Add two more settlements to the long list of federal and state suits targeting off-label promotion during recent years.
Although promotion of drugs for uses not approved by the FDA continues to be a controversial issue in the industry, the Department of Justice shows no sign of abating enforcement activity. In the last week, we saw settlement announcements in off-label cases against Pfizer (Wyeth) and Boehringer Ingelheim.
On Nov. 1, 2012, Pfizer disclosed in its third-quarter earnings announcement that it was taking a $491 million charge to settle allegations that Wyeth (which Pfizer purchased in 2009) promoted Rapamune for off-label purposes and incentivized prescriptions by providing kickbacks to doctors. The settlement will resolve a long-standing qui tam case that two former Wyeth employees brought in 2005, which the Department of Justice intervened in 2010. The suit alleged that “Wyeth trained and encouraged its sales representatives to market Rapamune”—an immunosuppressant used to prevent the body from rejecting organs after transplant—”for uses outside those listed on the FDA-approved label and to misrepresent and withhold clinical information regarding the safety and efficacy of Rapamune.”
Because Pfizer’s disclosure was based on an “agreement in principle” with the Department of Justice, no further details are available at this time.
Likewise, on October 25, 2012, the Department of Justice announced that it had reached a $95 million agreement with Boehringer Ingelheim Pharmaceuticals Inc. to resolve off-label promotion allegations concerning four of its drugs: stroke-prevention drug, Aggrenox, COPD drugs Atrovent and Combivent, and hypertension drug Micardis. According to the DOJ’s press release, “the settlement resolves allegations that Boehringer promoted Aggrenox for certain cardiovascular events such as myocardial infarction and peripheral vascular disease; that Combivent was marketed for use prior to another bronchodilator in treating COPD; and that Micardis was marketed for treatment of early diabetic kidney disease.” Additionally, the DOJ alleged that Boehringer knowingly promoted treatment with Atrovent and Combivent at doses that exceed those covered by federal healthcare programs, paid kickbacks to doctors to incentivize prescriptions, and made unsubstantiated claims about the efficacy of Aggrenox.
The settlement also concluded a qui tam suit filed by a former Boehringer sales representative in the District of Maryland in 2005. Under the settlement, the federal government obtained approximately $78.5 million and state Medicaid programs obtained $16.5 million. As part of the settlement, Boehringer agreed to enter into an expansive Corporate Integrity Agreement and the relator was awarded more than $17 million under the qui tam provisions of the False Claims Act.
Follow these links to read the DOJ’s press release and Boehringer’s settlement agreement and corporate integrity agreement: