Direct-to-consumer advertising (DTC advertising) sometimes refers to the marketing of pharmaceutical products but applies 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 three nations permit DTC in the pharmaceutical industry (Nation, year of legalization)
- New Zealand (1981)
- United States (1997)
- Brazil (2008) - In 2008 a new resolution from ANVISA (Control Agency for Sanitary Vigilance)- Resolution 96 from December 17 was released, with focus on medication advertisement. It allows direct-to-consumer advertising, with restrictions on the type of drug and words and images that can be used, among other things.
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.
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.
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.
- Ventola, C. Lee. "Direct-to-consumer pharmaceutical advertising: therapeutic or toxic?." Pharmacy and Therapeutics 36.10 (2011): 669.
- 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.
- 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.
- 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.
- 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.
-  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