The terms “off-label promotion” and “off-label marketing” have been pejorative terms in the government and the life-sciences community for years. Recent developments have questioned the scope of the First Amendment’s right of free speech and are pressure-testing the enforcement environment in the off-label-promotion arena.
Historically, pharmaceutical companies faced the dual threat of criminal and civil prosecution for off-label promotion of Food and Drug Administration (FDA) approved drugs (off-label promotion is the promotion of drugs for uses that have not received FDA approval). For the past two decades, the Department of Justice (DOJ) aggressively pursued parallel civil and criminal investigations that resulted in massive settlements as companies sought to avoid prosecution under the Food, Drug & Cosmetic Act (FDCA), large damage awards under the False Claims Act (FCA) and, worst of all, potential exclusion from federal health-care programs, the “death knell” to life-sciences companies operating in in United States. See e.g. DOJ settlements resolving civil/criminal liability for off-label marketing including: 2012 $3 billion settlement with GlaxoSmithKline (Paxil, Wellbutrin, Advair); 2009 $2.3 billion settlement with Pfizer (Bextra, Geodon, Zyvox and Lyrica); and 2012 $1.5 billion settlement with Abbott Laboratories (Depakote).