Legal and economic perspectives concerning US government investigations of alleged off-label promotion by drug manufacturers.

Over the past few years, many pharmaceutical manufacturers have settled claims brought by the US Department of Justice (USDOJ) alleging that the drug companies engaged in illegal, off-label product promotion. Between 2003 and 2007, 11 investigations involving off-label promotion in the US were settled. Six of those investigations settled in 2007 alone. In addition, Pfizer Inc. recently announced a reserve in the amount of $US2.3 billion related to the alleged off-label promotion of the cyclo-oxygenase-2 inhibitor Bextra (valdecoxib), as well as issues relating to several other drugs, and Eli Lilly and Company recently settled claims, for approximately $US1.4 billion, that it promoted its atypical antipsychotic drug Zyprexa (olanzapine) for unapproved uses. In this editorial, Paul E.Kalb,MD, JD, and Paul E. Greenberg, MA, MS, offer legal and economic perspectives on the issue.