Healthy Skepticism Library item: 7557

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

Waxman HA.
A history of adverse drug experiences: Congress had ample evidence to support restrictions on the promotion of prescription drugs.
Food Drug Law J 2003; 58:(3):299-312

Abstract:

This paper discusses a notice issued by the Food and Drug Administration (FDA) that there may be a case for ceasing to enforce many of the promotional/marketing restrictions of the Food, Drug, and Cosmetic Act (FDCA). The FDA currently believe, under the First Amendment, pharmaceutical companies should be trusted to provide products to the public that live up to their promotional claims. The author provides the history of FDCA and incidents of public harm, misleading advertising by manufacturers, and debates the justification for the FDA’s issued notice.

Keywords:
Adverse Drug Reaction Reporting Systems Advertising*/legislation & jurisprudence Drug Industry*/legislation & jurisprudence Humans Patient Participation Pharmaceutical Preparations/adverse effects United States United States Food and Drug Administration