title: Enforcement related to off-label marketing and use of drugs and devices: where have we been and where are we going?
abstract: Off-label drug or medical device "use" is the practice of prescribing drugs or medical devices to patients for a purpose not included on the federally approved label. Off-label "marketing" is the practice of attempting to influence physicians to prescribe drugs or devices for off-label purposes. The federal Food and Drug Administration (FDA) maintains regulatory authority over the proper labeling of drugs and medical devices. Although not illegal, off-label use of certain drugs has led to controversy in recent years, especially in light of alleged behind-the-scenes marketing practices intended to increase off-label prescribing. Off-label marketing practices are prohibited and could result in criminal charges against a manufacturer, depending upon the circumstances. Yet a vast gray area exists for subtle marketing practices, such as circulating published medical studies about off-label uses to physicians. This article summarizes the legal and medical standards associated with off-label use and marketing of drugs, provides summaries of recent enforcement activities regarding off-label marketing, and explains the current federal regulatory issues surrounding off-label marketing practices. The authors provide practical pointers on regulatory compliance and the risks associated with fraud and abuse laws for drug companies and practitioners.
authors.affiliation: Civil Division, U.S. Attorney's Office, Eastern District of Pennsylvania, USA. jjoseph@postschell.com
authors.forename: John N
authors.initials: JN
authors.lastname: Joseph
authors.forename: David
authors.initials: D
authors.lastname: Deaton
authors.forename: Houman
authors.initials: H
authors.lastname: Ehsan
authors.forename: Mark A
authors.initials: MA
authors.lastname: Bonanno
mesh_terms: D000329:Advertising / Q000331:legislation & jurisprudence*; D004348:Drug Labeling / Q000331:legislation & jurisprudence*; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration