The Food and Drug Administration (FDA) has been aggressive in pursuing drug companies and their sales personnel that promoted drugs for off-label uses, or uses that the FDA has not approved.
Both criminal and civil False Claims Act cases have paid off for the government, often lucratively. The record $3 billion penalty that GlaxoSmithKline agreed to pay in July 2012—the largest health care fraud settlement in U.S. history—came in a case that centered on the government’s claims that the drug company promoted several drugs for off-label uses, rendering the products misbranded and thus illegal under the Food, Drug and Cosmetic Act (FDCA). Just months before that, Abbott Laboratories Inc. paid $1.5 billion to resolve criminal and civil charges related to off-label promotion.
