Direct-to-consumer advertising (DTC advertising) usually refers to the marketing of pharmaceutical products but can apply in other areas as well. This form of advertising is directed toward patients, rather than healthcare professionals. The Food and Drug Administration is responsible for regulating DTC advertising in the United States. The FDA’s latest version of guidelines, though still in draft form, for pharmaceutical drug advertising was updated in 2009. Forms of DTC advertising include TV, print, radio and other mass and social media. There are ethical and regulatory concerns regarding DTC advertising, specifically the extent to which these ads may unduly influence the prescribing of the prescription medicines based on consumer demands when, in some cases, they may not be medically necessary.
Nations permitting DTC
To date only two nations permit DTC (Nation, year of legalization)
Pharmaceutical industry controversy
All Western nations, with the exception of New Zealand and the United States, have historically (since the 1940s for Australasia, North America, and Europe) banned direct advertising of pharmaceuticals to consumers.
Under pressure from doctors and the American Medical Association, the FDA implemented a moratorium on all advertising in directed to patients. Liz Moench, who was then head of marketing at Boots USA and is now president and CEO of MediciGlobal, said: "We thought that way we could navigate this quagmire of FDA indecisiveness, but they were really grappling with how to address labeling and issues of communication."
In 2002, the Secretary of Health and Human Services began requiring all draft FDA regulatory letters, including letters related to advertising violations, to be reviewed and approved by the FDA's Office of Chief Counsel before they are issued.
On 2 August 2005, Pharmaceutical Research and Manufacturers of America released its Guiding Principles on Direct to Consumer Advertisements About Prescription Medicines, with the intent to stop congressional action to end industry self-regulation.
This great amount of advertising has been successful in raising the prescription rate of DTC drugs by 34.2%, compared to only a 5.1% increase in other prescriptions. DTC advertisements have also been shown to influence the physiological efficacy of branded drugs.
These and many other aspects of DTC advertising made it very controversial among public health officials and physicians.
Consumer vulnerability to deceptive advertising is also particularly acute in the area of financial services. Individuals often have little knowledge of the workings of credit, leases, and security agreements. It is sometimes difficult to obtain information on such subjects that would be meaningful to the average consumer, so it is especially important that consumers be on guard against misleading or fraudulent advertisement. Because of the great inequality of bargaining power in this area, the government often backs up the consumer with protective laws.
New media and the evolution of direct-to-consumer advertising
Emerging media channels are causing the consumer channel mix to become increasingly fragmented. Individuals are no longer limited to just the television or newspaper to obtain their entertainment, news, and information, but can access content via websites, online video, social networks, mobile devices, and a variety of other ways. Consumers are especially shifting to new media sources for health and pharmaceutical information – over 145 million U.S. adults looked up health information online in 2008.
The pharmaceutical industry as a whole has not been as quick as other sectors to jump on the digital marketing bandwagon, in part due to unclear guidelines from the FDA. Nonetheless, many direct-to-consumer (DTC) marketers are beginning to recognize the opportunities that new media offers for reaching consumers. Though the vast majority of DTC budgets are still allocated to traditional offline media such as television, newspaper, magazine and radio, marketers are beginning to shift some of their spending to digital activities such as product websites, online display advertising, search engine marketing, social media campaigns, and mobile advertising. Regardless of the advertising channel, pharmaceutical drug advertisers are continuing to increase the amount of money spent on DTC advertising with an increase of 330% from 1996 to 2005.
- MediciGlobal (2011). Elizabeth (Liz) Moench - President and CEO. Retrieved from http://mediciglobal.com/about/liz_moench.
- Donohue, J. M., Cevasco, M., & Rosenthal, M. B. (2007). A Decade of Direct-to-Consumer Advertising of Prescription Drugs. New England Journal of Medicine, 357(7), 673-681.
- Arnold, Matthew (2006-10-01). 40 years of DTC. MMM, 1 October 2006. Retrieved from http://www.mmm-online.com/40-years-of-DTC/article/35502/
- Sheehan, Kim. Controversies in Contemporary Advertising; Sage Publications, Thousand Oaks, CA, 2003; pp 209-215.
- Emir Kamenica, Robert Naclerio, and Anup Malani. PNAS 2013. doi:10.1073/pnas.1012818110
- Kerber, Ross. Doctors Criticize Sleeping-Pill Ad (Lunesta from Sepracor Inc.). Boston Globe, Boston, Aug. 18, 2005, p HS05.
- Board of Governors of the Federal Reserve System. 1981. What Truth in Lending Means to You
- Rist, Marilee C. 1989. Mass Marketers Have a Sweet Deal for You, but There Are Strings Attached. American School Board Journal (176)9, 20-24.
