Healthy Skepticism Library item: 6782

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

Baylor-Henry M, Drezin NA.
Regulation of prescription drug promotion: direct-to-consumer advertising.
Clin Ther 1998; 20:

Abstract:

The US Food and Drug Administration (FDA) is responsible for regulating the information on prescription drugs disseminated by sponsors to health care providers and consumers to ensure that it is truthful and not misleading, and that it presents a fair balance of benefit and risk information. Thus the public health is both protected and promoted by the dissemination of honest, accurate information about regulated products. This paper discusses the regulatory requirements for promotional materials for prescription drugs and the standards used by the FDA to evaluate these materials. It also discusses the agency’s views on direct-to-consumer advertising, the enforcement actions that are available to the FDA, the process used by the FDA to determine what action should be taken and when, and what remedies are available.

Keywords:
Advertising/legislation & jurisprudence* Advertising/standards Drug Industry/legislation & jurisprudence* Drug Industry/standards Drug Labeling Humans Pharmaceutical Preparations/standards* Prescriptions, Drug/standards United States United States Federal Trade Commission United States Food and Drug Administration