Boehringer Ingelheim has agreed to pay $95m to settle claims it marketed several drugs in the US for unapproved uses.
The US Department of Justice said that the German pharma company had been involved in the “improper promotion" of the stroke-prevention drug Aggrenox, the chronic obstructive pulmonary disease (COPD) drugs Atrovent and Combivent, and the hypertension drug Micardis.
These allegations stemmed from former Boehringer sales rep, Robert Heiden, who will receive more than $17m under the provisions of the False Claims Act for acting as a whistleblower.
This money comes from the $78.5m Boehringer is to pay the federal government, from which state Medicaid programmes will receive $16.5m.
Heiden called out Boehringer for promoting Aggrenox for cardiovascular events such as myocardial infarction and peripheral vascular disease, neither of which are part of the drug's approved marketing indications from the Food and Drug Administration (FDA).
In addition, Boehringer is also said to have marketed Combivent for use prior to another bronchodilator in treating COPD, and promoted Micardis for the treatment of early kidney disease in people with diabetes.
As well as these claims of improper marketing of drugs in unapproved uses, the Department of Justice said Boehringer “knowingly promoted the sale and use of Combivent and Atrovent at doses that exceeded those covered by federal health care programmes and that Boehringer knowingly made unsubstantiated claims about the efficacy of Aggrenox, including that it was superior to Plavix”.
On top of all this, the settlement also resolves allegations that Boehringer paid kickbacks to physicians to encourage the prescribing of all the mentioned drugs.
“The improper promotion of pharmaceuticals undermines the FDA's important role in protecting the American public by determining whether a drug is safe and effective for a particular use before it is marketed,” said Stuart Delery, acting assistant attorney general for the civil division of the Department of Justice.
“This civil settlement by Boehringer demonstrates that such conduct will not be tolerated.”
Boehringer told Reuters the decision to settle was not an admission liability, but was made “to resolve this matter in order to avoid the time and expense of continuing litigation”.
As well as the $95m settlement, Boehringer has also agreed to enter a 'corporate integrity agreement' overseen by the Departmenrt of Justice. This will ensure procedures and reviews are implemented within Boehringer to both avoid and detect similar improper marketing conduct in the future.