- Kravitz, R. L.; Epstein, R. M.; Feldman, M. D.; Franz, C. E.; Azari, R.; Wilkes, M. S.; Hinton, L.; Franks, P. (2005). "Influence of Patients' Requests for Direct-to-Consumer Advertised Antidepressants - A Randomized Controlled Trial". JAMA 293 (16): 1995–2002. doi:10.1001/jama.293.16.1995. PMC 3155410. PMID 15855433.
- Wilkes, M. S.; Bell, R. A.; Kravitz, R. L. (2000). "Direct-to-consumer prescription drug advertising: Trends, impact, and implications". Health Affairs 19 (2): 110–128. doi:10.1377/hlthaff.19.2.110. PMID 10718026.
- Mintzes, B.; Barer, M. L.; Kravitz, R. L.; Kazanjian, A.; Bassett, K.; Lexchin, J.; Evans, R. G.; Pan, R.; Marion, S. A. (2002). "Influence of direct to consumer pharmaceutical advertising and patients' requests on prescribing decisions: Two site cross sectional survey". BMJ 324 (7332): 278–279. doi:10.1136/bmj.324.7332.278. PMC 65061. PMID 11823361.
- Donohue, J. M.; Cevasco, M.; Rosenthal, M. B. (2007). "A Decade of Direct-to-Consumer Advertising of Prescription Drugs". New England Journal of Medicine 357 (7): 673–681. doi:10.1056/NEJMsa070502. PMID 17699817.
- Holmer, Alan F. (January 27, 1999). "Direct-to-Consumer Prescription Drug Advertising Builds Bridges Between Patients and Physicians". JAMA 281 (4): 380–382. doi:10.1001/jama.281.4.380.
- Hollon, Matthew F. (January 27, 1999). "Direct-to-Consumer Marketing of Prescription DrugsCreating Consumer Demand". JAMA 281 (4): 382–384. doi:10.1001/jama.281.4.382.
- Woloshin, S.; Schwartz, L. M.; Tremmel, J.; Welch, H. G. (2001). "Direct-to-consumer advertisements for prescription drugs: What are Americans being sold?". The Lancet 358 (9288): 1141. doi:10.1016/S0140-6736(01)06254-7.
- Bell, R. A.; Kravitz, R. L.; Wilkes, M. S. (1999). "Direct-to-consumer prescription drug advertising and the public". Journal of General Internal Medicine 14 (11): 651–657. doi:10.1046/j.1525-1497.1999.01049.x. PMC 1496757. PMID 10571712.
- Bloss, C. S.; Schork, N. J.; Topol, E. J. (2011). "Effect of Direct-to-Consumer Genomewide Profiling to Assess Disease Risk". New England Journal of Medicine 364 (6): 524–534. doi:10.1056/NEJMoa1011893. PMID 21226570.
- Frosch, D. L.; Krueger, P. M.; Hornik, R. C.; Cronholm, P. F.; Barg, F. K. (2007). "Creating Demand for Prescription Drugs: A Content Analysis of Television Direct-to-Consumer Advertising". The Annals of Family Medicine 5: 6. doi:10.1370/afm.611.
- McGuire, A. L.; Burke, W. (2008). "An Unwelcome Side Effect of Direct-to-Consumer Personal Genome Testing - Raiding the Medical Commons". JAMA 300 (22): 2669–2671. doi:10.1001/jama.2008.803. PMC 2789655. PMID 19066388.
- Wolfe, S. M. (2002). "Direct-to-Consumer Advertising — Education or Emotion Promotion?". New England Journal of Medicine 346 (7): 524–526. doi:10.1056/NEJM200202143460713. PMID 11844857.
- Calfee, John E. (Fall 2002). "Public Policy Issues in Direct-to-Consumer Advertising of Prescription Drugs". Journal of Public Policy & Marketing (American Marketing Association) 21 (2): 174–193. doi:10.1509/jppm.184.108.40.20680.
- Hudson, Kathy; Javitt, Gail; Burke, Wylie; Byers, Peter; ASHG Social Issues Committee (September 2007). "ASHG Statement* on Direct-to-Consumer Genetic Testing in the United States". American Journal of Human Genetics 81 (3): 635–637. doi:10.1086/521634. PMC 1950839.
- Kornfield, R.; Donohue, J.; Berndt, E. R.; Alexander, G. C. (2013). "Promotion of Prescription Drugs to Consumers and Providers, 2001–2010". PLoS ONE 8 (3): e55504. doi:10.1371/journal.pone.0055504.
- Educating the Consumer about Advertising: Some Issues - from the Education Resources Information Center Clearinghouse on Reading and Communication Skills, Bloomington, Indiana.
- Direct to Consumer Advertising in the United States SourceWatch: A Project of the Center for Media and Democracy
-  40 years of DTC by Matthew Arnold/Medical Marketing and Media]
-  Catch the New Pharmaceutical Marketing Wave: Trends & Strategies for Reaching Today's Healthcare Consumer