Healthy Skepticism Library item: 15322

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Joseph JN, Deaton D, Ehsan H, Bonanno MA
Enforcement related to off-label marketing and use of drugs and devices: where have we been and where are we going?
J Health Life Sci Law 2009 Jan; 2:(2):73-108
http://www.ncbi.nlm.nih.gov/pubmed/19288889

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.