“Today`s agreement sends a strong message to the pharmaceutical industry that the federal government will not tolerate fraudulent activities that compromise the integrity of the health care system,” said Ilisa Bernstein, director of the Compliance Office at the FDA Center for Drug Evaluation and Research. Typical of other large off-label colonies, Boehringer has agreed to conclude a Comprehensive Enterprise Integrity Agreement (CIA) that provides for procedures and verifications to immediately avoid and detect behaviors similar to those that led to the comparison. Inspector General Daniel Levinson said: “OIG is overseeing an agreement on the integrity of the company to improve the transparency of corporate relationships with physicians and the accountability of board members and executives.” In addition, the comparison raises allegations that Boehringer knowingly encouraged the sale and use of combivents and Atrovent in boxes beyond the doses covered by federal health programs, and that Boehringer knowingly made unfounded claims about Aggrenox`s effectiveness, including the fact that it was superior to Plavix. Finally, the agreement includes allegations that the company paid bribes to health professionals to induce them to prescribe Aggrenox, Atrovent, Combivent and Micardis. “The fraudulent marketing of drugs through off-label promotion and kickbacks to physicians undermines trusted medical decision-making and FDA protection in the drug approval process.” Such behaviour – as claimed in this case — serves patients as well as taxpayers,” said Daniel R. Levinson, Inspector General of the U.S. Department of Health and Human Services (HHS). “OIG oversees an agreement on the integrity of the company to improve the transparency of the company`s relationships with physicians and the accountability of board members and executives.” The claims paid by this agreement are merely assertions; no establishing of responsibility. The company must also meet a number of requirements for monitoring and verifying forces on the ground. First, Boehringer must maintain processes that require all stakeholders to undergo training and enter into written agreements decrying the scope of the work to be done, the fees for loudspeakers to be paid and compliance obligations for stakeholders (including requirements that the spokesperson may only use BIPI-approved materials and that the product is not allowed to directly or indirectly promote non-label applications). The Department of Justice`s total recoveries in the False Claims Act cases since January 2009 are more than $13.8 billion and is another product of the government`s Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, announced by Attorney General Eric Holder and Kathleen Sebelius, Secretary of HHS, in May 2009.
Doctors` Payments Reports and Other Transparency While a few months ago since the last major agreement with the off-label promotion of drugs, the Department of Justice and the Office of the Inspector General (OIG) for the Department of Health and Human Services (HHS) recently announced a $95 million comparison with Boehringer Ingelheim Pharmaceuticals Inc (BIPI).