title: Consumers' Understanding of FDA Approval Requirements and Composite Scores in Direct-to-Consumer Prescription Drug Print Ads.
abstract: In 2 studies, we investigated how laypersons perceive the Food and Drug Administration (FDA) approval process, FDA authority, and the presentation of composite scores in direct-to-consumer (DTC) prescription drug print ads. The 1st study consisted of 4 focus groups (N = 38) in 2 cities. Using a semi-structured guide, a moderator led participants through the viewing of 3 existing DTC print ads that differed in the presence or absence of composite score information, and participants discussed their views of the ads and their understanding of composite scores. The 2nd study surveyed a nationally representative sample of 1,629 individuals from the general population who saw a fictitious DTC print ad and answered closed-ended questions about the same topics. Results showed that knowledge of FDA approval and authority was mixed, with several misconceptions apparent. Many consumers were not familiar with the use of composite scores in a medical context or in advertising and, in the 1st study, expressed distrust of the product and the ad after learning about how composite scores are used. In the 2nd study, receiving composite score information changed the perceived clarity of the ad but not the perceived risk or benefits. Implications for the presentation of complex medical information are discussed.
authors.affiliation: a U.S. Food and Drug Administration , Silver Spring , Maryland , USA.
authors.forename: Amie C
authors.initials: AC
authors.lastname: O'Donoghue
authors.affiliation: a U.S. Food and Drug Administration , Silver Spring , Maryland , USA.
authors.forename: Helen W
authors.initials: HW
authors.lastname: Sullivan
authors.affiliation: b RTI International, Inc. , Research Triangle Park , North Carolina , USA.
authors.forename: Pamela A
authors.initials: PA
authors.lastname: Williams
authors.affiliation: b RTI International, Inc. , Research Triangle Park , North Carolina , USA.
authors.forename: Claudia
authors.initials: C
authors.lastname: Squire
authors.affiliation: a U.S. Food and Drug Administration , Silver Spring , Maryland , USA.
authors.forename: Kevin R
authors.initials: KR
authors.lastname: Betts
authors.affiliation: b RTI International, Inc. , Research Triangle Park , North Carolina , USA.
authors.forename: Jessica
authors.initials: J
authors.lastname: Fitts Willoughby
authors.affiliation: b RTI International, Inc. , Research Triangle Park , North Carolina , USA.
authors.forename: Sarah
authors.initials: S
authors.lastname: Parvanta
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000067088:Direct-to-Consumer Advertising / Q000379:methods*; D017277:Drug Approval; D005260:Female; D017144:Focus Groups; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D008297:Male; D008875:Middle Aged; D055553:Prescription Drugs / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration; D055815:Young Adult
chemical_list: D055553:Prescription Drugs