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”

Document Type : Commentary


1 Department of Anesthesiology, San Diego School of Medicine, University of California, San Diego, CA, USA

2 Department of Medicine, Division of Global Public Health, San Diego School of Medicine, University of California, San Diego, CA, USA

3 Joint Masters Program in Health Policy and Law, San Diego School of Medicine and California Western School of Law, University of California, San Diego, CA, USA

4 Global Health Policy Institute, San Diego, CA, USA


The adoption and use of digital forms of direct-to-consumer advertising (also known as “eDTCA”) is on the rise. At the same time, the universe of eDTCA is expanding, as technology on Internet-based platforms continues to evolve, from static websites, to social media, and nearly ubiquitous use of mobile devices. However, little is known about how this unique form of pharmaceutical marketing impacts consumer behavior, public health, and overall healthcare utilization. The study by Kim analyzing US Food and Drug Administration (FDA) notices of violations (NOVs) and warning letters regarding online promotional activities takes us in the right direction, but study results raise as many questions as it does answers. Chief among these are unanswered concerns about the unique regulatory challenges posed by the “disruptive” qualities of eDTCA, and whether regulators have sufficient resources and oversight powers to proactively address potential violations. Further, the globalization of eDTCA via borderless Internet-based technologies raises larger concerns about the potential global impact of this form of health marketing unique to only the United States and New Zealand. Collectively, these challenges make it unlikely that regulatory science will be able to keep apace with the continued rapid evolution of eDTCA unless more creative policy solutions are explored.


