Healthy Skepticism Library item: 7550

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

Evans GW, Friede AI
The Food and Drug Administration's regulation of prescription drug manufacturer speech: a First Amendment analysis.
Food Drug Law J. 2003; 58:(3):365-437

Abstract:

This report focuses on the need for the Food and Drug Administration (FDA) to reform regulations which breech the First Amendment and how it should adjust its regulatory approach regarding restraints placed on manufacturer speech. The authors suggest that the agency should continue to closely regulate operative labeling, which has an indispensable role in ensuring safe and effective drug use. With respect to promotional communications, however, FDA should take a targeted approach that focuses on demonstrably false or misleading materials-and thereby support the contributions of truthful and nonmisleading communications in alerting consumers and physicians to potentially valuable new treatments.

Keywords:
Advertising/legislation & jurisprudence Consumer Participation/legislation & jurisprudence Drug Approval Drug Industry/legislation & jurisprudence* Humans Information Services Prescriptions, Drug Product Labeling/legislation & jurisprudence Speech United States United States Food and Drug Administration/legislation & jurisprudence*