Healthy Skepticism Library item: 1932

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

Stewart KA, Neumann PJ.
FDA actions against misleading or unsubstantiated economic and quality-of-life promotional claims: an analysis of warning letters and notices of violation.
Value Health 2002 Sep-Oct; 5:(5):389-96
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12201856

Abstract:

OBJECTIVES: The objective of this study was to understand the types of economic and quality-of-life promotional claims the FDA considers false or misleading.

METHODS: Publicly available FDA letters (n = 569) sent to pharmaceutical companies from 1997 through 2001 for inappropriate promotional claims were reviewed. A standard data collection form was developed, including six categories for economic violations and three for QOL violations. For QOL, only letters with explicit violations for false or misleading claims using the words “quality of life” or patient “well-being” were considered. Other information collected included type of regulatory letter and media in which violations were found.

RESULTS: Twenty-eight (4.9%) letters cited false and/or misleading economic claims. The most common economic violation was “unsupported comparative claim of effectiveness, safety, or interchangeability” (n = 14). Twenty-eight (4.9%) letters cited QOL violations, of which four contained both economic and QOL violations. The most common QOL violation was “lack of substantial evidence for QOL claims” (n = 15). None of the FDA letters used the term “patient reported outcomes.” Violations were found most frequently in brochure and Web site-based promotions.

CONCLUSIONS: The body of evidence that is emerging illustrates how the FDA is regulating promotional material containing misleading or unsubstantiated economic and QOL claims. However, knowing what constitutes an appropriate claim remains challenging because there are no formal guidelines describing what constitutes a violation, nor what level of substantiating evidence is required. More guidance may be needed to ensure appropriate use of these claims in drug promotions.

Keywords:
Advertising/legislation & jurisprudence Advertising/standards* Drug Industry/legislation & jurisprudence Drug Industry/standards* Economics, Pharmaceutical Fraud* Humans Quality of Life Research Support, Non-U.S. Gov't Treatment Outcome United States United States Food and Drug Administration* analytic survey United States journal advertisements FDA Food and Drug Administration FDA quality of information quality of life claims EVALUATION OF PROMOTION: PROMOTIONAL BROCHURES EVALUATION OF PROMOTION: JOURNAL ADVERTISEMENTS PROMOTIONAL TECHNIQUES: INTERNET ADVERTISING REGULATION, CODES, GUIDELINES: COMPLIANCE, SANCTIONS, STANDARDS REGULATION, CODES, GUIDELINES: DIRECT GOVERNMENT REGULATION