Rutledge Reaches Settlement with Boehringer Ingelheim Pharmaceuticals
December 21, 2017
Says, ‘Arkansans should be able to trust that the medications they are being prescribed will help cure their ailments’
LITTLE ROCK – Arkansas Attorney General Leslie Rutledge has reached a settlement, along with attorneys general from all other states and the District of Columbia, with Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI). The settlement ends a multistate investigation into BIPI’s alleged off-label marketing, deceptive and misleading representations made in its promotion of four of its prescription drugs: Micardis®, Aggrenox®, Atrovent®, and Combivent®.
“Arkansans should be able to trust that the medications they are being prescribed will help cure their ailments,” said Attorney General Rutledge. “But the deceptive advertising practices of Boehringer Ingelheim Pharmaceuticals calls those prescriptions into question and puts Arkansans at risk of taking medications that will not help them.”
Arkansas will receive $175,298.58 of the $13.5 million settlement, which will be deposited into the Consumer Education and Enforcement Fund. The settlement resolves allegations that BIPI engaged in a course of trade or commerce that constitutes unfair, deceptive, or misleading practices, by making misrepresentations about the above-mentioned prescription drugs and by representing that the prescription drugs had sponsorship, approval, characteristics, ingredients, uses, benefits, quantities, or qualities that they did not have. Specifically, the States allege BIPI: (1) misrepresented that its antiplatelet drug, Aggrenox®, was effective for many conditions “below the neck,” such as heart attacks and congestive heart failure, and that it was superior to Plavix® without evidence to substantiate that claim; (2) misrepresented that Micardis® protected patients from early morning strokes and heart attacks and treated metabolic syndrome; (3) misrepresented that Combivent® could be used as a first-line treatment for bronchospasms associated with chronic obstructive pulmonary disease (COPD); and (4) falsely stated that Atrovent® and Combivent® could be used at doses that exceeded the maximum dosage recommendation in the product labeling and that they were essential for treatment of COPD.
The Consent Judgment requires BIPI to ensure that its 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.
Kansas and Pennsylvania led the Executive Committee, which also includes Attorneys General from Arizona, District of Columbia, Illinois, Indiana, Nevada, Tennessee and Texas.
All 50 states and the District of Columbia are participating in the settlement.