title: Evaluating promotional claims as false or misleading.
abstract: In light of the "false or misleading" standard resulting from the recent legal ruling, it can be concluded that a true claim is one that is both factually and analytically true. Factual truth could be based on the accuracy of the information and the sufficiency of the information. Analytical truth could be based on the scientific foundation for the claim and whether the information within the claim is presented in a balanced way. Regarding the assessment of whether a truthful claim is misleading, the evaluator could consider the relevance, consistency, and context of the information. Standards are important in medication use and medication regulation. Health care professionals who must decide whether a claim is truthful and not misleading will rely on guidance from FDA in determining how to evaluate promotional claims. As the court suggested in the case reviewed here, FDA could take the lead and provide guidance "in differentiating between misleading and false promotion, exaggerations and embellishments, and truthful or non-misleading information." Existing FDA regulations provide a foundation for such guidance. The next step for the agency would be to expand existing guidance to specifically describe how an off-label claim can be identified as either false or misleading.
authors.affiliation: David B. Brushwood, B.Pharm., J.D., is Professor, Department of Pharmaceutical Outcomes and Policy, College of Pharmacy; Caitlin A. Knox, M.P.H., is Ph.D. degree candidate, Department of Pharmaceutical Outcomes and Policy, College of Pharmacy; Wei Liu, M.D., M.Sc., is Ph.D. degree candidate, Department of Pharmaceutical Outcomes and Policy, College of Pharmacy; and Kevin A. Jenkins, M.A., is Ph.D. degree candidate, Department of Health Services Research, Management and Policy, College of Public Health, University of Florida, Gainesville.
authors.forename: David B
authors.initials: DB
authors.lastname: Brushwood
authors.forename: Caitlin A
authors.initials: CA
authors.lastname: Knox
authors.forename: Wei
authors.initials: W
authors.lastname: Liu
authors.forename: Kevin A
authors.initials: KA
authors.lastname: Jenkins
mesh_terms: D000329:Advertising / Q000331:legislation & jurisprudence* / Q000592:standards; D017277:Drug Approval; D004345:Drug Industry / Q000331:legislation & jurisprudence*; D004348:Drug Labeling / Q000331:legislation & jurisprudence*; D006801:Humans; D007880:Legislation, Drug; D056687:Off-Label Use / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration