Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters

Document Type: Original Article

Author

School of Media and Journalism, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA

Abstract

Background
For the purpose of understanding the Food and Drug Administration’s (FDA’s) concerns regarding online promotion of prescription drugs advertised directly to consumers, this study examines notices of violations (NOVs) and warning letters issued by the FDA to pharmaceutical manufacturers.
 
Methods
The FDA’s warning letters and NOVs, which were issued to pharmaceutical companies over a 10-year period (2005 to 2014) regarding online promotional activities, were content-analyzed.
 
Results
Six violation categories were identified: risk information, efficacy information, indication information, product labeling, material information issues, and approval issues. The results reveal that approximately 95% of the alleged violations were found on branded drug websites, in online paid advertisements, and in online videos. Of the total 179 violations, the majority of the alleged violations were concerned with the lack of risk information and/or misrepresentation of efficacy information, suggesting that achieving a fair balance of benefit versus risk information is a major problem with regard to the direct-to-consumer advertising (DTCA) of prescription drugs. In addition, the character space limitations of online platforms, eg, sponsored links on search engines, pose challenges for pharmaceutical marketers with regard to adequately communicating important drug information, such as indication information, risk information, and product labeling.
 
Conclusion
Presenting drug information in a fair and balanced manner remains a major problem. Industry guidance should consider addressing visibility and accessibility of information in the web environment to help pharmaceutical marketers meet the requirements for direct-to-consumer promotion and to protect consumers from misleading drug information. Promotion via social media warrants further attention, as pharmaceutical manufacturers have already begun actively establishing a social media presence, and the FDA has thus begun to keep tabs on social media promotions of prescription drugs.

Highlights

Commentaries Published on this Paper

  • The Conundrum of Online Prescription Drug Promotion; Comment on “Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters”

          Abstract | PDF

  • 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”

          Abstract | PDF

  • The Tip of the Iceberg of Misleading Online Advertising; Comment on “Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters”

          Abstract | PDF

  • Digital Direct-to-Consumer Advertising: A Perfect Storm of Rapid Evolution and Stagnant Regulation; Comment on “Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters”

          Abstract | PDF

  • Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: Teaching Drug Marketers How to Inform Better or Spin Better?; Comment on “Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters”

          Abstract | PDF

  • Future Challenges and Opportunities in Online Prescription Drug Promotion Research; Comment on “Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters”

          Abstract | PDF

  • Considering the Future of Pharmaceutical Promotions in Social Media; Comment on “Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters”

          Abstract | PDF

 

Author’s Response to the Commentaries

  • Looking Beyond FDA Warning Letters to Explore Unforeseen Trouble Spots in eDTCA: A Response to Recent Commentaries

          Abstract | PDF

Keywords

Main Subjects


"Watch the Video Summary"

