Boehringer Ingelheim Pharmaceuticals, Inc. (“BIPI”) is the latest pharmaceutical manufacturer to enter into a False Claims Act settlement with the Department of Justice (“DOJ”) predicated on off-label marketing and promotion. Last Friday, October 26, 2012, BIPI agreed to pay $95 million to resolve allegations related to its products Aggrenox, Atrovent, Combivent, and Micardis. At the same time, BIPI entered into an expansive Corporation Integrity Agreement with the Department of Health and Human Services’ Office of Inspector General (“OIG”).
Both the Settlement Agreement and the accompanying Corporate Integrity Agreement contain wrinkles that should be of interest to practitioners and participants in the health care and life sciences field. In particular, the Settlement Agreement’s covered conduct language includes two aggressive allegations; one based on a claim of superiority against a competitor product and the other on promotion of a drug for a covered indication, but at higher than indicated dosages. The Corporate Integrity Agreements contains several of the enhanced provisions previously seen only in the landmark settlements earlier this year with GlaxoSmithKline and Abbott Laboratories, Inc.
The Settlement Agreement (here) describes three types of claims. The first is a traditional off-label allegation, which states that BIPI knowingly promoted the sale and use of its drugs Aggrenox, Combivent, and Micardis for uses for which they had not been approved by the FDA. The government further alleged that certain of the uses for which BIPI promoted these drugs were not medically-accepted indications.
The second type of claim involved allegations related to dosage, and applied only to Medicaid and Federal health care programs other than Medicare. The government alleged that BIPI misrepresented its bronchodilator drug Atrovent as a more cost-effective alternative to its competitors based on its labeled dosage information, but actually marketed the drug at doses in excess of its label. The government also alleged that BIPI promoted the COPD drug Combivent at dosages that exceed those covered by Medicaid and Federal health care programs other than Medicare.
The careful delineation of conduct alleged to cause harm to the Medicare program versus the conduct that harmed other Federal health care programs and Medicaid suggests that the former program would, in some instances, have paid for Atrovent and Combivent even if they had known about the allegedly improper conduct. For example, the Settlement Agreement language implies that Medicare would have agreed to cover Atrovent and Combivent even at higher-than-indicated dosages. This distinction between the Medicare program and other Federal health care programs may mean that State Medicaid programs will continue to play an increasingly important role in off-label investigations.
The third type of allegation involves a claim of superiority. The government alleged that BIPI knowingly made false representations or statements that Aggrenox was superior to Plavix, its primary competitor, even though BIPI lacked clinical evidence to support that claim. Liability in False Claims Act cases has only infrequently turned on superiority claims, most notably in the Elan Pharmaceuticals case. (described here)
The covered conduct also included Anti-Kickback Statute allegations of the type that are routinely found in off-label promotion cases. More specifically, the government’s intervention complaint alleged that BIPI used advisory boards, speaker programs, speaker training programs, and consulting agreements to induce physicians to promote and prescribe the drugs at issue.
The Corporate Integrity Agreement (“CIA”) (here) is the first to be entered into in connection with off-label conduct subsequent to the enhancements contained in the recent landmark GSK and Abbott Laboratories cases. The expansive nature of the BIPI CIA suggests that OIG intends to add certain provisions to its arsenal of oversight best practices. These provisions include provisions government compensation practices, management accountability and certifications, compendia submissions, sponsorship of post-marketing clinical trials, and transparency around authorship of journal articles.
This settlement calls into question suggestions voiced by commentators in recent years that DOJ, FDA, and OIG are nearing the end of their stepped-up enforcement of off-label marketing and promotion. Indeed, the appearance of new theories of liability and stronger oversight provisions suggest that the government is continuing to expand its enforcement efforts.