Healthy Skepticism Library item: 7549

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

Blackwell AE, Beck JM
Drug manufacturers' First Amendment right to advertise and promote their products for off-label use: Avoiding a pyrrhic victory
Food and Drug Law Journal 2003; 58:(3):439-462

Abstract:

Current Food and Drug Administration (FDA) regulation and enforcement policies prohibit drug and medical device manufacturers from promoting off-label uses for their approved products, except in narrowly defined circumstances. Future invalidation of FDA’s current regime, restricting manufacturer speech promoting off-label use, may lead to the adoption of alternative nonspeech-restrictive policies designed to further the agency’s regulatory interests. It is believed by the authors that drug manufacturers are likely to consider some of these alternative policies even less desirable than the speech-restrictive policies currently in place. Hence, it is recommended that regulated manufacturers should take seriously the task of identifying, and suggesting to FDA, desirable new policies designed to advance the agency’s important interests. Regulated manufacturers also should consider the most effective strategies for encouraging FDA to adopt one of these more desirable policy alternatives.

Keywords:
Advertising/legislation & jurisprudence* Cost-Benefit Analysis Drug Approval Drug Industry/legislation & jurisprudence* Freedom Humans Prescriptions, Drug Product Labeling/legislation & jurisprudence* Speech United States United States Food and Drug Administration/legislation & jurisprudence*