Pharma company to pay $95 million in settlement for 'off-label' drug promotion

A pharmaceutical company will pay $95 million over allegations of kickbacks regarding three medications used in skilled nursing facilities and hospitals.

Boehringer Ingelheim Pharmaceuticals manufactured the drugs: Aggrenox, used to prevent strokes; Combivent, used to treat Chronic Obstructive Pulmonary Disease; and Micardis, used to treat high blood pressure. The Department of Justice says Boehringer engaged in “off-label marketing” of the drugs.

The Food and Drug Administration has approved Aggrenox to prevent secondary strokes, Combivent to treat symptoms of bronchospasm in patients with COPD who already are on a bronchodilator, and Micardis to treat hypertension, the Department of Justice said.

The federal share of the civil settlement is more than $78 million; and the state Medicaid share is $16.5 million. The case was brought by a whistleblower in Maryland under the False Claims Act. That individual will receive $17 million from the federal share of the civil recovery.

The settlement reflects an increased interest of state and federal government in examining pharmaceutical companies and pharmacies distributing drugs for off-label use.