FDA Seeks Comments on Clinical Benefit Information in Professional Labeling, Direct-to-Consumer Print Advertisements
This post was written by Paul Sheives.
FDA has announced plans to conduct a study entitled “Clinical Benefit Information in Professional Labeling and Direct-to-Consumer Print Advertisements for Prescription Drugs.” The purpose of the study is to: (1) understand how physicians processclinical efficacy information and how they interpret approved product labelinformation; (2) determine physicianpreferences for alternative presentationsof clinical efficacy information in direct-to-consumer (DTC)advertising, and (3) examine howdifferent presentations of clinicalefficacy information in DTC advertisingaffect consumers’ perceptions of efficacyand safety. The study is focused on how physicians andconsumers make risk/benefitassessments in response to variations in presentation of the efficacy information on the first page of the document. FDA is accepting written comments until January 3, 2011.