Main Subjects

  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(12):813-821. doi:10.15171/ijhpm.2015.157
  2. Mackey TK, Cuomo RE, Liang BA. The rise of digital direct-to-consumer advertising? Comparison of direct-to-consumer advertising expenditure trends from publicly available data sources and global policy implications. BMC Health Serv Res. 2015;15:236.  doi:10.1186/s12913-015-0885-1
  3. Greene JA, Kesselheim AS. Pharmaceutical marketing and the new social media. N Engl J Med. 2010;363(22):2087-2089. doi:10.1056/NEJMp1004986
  4. Davis JJ, Cross E, Crowley J. Pharmaceutical websites and the communication of risk information. J Health Commun.  2007;12(1):29-39. doi:10.1080/10810730601091326
  5. Sheehan KB. Direct-to-Consumer (DTC) Branded Drug Web Sites Risk Presentation and Implications for Public Policy. J Advert.  2013;36(3):123-135. doi:10.2753/joa0091-3367360310
  6. Liang BA, Mackey T. Direct-to-consumer advertising with interactive internet media: global regulation and public health issues. JAMA. 2011;305(8):824-825. doi:10.1001/jama.2011.203
  7. Tyrawski J, DeAndrea DC. Pharmaceutical Companies and Their Drugs on Social Media: A Content Analysis of Drug Information on Popular Social Media Sites. J Med Internet Res. 2015;17(6):e130.
  8. Global Medicines Use in 2020:  Outlook and Implications. IMS Institute for Health Informatics website. Published November 2015.
  9. Mackey TK, Liang B. Globalization, Evolution and emergence of direct-to-consumer advertising: are emerging markets the next pharmaceutical marketing frontier. J Commer Biotechnol. 2012;18:58-64. doi:10.5912/jcb564
  10. Medicines Use and Spending Shifts: A Review of the Use of Medicines in the U.S. in 2014. IMS Institute for Health Informatics website. Published April.
  11. Greene JA, Watkins ES. The vernacular of risk--rethinking direct-to-consumer advertising of pharmaceuticals. N Engl J Med. 2015;373(12):1087-1089.
  12. Liang BA, Mackey T. Reforming direct-to-consumer advertising. Nat Biotechnol. 2011;29(5):397-400. doi:10.1038/nbt.1865
  13. Mackey TK, Liang BA. It's time to shine the light on direct-to-consumer advertising. The Annals of Family Medicine. American Academy of Family Physicians. 2015;13(1):82-85. doi:10.1370/afm.1711
  14. Health Fact Sheet. Pew Internet website. Accessed April 29, 2014. Published 2014.
  15. Gibson S. Regulating Direct-to-Consumer Advertising of Prescription Drugs in the Digital Age. Laws. 2014;3(3):410-438. doi:10.3390/laws3030410
  16. 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.
  17. Ambekar H, Sharma A, Prathipati A. How technology is going to disrupt health care. Forbes. 2014. Accessed  December 13, 2015.
  18. Guidance for industry: internet/social media platforms: correcting independent third-party misinformation about prescription drugs and medical devices. FDA Website. Accessed  December 14, 2015. Published 2014.
  19. Guidance for industry: internet/social media platforms with character space limitations— presenting risk and benefit information for prescription drugs and medical devices. FDA website. Accessed  December 14, 2015. Published 2014.
  20. Guidance for industry: product name placement, size, and prominence in advertising and promotional labeling. FDA website. Accessed  December 14, 2015. Published 2013.
  21. Guidance for industry: responding to unsolicited requests for off-label information about prescription drugs and medical devices. FDA website. Accessed  December 14, 2015. Published 2011.
  22. Nguyen D, Seoane-Vazquez E, Rodriguez-Monguio R, Montagne M. Changes in FDA enforcement activities following changes in federal administration: the case of regulatory letters released to pharmaceutical companies. BMC Health Serv Res. 2013;13:27. doi:10.1186/1472-6963-13-27
  23. Ventola CL. Direct-to-consumer pharmaceutical advertising: therapeutic or toxic? P T. 2011;36(10):669-684.
  24. Tatsioni A, Gerasi E, Charitidou E, Simou N, Mavreas V, Ioannidis JPA. important drug safety information on the internet: assessing its accuracy and reliability. Drug Saf. 2003;26(7):519. doi:10.2165/00002018-200326070-00005
  25. Neumann PJ, Bliss SK. FDA actions against health economic promotions, 2002–2011. Value Health. 2012;15(6):948-953. doi:10.1016/j.jval.2012.05.002
  26. Collier R. Patient engagement or social media marketing? CMAJ. 2014;186(8):E237-E238. doi:10.1503/cmaj.109-4739
  27. Liang BA, Mackey T. Health care policy. Reforming off-label promotion to enhance orphan disease treatment. Science. 2010;327(5963):273-274. doi:10.1126/science.1181567
  28. Wittich CM, Burkle CM, Lanier WL. Ten common questions (and their answers) about off-label drug use. Mayo Clin Proc. 2012;87(10):982-990. doi:10.1016/j.mayocp.2012.04.017
  29. Mackey T, Liang B. Off label promotion reform: a legislative proposal addressing vulnerable patient drug access and limiting inappropriate pharmaceutical marketing. University of Michigan Journal of Law Reform. 2011;45(1).
  30. Hamel MB, Avorn J, Sarpatwari A, Kesselheim AS. Forbidden and permitted statements about medications — loosening the rules. N Engl J Med. 2015;373(10):967-973. doi:10.1056/nejmhle1506365
  31. Complaint, Amarin Pharma, Inc. v. U.S. Food and Drug Administration (S.D.N.Y. 2015).
  32. Sharfstein JM, Charo A. The promotion of medical products in the 21st century: off-label marketing and first amendment concerns. JAMA. 2015;314(17):1795-1796. doi:10.1001/jama.2015.12045
  33. Boumil MM. Off-Label Marketing and the First Amendment. N Engl J Med. 2013;368(2):103-105.
  34. Andreassen HK, Bujnowska-Fedak MM, Chronaki CE, et al. European citizens' use of E-health services: a study of seven countries. BMC Public Health. 2007;7:53. doi:10.1186/1471-2458-7-53
  35. Mintzes B. Direct to consumer advertising of prescription drugs. BMJ. 2008;337:a985. doi:10.1136/bmj.a985
  36. Mintzes B. Should Canada allow direct-to-consumer advertising of prescription drugs? no. Can Fam Physician. 2009;55(2):131-133.
  37. Mintzes B, Barer ML, Kravitz RL, et al. Influence of direct to consumer pharmaceutical advertising and patients' requests on prescribing decisions: two site cross sectional survey. BMJ. 2002;324(7332):278-279. doi:10.1136/bmj.324.7332.278
  38. Fayerman P. B.C. Medical Association wants crackdown on online drug advertising. The Vancouver Sun website. Accessed  December 23, 2013. Published February 27, 2013.
  39. AMA Calls for Ban on Direct to Consumer Advertising of Prescription Drugs and Medical Devices. American Medical Association website. Accessed  December 12, 2015. Published 2015.
  40. Robertson CT. New DTCA guidance — enough to empower consumers? N Engl J Med. 2015;373(12):1085-1087. doi:10.1056/nejmp1508548