Healthy Skepticism Library item: 7555

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

Gibbs JN, Ferrari PL, Murphy AM;
Ripe for revision: Reassessing the constitutionality of Food and Drug Administration restrictions on protected speech
Food and Drug Law Journal 2003; 58:(3):331-345

Abstract:

This article highlights 2 of the Food and Drug Administration’s (FDA) regulatory provisions that are being reassessed for possible revision. The first is the requirement that an applicant submitting a new drug application (NDA), subject to FDA’s accelerated approval regulation, must submit copies of all promotional materials for the agency’s review before the materials are disseminated. The second is FDA’s policies regarding the dissemination of information related to the use of approved products for unapproved uses (“off-label uses”).

Keywords:
Advertising/legislation & jurisprudence Commerce/legislation & jurisprudence Humans Information Services/legislation & jurisprudence Marketing of Health Services/legislation & jurisprudence* Product Labeling/legislation & jurisprudence Speech* United States United States Food and Drug Administration/legislation & jurisprudence*