Still the Great Debate – “Fair Balance” in Direct-to-Consumer Prescription Drug Advertising; Comment on “Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters”

Document Type : Commentary

Author

School of Pharmacy, Philadelphia College of Osteopathic Medicine (PCOM), Suwanee, GA, USA

Abstract

The above titled paper examined the Food and Drug Administration’s (FDA’s) warning letters and notice of violations (NOV) over a 10-year period. Findings from this content analysis reinforced what has been the primary issue for prescription direct-to-consumer advertising (DTCA) since its beginning, the fair balance of risk and benefit information. As opposed to another analysis in 2026 about this still being an issue, is there anything that can be done to prevent this problem from continuing?

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  1. Kim H. Trouble spots in online direct-to-consumer prescription drug promotion: a content analysis of FDA warning letters.  Int J Health Policy Manag. 2015;4(2):813-821. doi:10.15171/ijhpm.2015.157
  2. Food and Drug Administration (FDA). Guidance for industry: consumer directed broadcast advertisements. http://www.fda.gov/RegulatoryInformation/Guidances/ucm125039.htm. Accessed December 1, 2015. Published 1999.
  3. Food and Drug Administration (FDA). Guidance for industry: internet/social media platforms: correcting independent third-party misinformation about prescription drugs and medical devices. http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM401079.pdf. Accessed December 1, 2015.
  4. Food and Drug Administration (FDA). Draft guidance for industry: internet/social media platforms with character space limitations - presenting risk and benefit information for prescription drugs and medical devices. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM401087.pdf. Accessed December 1, 2015. Published 2014.
  5. Food and Drug Administration (FDA). Guidance for industry: fulfilling regulatory requirements for post-marketing submissions of interactive promotional media for prescription human and animal drugs and biologics. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM381352.pdf. Accessed December 1, 2015. Published 2014.
  6. Rollins BL, Perri M. Pharmaceutical Marketing. 2013. Jones & Bartlett Learning; 2013:282.
  7. Toovell B.  Prevention Magazine finds consumers believe pharmaceutical advertising in magazines and TV is fair and balanced-but less so online via 13th Annual "Consumer Reaction to DTC Advertising of Prescription Drugs.”  http://www.reuters.com/article/idUS165544+15-Jul-2010+BW20100715. Accessed December 9, 2015.
  8. Hall EJ.  The side effect of Rx advertising. Huffington Post. 2015.  http://www.huffingtonpost.com/eric-j-hall/the-side-effects-of-rx-ad_b_7030188.html.  Accessed December 9, 2015.
  9. Kessel M. Restoring the pharmaceutical industry’s reputation.  Nat Biotechnol. 2014;32(10):983-990. doi:10.1038/nbt.3036
  10. Direct-to-consumer advertising (DTCA). American Academy of Physician Assistants.  https://www.aapa.org/WorkArea/DownloadAsset.aspx?id=3099.  Accessed December 9, 2015. Published 2014. 
  11. American Medical Association (AMA).  AMA calls for ban on direct-to-consumer advertising of prescription drugs.  http://www.ama-assn.org/ama/pub/news/news/2015/2015-11-17-ban-consumer-prescription-drug-advertising.page.  Accessed December 9, 2015.
  12. Food and Drug Administration (FDA). Guidance for industry: "help-seeking" and other disease awareness communications by or on behalf of drug and device firms. http://www.fda.gov/OHRMS/DOCKETS/98fr/2004d-0042-gdl0001.pdf. Accessed February 8, 2016. Published 2004.
  13. Rollins BL, King KW, Zinkhan G, Perri M.  Drug inquiry intent and information seeking behavior: a comparison of non-branded versus branded direct-to-consumer prescription advertisements.  Drug Inf J. 2010;44(6):673-683. doi:10.1177/009286151004400603
  14. Rollins BL, King KW, Zinkhan G, Perri M.  Non-branded or branded direct-to-consumer prescription drug advertising – which is more effective?  Health Mark Q. 2011;28(1):86-98. doi:10.1080/07359683.2011.545337
  15. Bhutada NS, Rollins BL, Perri M.  Animation in direct-to-consumer advertising of prescription drugs: impact on consumers.  Health Commun. 2016; forthcoming.
  16. Rollins BL, Bhutada NS.  Impact of celebrity endorsements in disease-specific direct-to-consumer (DTC) advertisements: an elaboration likelihood model approach. International Journal of Pharmaceutical and Healthcare Marketing. 2014; 8(2):164-177.  doi:10.1108/IJPHM-05-2013-0024
  17. Bhutada NS, Rollins BL.  Disease-specific direct-to-consumer advertising of pharmaceuticals: An examination of endorser type and gender effects on consumers' attitudes and behaviors.  Res Social Adm Pharm. 2015;11(6):891-900. doi: 10.1016/j.sapharm.2015.02.003
  18. Bhutada NS, Rollins BL.  Effects of Disease-Specific Direct-to-Consumer Advertising on Medication Adherence.  J Am Pharm Assoc (2003). 2015;55:434-437.
  19. Scott D.  The untold store of TV’s first prescription ad. http://www.statnews.com/2015/12/11/untold-story-tvs-first-prescription-drug-ad/. Accessed December 11, 2015. Published 2015.