History and Characteristics of Direct-to-Consumer Advertising in the United States

Marta Makowska


Direct-to-consumer advertising (DTCA) in which pharmaceutical companies market prescription drugs directly to consumers is legal in only two countries – the USA and New Zealand. This article describes legislative milestones of DTCA development in the USA which have given rise to the current legal framework.

The article shows the cultural background for DTCA expansion, outlining the fight of patients’ associationsfor better access to information about therapy and drugs and change in perceiving the role of the patient in the health care professional-patient relations. It presents arguments supporting the producers’ right to advertise their products.

Direct-to-consumer advertising in the USA is a controversial subject. Although based on only limited data, the existing research gives arguments both in favour and against direct-to-customer advertising. The article also presents the EU policy towards DTCA, considering the consequences of the existing DTCA ban in the EU.

Słowa kluczowe: reklama leków, leki na receptę, pacjenci, marketing farmaceutyczny

Mogull S., Chronology of direct-to-consumer advertising regulation in the United States, “American Medical Writers Association Journal” 2008; 23 (3): 106–109.

Abel G.A., Penson R.T., Joffe S., Schapira L., Chabner B.A., Lynch T.J., Jr., Direct-to-consumer advertising in oncology, “Oncologist” 2006; 11: 217–226.

Donohue J., history of drug advertising: the evolving roles of consumers and consumer protection, “The Milbank Quarterly” 2006; 84 (4): 659–699.

Parekh A., Marcus R., Roberts M., Raisch D.W., Risks and Benefits of Direct to Consumer Advertising on Patient-Provider Relationships, International Society for Pharmacoeconomics and Outcomes Research, https://www.ispor.org/sigs/risk benefitmanagement/DTCAarticle23Nov2011.pdf; accessed: 16.07.2013.

Ventola C.L., Direct-to-consumer pharmaceutical advertising. Therapeutic or toxic?, “Pharmacy and Therapeutics” 2011; 36 (10): 669–674, 681–684.

European Federation of Pharmaceutical Industries and Associations, The Pharmaceutical Industry in Figures, Belgium 2012.

Shorter E., Doctors and Their Patients. Social History, Transaction Publishers, New Jersey 1991.

Lyles A., Direct marketing of pharmaceuticals to consumers, “Annual Review of Public Health” 2002; 23: 73–91.

Boden W.E., Diamond G.A., DTCA for PTCA – crossing the line in consumer health education?, “New England Journal of Medicine” 2008: 2197, http://www.nejm.org/doi/pdf/10.1056/NEJMp0801433; accessed: 19.07.2013.

Kravitz R.L., Direct-to-consumer advertising of prescription drugs, “The Western Journal of Medicine” 2000; 173 (4): 221.

Pharma News, http://www.news.pharma-mkting.com/pmn114-article03.htm; accessed: 19.07.2013.

Food and Drug Administration, Guidance Compliance Re­gulatory Information, http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm064956.htm; accessed: 19.07.2013.

Epstein Becker & Green, P.C., USA, in: Global Legal Group (eds), The International Comparative Legal Guide to: Pharmaceutical Advertising 2011. practical cross-border insight into pharmaceutical advertising, London 2011: 316–331.

Food and Drug Administration, Prescription Drug Advertising, http://www.fda.gov/Drugs/ResourcesForYou/Consumers/PrescriptionDrugAdvertising/ucm083573.htm; accessed: 19.07.2013.

Ta S., Frosch D., Pharmaceutical product placement: simply script or prescription for trouble?, “Journal of Public Policy & Marketing” 2008; 27: 98–106.

Donohue M., Pharmaceutical product placements: the next DTC?, “Pharmaceutical Executive” 2008; 28 (10): G8.

Aikin K.J., Swasy J.L., Braman A.C., Patient and Physician Attitudes and Behaviors Associated with DTC Promotion of Prescription Drugs – Summary of FDA Survey Research Results, Department of Health and Human Services. Food and Drug Administration, Center for Drug Evaluation and Research, Washington, D.C 2004: 19.

Parnes B., Smith P.C., Gilroy C., Quintela J., Emsermann C.B., Dickinson L.M., Westfall J.M., Lack of impact of direct-to-consumer advertising on the physician-patient encounter in primary care: SNOCAP report, “Annals of Family Medicine” 2009; 7: 41–46.

Viale P.H., What nurse practitioners should know about direct-to-consumer advertising of prescription medications, “Journal of the American Academy of Nurse Practitioners” 2003; 15: 297–304.

Frosch L.D., Krueger P.M., Hornik R.C., Cronholm P.F., Barg F.K., Creating demand for prescription drugs: content analysis of television direct-to-consumer advertising, “Annals of Family Medicine” 2007; 5 (1): 6–13.

Shaw A., Direct-to-consumer advertising of pharmaceuticals: the DTC advertising debate, ProQuest 2008, www.csa.com/discoveryguides/direct/review4.php; accessed: 19.07.2013.

Stange K.C., Time to ban direct-to-consumer prescription drug marketing, “Annals of Family Medicine” 2007; 5 (2): 101–104.

Directive of the European Parliament 2001/83 / EC Art. 88 paragraph 1.

Arnold D., Oakley J., The politics and strategy of industry self-regulation: the pharmaceutical industry’s principles for ethical direct-to-consumer advertising as deceptive blocking strategy, “Journal of Health Politics, Policy and Law” 2013; 3: 505–544.

Makowska M., Lekarze firmy farmaceutyczne – standardy etyczne wzajemnych relacji Unii Europejskiej, “Annales. Etyka życiu gospodarczym” 2012; 15: 143–154.

Journal of Laws 1991, no. 105, item 452.

Journal of Laws 1993, no. 47, item 211.

Federacja Konsumentów, Reklama leków, paraleków preparatów witaminowych, http://www.federacja-konsumentow.org.pl/story.php?story=133; accessed: 22.07.2013.

Journal of Laws 2008, no. 45, item 271, art. 57, paragraph 1.

Czasopismo ukazuje się w sposób ciągły on-line.
Pierwotną wersją czasopisma jest wersja elektroniczna.