Boehringer Ingelheim Corporate Integrity Agreement

First, Boehringer must maintain processes to require all stakeholders to undergo training and enter into written agreements describing the amount of work to be done, the speaker fees to be paid, and the compliance obligations for stakeholders (including requirements that the spokesperson may only use bipi authorized materials and may not promote the product directly or indirectly for off-label purposes). In addition, the comparison clarifies claims that Boehringer knowingly encouraged the sale and use of Combivent and Atrovent at doses higher than those covered by federal health programs and that Boehringer knowingly made unfounded claims about the efficacy of Aggrenox, including the superiority of Plavix. “Today`s comparison sends a strong message to the pharmaceutical industry that the federal government will not tolerate any fraudulent activity that undermines the integrity of the healthcare system,” said Ilisa Bernstein, acting director of the Office of Compliance at the FDA`s Center for Drug Evaluation and Research. According to the government`s accusations, Boehreinger encouraged each of the three drugs for applications that were not medically accepted indications and were not covered by federal health programs. In particular, the comparison clarifies claims that Boehreinger Aggrenox contributed to certain cardiovascular events such as myocardial infarction and peripheral vascular disease; whereas Combivent has been marketed for use in front of another bronchodilator for the treatment of COPD; and that Micardis has been marketed for the treatment of previous diabetic kidney disorders.. . . .

2 weeks ago