Direct-to-consumer advertising

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Direct-to-consumer advertising (DTC advertising) usually refers to the marketing of pharmaceutical products but also applies to the direct marketing of medical devices, consumer diagnostics and sometimes financial services. This form of advertising is directed toward patients, rather than healthcare professionals. The rhetorical objective of direct-to-consumer advertising is to directly influence the patient-physician dialogue in order to increase sales of a particular pharmaceutical drug.[1]

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.[2] 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[edit]

To date three nations permit DTC in the pharmaceutical industry [3][4]

  • New Zealand (1981)
  • United States (1985)[4][5]
  • 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 of non-prescription medication, with restrictions on the type of drug and words and images that can be used, among other things.[6]

Pharmaceutical industry controversy[edit]

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.[7]

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.[8]

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.[9]

This great amount of advertising has been successful in raising the prescription rate of DTC drugs by 34.2% from 1998 to 1999, compared to only a 5.1% increase in other prescriptions during the same time.[10]

The apparent commercial success of DTC advertising drew criticism from public health officials and physicians.[11]

On 17 November 2015, the American Medical Association called for a ban on all U.S. prescription drug and medical device advertising directly to consumers. Representatives of the leading physician's association argued that such commercial broadcasts encourage patients to take medications unnecessarily and to choose more expensive drugs. However, such a ban would require authorization by the United States Congress.[12]

On 4 March 2016, Senator Al Franken introduced a bill to Congress that would eliminate tax breaks for pharmaceutical companies advertising directly to consumers. In a similar move, representative Rosa DeLauro called for a three-year moratorium on advertising of newly approved prescription drugs. Such bans on advertising have faced substantial criticism by the pharmaceutical industry. Representatives from Pharmaceutical Research and Manufacturers of America (PhRMA) stated that drug advertising campaigns are aimed at providing consumers with information to become actively involved in their own health care.[13]

Controversy in the U. S.[edit]

Potential Benefits to DTC marketing[edit]

From 1997 to 2001, spending on research and development in the US increased 59% while spending on promoting drugs directly to patients increased 145%.[14] This shows a correlation between spending on drug promotion, and drug research.

Direct to consumer marketing may help forgetful patients to refill prescibed medications.[15] Some experts suggest that direct to consumer marketing increases the involvement of patients in their own healthcare.[14] This increase in involvement could potentially help said patients become more proactive in their own health issues, and more informed on the risks of any therapies.

Direct to consumer marketing is suggested to facilitate discussions between patients and their doctors, starting important conversations that would otherwise not occur.[16]

This can further facilitate the diagnosis of diseases and disorders which would otherwise go unnoticed.

DTC advertising, amongst other patient education initiatives, can educate consumers and patients about therapeutic options that may not have been proactively mentioned by their healthcare professional. It is considered to be a vital opportunity for the public to be aware of what is available to them and engage in an educated discussion with their doctor.

Potential Hazards to DTC marketing[edit]

The advertisements depicting pharmaceuticals can create an unrealistic expectation of a "one-pill-for-every-ill" in patients. These patients may expect that a disease as complex as depression can be fixed with medication alone, and cause patients to not take initiative to take other essential procedure to treat disorders such as depression, such as exercise, and eating healthy.[14]

When new drugs are marketed directly to patients, the use of these drugs accelerates, and the long term, or rare symptoms/reactions have not yet had enough trials to have fully been explored. Usually only small premarketing clinical trials are done on drugs freshly released on the market. These trials have a limited ability to detect serious adverse effects that are less common, have long induction period, or result from interaction with other agents or patient characteristics.[17]

Many pharmaceutical advertisements tend to contain emotional appeals, rather then data, to support their product. This prevents patients from making informed decisions regarding their treatment options.[18]

Financial services[edit]

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.[19][20]


  1. ^ Mogull, Scott A.; Balzhiser, Deborah (September 2015). "Pharmaceutical Companies Are Writing the Script for Health Consumerism". Commun. Des. Q. Rev. 3 (4): 35–49. ISSN 2166-1200. doi:10.1145/2826972.2826976. 
  2. ^
  3. ^ Bulletin of the World Health Organization. Direct-to-consumer advertising under fire. The World Health Organization (WHO). Retrieved 4 January 2017.
  4. ^ a b Mogull, Scott A. (2008). "Chronology of Direct-to-Consumer Advertising Regulation in the United States". AMWA Journal. 23: 3. 
  5. ^
  6. ^
  7. ^ Ventola, C. Lee. "Direct-to-consumer pharmaceutical advertising: therapeutic or toxic?." Pharmacy and Therapeutics 36.10 (2011): 669.
  8. ^ 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. PMID 17699817. doi:10.1056/nejmsa070502. 
  9. ^ Arnold, Matthew (2006-10-01). 40 years of DTC. MMM, 1 October 2006. Retrieved from
  10. ^ Sheehan, Kim. Controversies in Contemporary Advertising; Sage Publications, Thousand Oaks, CA, 2003; pp 209-215.
  11. ^ Kerber, Ross. Doctors Criticize Sleeping-Pill Ad (Lunesta from Sepracor Inc.). Boston Globe, Boston, Aug. 18, 2005, p HS05.
  12. ^ E Silverman (2015). "American Medical Association wants to ban drug ads to consumers". STAT (Pharmalot). Retrieved 4 January 2017.
  13. ^ E Silverman (2016)."Lawmaker seeks to end tax breaks for consumer drug ads". STAT (Pharmalot). Retrieved 4 January 2017.
  14. ^ a b c Hollon, Matthew F. (2004-02-01). "Direct-To-Consumer Marketing of Prescription Drugs". CNS Drugs. 18 (2): 69–77. ISSN 1172-7047. doi:10.2165/00023210-200418020-00001. 
  15. ^ Holmer, Alan F. (2002-02-14). "Direct-to-Consumer Advertising — Strengthening Our Health Care System". New England Journal of Medicine. 346 (7): 526–528. ISSN 0028-4793. PMID 11844858. doi:10.1056/NEJM200202143460714. 
  16. ^ Holmer, Alan F. "Direct-to-Consumer Prescription Drug Advertising Builds Bridges Between Patients and Physicians". JAMA. 281 (4). doi:10.1001/jama.281.4.380. 
  17. ^ Lyles, Alan (2003-11-28). "Direct Marketing of Pharmaceuticals to Consumers". doi:10.1146/annurev.publhealth.23.100901.140537. Retrieved 2017-04-13.  External link in |website= (help)
  18. ^ Woloshin, Steven; Schwartz, Lisa M; Tremmel, Jennifer; Welch, H Gilbert (2001-10-06). "Direct-to-consumer advertisements for prescription drugs: what are Americans being sold?". The Lancet. 358 (9288): 1141–1146. ISSN 0140-6736. doi:10.1016/s0140-6736(01)06254-7. 
  19. ^ Board of Governors of the Federal Reserve System. 1981. What Truth in Lending Means to You
  20. ^ 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.

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