Crime in the health-care industry has been a priority of the U.S. Department of Justice for some time. The pharmaceutical industry has received particular attention, especially from federal prosecutors in Main Justice and the District of Massachusetts and Eastern District of Pennsylvania. These offices, and a handful of others, have brought a series of high-profile prosecutions, resulting in corporate guilty pleas and billions of dollars of criminal fines and civil penalties for unlawful “off-label” marketing of prescription drugs—a theory of criminal liability derived from the Food, Drug and Cosmetic Act (FDCA).
When a pharmaceutical company sells a prescription drug, it must first receive approval from the Food and Drug Administration (FDA). The approval of a drug is for a particular medical condition and patient population, and that approval is incorporated in a package insert, or “label”—what consumers may see as the small-print, multi-fold paper inserted into a package that contains the drug. Prescription drugs are often approved for one use, but prescribed by doctors in unapproved doses and for unapproved medical conditions or types of patients.1
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