  1. Campbell S. Promotional Spending for Prescription Drugs. https://www.cbo.gov/sites/default/files/111th-congress-2009-2010/reports/12-02-drugpromo_brief.pdf. Accessed April 16, 2015. Published December 2, 2009.
  2. Palumbo FB, Mullins CD. The development of direct-to-consumer prescription drug advertising regulation. Food Drug Law J. 2002;57(3):423-443.
  3. Calfee J. Public policy issues in direct-to-consumer advertising of prescription drugs. J Public Policy Mark. 2002;21(2):174-193.
  4. Campbell S. Potential Effects of a Ban on Direct-to-Consumer Advertising of New Prescription Drugs. https://www.cbo.gov/sites/default/files/112th-congress-2011-2012/reports/5-25-prescriptiondrugadvertising.pdf. Published May 2011.
  5. Dobrow L. DTC Report: DTC Gets Smart - Medical Marketing and Media. Med Mark Media. http://www.mmm-online.com/features/dtc-report-dtc-gets-smart/article/339357/. Accessed August 22, 2015. Published 2014.
  6. Lorence D, Churchill R. A study of the web as DTC drug marketing agent. J Med Syst. 2007;31(6):551-556. doi:10.1007/s10916-007-9098-4
  7. Liang BA, Mackey TK. Prevalence and global health implications of social media in direct-to-consumer drug advertising. J Med Internet Res. 2011;13(3):e64.
  8. Thomaselli R. Web thrives as DTC platform.  http://adage.com/article/digital/web-thrives-dtc-platform/96790/. Accessed April 16, 2015. Published November 10, 2003.
  9. Food and Drug Administration (FDA). Prescription Drug Advertising - Background on Drug Advertising. http://www.fda.gov/Drugs/ResourcesForYou/Consumers/PrescriptionDrugAdvertising/ucm071964.htm. Accessed April 16, 2015.
  10. Food and Drug Administration (FDA). Prescription Drug Advertising - Prescription Drug Advertising: Questions and Answers. http://www.fda.gov/Drugs/ResourcesForYou/Consumers/PrescriptionDrugAdvertising/UCM076768.htm. Accessed April 16, 2015.
  11. Food and Drug Administration (FDA). Guidance for Industry: Consumer Directed Broadcast Advertisements. http://www.fda.gov/RegulatoryInformation/Guidances/ucm125039.htm. Accessed April 16, 2015. Published 1999.
  12. Food and Drug Administration (FDA). Prescription Drug Advertising - Drug Advertising: A Glossary of Terms. http://www.fda.gov/Drugs/ResourcesForYou/Consumers/PrescriptionDrugAdvertising/ucm072025.htm. Accessed April 16, 2015.
  13. Aikin KJ, Swasy JL, Braman A. Patient and Physician Attitudes and Behaviors Associated With DTC Promotion of Prescription Drugs — Summary of FDA Survey Research Results. http://www.fda.gov/Drugs/ScienceResearch/ResearchAreas/DrugMarketingAdvertisingandCommunicationsResearch/ucm151498.htm. Published May 19, 2004.
  14. 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 April 16, 2015.
  15. Food and Drug Administration (FDA). Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070076.pdf. Accessed April 27, 2015. Published 2013.
  16. 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 April 27, 2015. Published 2014.
  17. Food and Drug Administration (FDA). Guidance for Industry: Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM381352.pdf. Accessed April 16, 2015. Published 2014.
  18. Schwartz V, Silverman C, Hulka M, Appel C. Marketing pharmaceutical products in the twenty-first century: an analysis of the continued viability of traditional principles of law in the age of direct-to-consumer advertising. Harv J Law Public Policy. 2009;32:333-354.
  19. Bell R, Kravitz R, Wilkes M. Direct-to-consumer prescription drug advertising and the public. J Gen Intern Med. 1999;14(11):651-657.
  20. Sheehan K. Balancing acts: an analysis of Food and Drug Administration letters about direct-to-consumer advertising violations. J Public Policy Mark. 2003;22(2):159-169.
  21. Vogt DU. CRS Report for Congress: Direct-to-Consumer Advertising of Prescription Drugs. Congressional Research Service; 2005.
  22. Welch Cline RJ, Young HN. Marketing drugs, marketing health care relationships: a content analysis of visual cues in direct-to-consumer prescription drug advertising. Health Commun. 2004;16(2):131-157.
  23. Lurie P. DTC advertising harms patients and should be tightly regulated. J Law Med Ethics. 2009;37(3):444-450. doi:10.1111/j.1748-720X.2009.00405.x
  24. Gibson S. Regulating direct-to-consumer advertising of prescription drugs in the digital age. Laws. 2014;3(3):410-438.
  25. Sheehan K. Direct-to-consumer (DTC) branded drug web sites risk presentation and implications for public policy. J Advert. 2007;36(3):123-135. doi: 10.2753/JOA0091-3367360310
  26. Huh J, Cude B. Is the information “fair and balanced” in direct-to-consumer prescription drug websites? J Health Commun. 2004;9(6):529-540.
  27. Miley M. Big Pharma Taking Steps to Reach Patients With Digital Media.  http://adage.com/article/news/big-pharma-taking-steps-reach-patients-digital-media/136538/. Accessed April 16, 2015.
  28. Hayes A, Krippendorff K. Answering the call for a standard reliability measure for coding data. Commun Methods Meas. 2007;1(1):77-89.
  29. Food and Drug Administration (FDA). Letter to Novartis Pharmaceuticals. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM221325.pdf. Accessed July 15, 2015. Published 2010.
  30. Food and Drug Administration (FDA). Letter to Institut Biochimique SA. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM388800.pdf. Accessed July 15, 2015. Published 2014.
  31. Food and Drug Administration (FDA). Letter to BioMarin Pharmaceutical. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm053647.pdf. Accessed April 28, 2015. Published 2006.
  32. Food and Drug Administration (FDA). Letter to Astellas Pharma. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM208795.pdf. Accessed April 28, 2015. Published 2010.
  33. Liang BA, Mackey T. Direct-to-consumer advertising with interactive internet media: global regulation and public health issues. J Am Med Assoc. 2011;305(8):824-825. doi:10.1001/jama.2011.203
  34. Kreuter M, Bull F, Clark E, Oswald D. Understanding how people process health information: a comparison of tailored and nontailored weight-loss materials. Heal Psychol. 1999;18(5):487-494.
  35. Bettman J, Kakkar P. Effects of information presentation format on consumer information acquisition strategies. J Consum Res. 1977;3(4):233-240.
  36. Yoo CY, Kim K, Stout PA. Assessing the effects of animation in online banner advertising: hierarchy of effects model. J Interact Advert. 2004;4(2):49-60.
  37. Sewak S, Wilkin N, Bentley J, Smith M. Direct-to-consumer advertising via the Internet: The role of Web site design. Res  Social Adm Pharm. 2005;1(2):289-309. doi:10.1016/j.sapharm.2005.03.012