Healthy Skepticism Library item: 7552

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

Kahan JS, Shapiro JK.
The First Amendment and the Food and Drug Administration's regulation of labeling and advertising: three proposed reforms.
Food Drug Law J 2003; 58:(3):353-64

Abstract:

This article focuses on 3 areas, regarding the reguation of drug product labeling and advertising, that are believed to require reform. The Food and Drug Administration’s (FDA) restrictions on the dissemination of peer-reviewed journal articles and reference texts (collectively “enduring materials”) that discuss unapproved (off-label) uses for medical products are discussed. FDA’s restrictions on the dissemination of information about clinical experience with investigational medical devices prior to premarket clearance or approval and FDA’s restrictions on the dissemination of information about postapproval clinical experience with medical devices are considered.

Keywords:
Advertising/legislation & jurisprudence* Commerce/legislation & jurisprudence Device Approval/legislation & jurisprudence Freedom Product Labeling/legislation & jurisprudence* Speech United States United States Food and Drug Administration/legislation & jurisprudence*