Fair Balance in Direct-to-Consumer Antidepressant Print and Television Advertising, 1995–2007

Abstract

The authors evaluated fair balance in the presentation of risks and benefits in a large sample of direct-to-consumer advertising for prescription antidepressant medications appearing in magazines (1995–2006) and television (1999–2007) to assess how well they meet U.S. Food and Drug Administration guidelines. Using content analysis to capture relevant dimensions of the ads, results indicated that (a) considerably less attention is given to risks relative to benefits and (b) implicit ad content favors communication of drug benefits over risks, but that fair balance in direct-to-consumer ads has improved over time. The authors discuss policy implications and explore future research directions.

Acknowledgments

Support for the data collected as part of this study was funded by a philanthropic grant provided by the Merck Company Foundation.

Notes

¹Prescription drug ads are not required to be preapproved by the FDA (Huh, Delorme, Reid, & An, 2010). Preapproval is required only when the drug has been approved for use by the FDA on an accelerated basis. However, many companies ask for preapproval from the FDA (specifically the Division of Drug Marketing, Advertising, and Communications). This way, the manufacturer can avoid post hoc corrective judgment by the FDA (Ostrove, 2001).

²Until the FDA issued guidelines in 1997 with these details regarding “adequate provision,” little promotion took place through broadcast media (FDA, 2004; Department of Health and Human Services, Draft Guidance for Industry: Broadcast Advertising of Prescription Drugs).

³A “unique ad” is defined as a creative ad that is unique in its design and content and differs in substantive ways from other ads promoting the same brand.

⁴For a more detailed description of the National Consumer Survey, the methods used in the selection of magazines included in the digital advertising database, and the digital archive itself, see Avery and colleagues (2007).

⁵It is possible but unlikely that other unique advertisements for antidepressants appear in the magazines not covered in our database, but it is estimated that the database accounts for approximately 57.7% of all magazine readership in the United States (Avery et al., 2007).

⁶Precise operational definitions of study measures, the coding instrument, code book, and training materials are available from the authors upon request.

⁷Reliability results for all variables in the study are available from the authors upon request.

^a Other actions include Food and Drug Administration (FDA) approval of product/brand extensions or approval of same drug for other indications.

^a Examples: stroke, raised blood pressure, suicidal thoughts, changes in mood/behavior, seizures, eating disorders.

^b Examples of statements: “Few people experienced side effects,” “As with any drug, X drug has certain side effects,” “Some people experienced side effects,” “Most side effects were mild or moderate,” and “Side effects did not stop people from taking the medication.”