drugs — Aggrenox, Micardis, Combivent and Atrovent — and its allegedly unlawful conduct in carrying out the marketing and promotion effort.

“Anyone who seeks to profit by making misleading or unfounded claims about a prescription drug’s effectiveness, by encouraging consumption of the drug that exceeds recommended dosage, or by making baseless claims of product superiority compared with other drugs is betraying the public trust and, potentially, putting consumers at risk,” said Attorney General Porrino.

Specifically, the states alleged that Boehringer engaged in a course of trade or commerce that constituted unfair, deceptive, and misleading practices by making misrepresentations about the drugs,  and by representing that they had sponsorship, approval, characteristics, ingredients, uses, benefits, quantities, or qualities  they did not have.

For example, the company allegedly misrepresented that its antiplatelet drug, Aggrenox, was effective for treating many conditions “below the neck” such as heart attacks and congestive heart failure, and that it was superior to competing drug Plavix without providing evidence to substantiate that claim.

The states also alleged that Boehringer misrepresented its drugs Micardis Aggrenox, Combivent and Atrovent. Under the settlement terms, the company will: 

•Limit product sampling of the drugs to health care providers whose clinical practice is consistent with the product labeling;

•Refrain from offering financial incentives for sales that may encourage off-label use of any of the 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 the company’s Medical Division.

All 50 states and the District of Columbia are participating in the Boehringer Ingelheim settlement. New Jersey’s share of the multi-state settlement payment is approximately $287,000. Deputy Attorney General Lorraine K. Rak, Chief of the Division of Law’s Consumer Fraud Prosecution Section, handled the Boehringer Ingelheim matter on behalf of the State.

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