Over the last decade, the government has extracted billions of dollars from pharmaceutical manufacturers to resolve "off-label" drug promotion investigations. Pharmaceutical manufacturers have strong incentives to resolve such investigations, given the substantial penalties and disabilities that result from being indicted, let alone convicted, including the threat of exclusion from federal health care programs such as Medicare and Medicaid. The government’s central theory in many of these cases is that it is unlawful for companies to promote FDA-approved drugs for unapproved, or "off-label," uses, even though doctors may lawfully prescribe these drugs for the same unapproved uses.1
But no federal statute expressly criminalizes the promotion of prescription drugs for "off-label" uses. Rather, the Food, Drug, and Cosmetic Act (FDCA) makes criminal "[t]he introduction or delivery for introduction into interstate commerce of any…drug…that is misbranded."2 A drug is misbranded if, inter alia, its labeling fails to bear "adequate directions for use,"3 which the FDA defines by regulation as "directions under which the lay[person] can use a drug safely and for the purposes for which it is intended."4 The regulations recognize that promotional statements by the sales force of a pharmaceutical company can evidence a drug’s intended use. Therefore, the government reasons, "[a]n approved drug that is marketed for an unapproved use…is misbranded because the labeling of such drug does not include ‘adequate directions for use.’"5
