Direct-to-consumer advertising

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Direct-to-consumer (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. Avenues for DTC advertising include TV, print, radio and other mass and social media. This form of advertising is directed toward patients, rather than healthcare professionals. The objective of direct-to-consumer advertising by a pharmaceutical company is to promote a particular medication to the patient directly.[1]

The Food and Drug Administration is responsible for regulating DTC advertising for prescription medications in the United States, and the Federal Trade Commission (FTC) is responsible for oversight on over-the-counter medications. The FDA's latest version of guidelines, though still in draft form, for pharmaceutical drug advertising was updated in 2009.[2]

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.

Types[edit]

DTC advertising can come in different types:[3]

Type of Advertisement Description
Product Claim Advertisements Provides medication name, at least one FDA-approved indication, safety information, and benefits.
Reminder Advertisements Provides name of the medication, but does not include the drug's class, indication, and safety information. This type of advertisement only applies to drugs without a black box warning.
Help-Seeking Advertisements Informs about a specific medical condition without naming a specific medication. Not regulated by FDA.
Other Promotional Materials Brochures, drug companies mailing or handing out materials to consumers. Includes any products that may have the name of the drug provided by the pharmaceutical company.

Countries permitting DTC[edit]

To date four nations permit DTC in the pharmaceutical industry:[4][5]

  • New Zealand (1981)[attribution needed]
  • United States (1985)[5][6]
  • 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.[7] Advertisements for prescription medications can only appear in scientific, medical, or health professional journals.[8]
  • Hong Kong (1953)[9]

FDA regulations of the DTCPA in the United States[edit]

FDA exercise regulation of DTCPA under the legal framework stipulated within the Federal Food, Drug and Cosmetic Act and regulations therein. The nonprescription or over-the-counter (OTC) drug products fall under a direct jurisdiction of the Federal Trade Commission or FTC. The central theme of the FDA oversight is to ensure communication of accurate and balanced information as it relates to drug product benefit and safety. FDA has adopted a three pronged strategy involving exercising regulatory surveillance, enforcement, and education program coupled with ensuring a productive communication of FDA-approved labeling including any safety warning/recall to both clinicians and general population.

In addition, FDA as online website and portal which educate on how to discern acceptable vs unacceptable drug product advertisement and report any discrepancies directly to FDA's Office of Prescription Drug Promotion using following link.

FDA’s Office of Prescription Drug Promotion using the following link

https://www.fda.gov/Drugs/ResourcesForYou/Consumers/PrescriptionDrugAdvertising/default.htm

https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm090224.htm

FDA - Challenges to DTCPA Oversight[edit]

DTPCA within the United States is regulated by the FDA. Under their oversight they may enforce regulations and take action against those who do not abide by the DTCPA rules. However, their authority and oversight has declined within recent years. In 2002, the Secretary of HHS required all draft warning letters to be directly reviewed by the FDA's Office of Chief Counsel prior to being issued.[10] This has caused frequent delays and sometimes regulatory letters would be sent out after an advertisement campaign has ended. This conclusion was based on the data that despite an increase in the number of regulatory letters being sent to the FDA for review, there has been a drastic decrease in the number of FDA citations.[10] Critics suggest this delay in review is coupled with the disproportionately low funding and staff afforded to the FDA. In 2010 reports estimate the industry spent more than twice the entire budget of the FDA on DTCA alone.[11]

History[edit]

Direct-to-consumer pharmaceutical advertising (DTCPA) laws and regulations in the United States have gradually become more relaxed since they were first introduced in the 1960s.  Consequently, expenditures on advertisements for prescription drugs in the United States have grown to approximately $4.5 billion per year.[12]

In 1962 Congress gave the Food and Drug Administration (FDA) the authority to regulate prescription drug labeling and advertising, but the FDA did not establish implementing regulations until 1969.[12][13] Pharmaceutical companies shifted the focus of their marketing efforts to licensed medical doctors in the 1970s, as the FDA mandated that only doctors could prescribe medicine.[13]

After a series of Patient Rights campaigns in the 1970s persuaded a large segment of the population to be actively involved in their own medical care, the drug company Pfizer launched the first pharmaceutical direct-to-consumer campaign in 1980, promoting its brand but not marketing any prescription medication.[12]  In 1981, Boots aired the first targeted drug advertisement for the drug Rufen, promoting the pain killer as a cheaper alternative to leading brands. Soon after Merck launched a campaign promoting its pneumonia vaccine.[13]

DTC marketing significantly increased starting in 1997, after the FDA suggested ways pharmaceutical companies could meet what had previously been a legally vague regulatory provision; the FDA also exempted certain types of advertisements from providing a full summary of major side effects and contraindications of a drug's effectiveness.[13] In 2004, the FDA further relaxed DTCPA regulations to require only a brief description of the drug and its side effects – provided that consumers could access full summary information elsewhere.[12]

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.[14]

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.[15]

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.[16]

The apparent commercial success of DTC advertising drew criticism from public health officials and physicians.[17]

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.[18]

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.[19]

On 15 October 2018, the Trump administration made a proposal that would require pharmaceutical companies to make medication prices transparent on their television advertisements. The proposal pertains to all prescription medications that cost more than $35 a month, with the price being clearly and legibly revealed at the end of the advertisement. However, according to Rachel Sachs, an associate professor of law at Washington University in St. Louis, the "government is unwilling to take enforcement action" and "will take many months if not years for this regulation to be implemented".[20]

Pros[edit]

Economic[edit]

Supporters of DTCPA argue that advertisements increase competition which leads to lower prescription drug prices and new development, citing, for instance, that between 1997 to 2001, spending on research and development in the US increased 59% while spending on promoting drugs directly to patients increased 145%. However, other experts have asserted that funding for R&D is determined by several other factors.[21][12]

Public health[edit]

Arguments in favor of DTCPA assert that advertising informs consumers of new treatment options, generating new doctor visits and thereby reducing the rate of undiagnosed illnesses. 

DTC advertising, among other patient education initiatives, can educate consumers and patients about therapeutic options that may not have been proactively mentioned by their healthcare professional. Proponents of DTCPA claim this provides a vital opportunity for the public to be aware of what is available to them and to engage in an educated discussion with their doctor. According to one study, every additional $28 spent on DTCPA prompts one patient visit within the following 12 months. Another study observes that DTCPA promotes communication between patients and their doctors about medications. Thirty percent of Americans indicate they talk with their doctor about a medicine they saw on TV.[22]

In addition, surveys show that increased advertising has had a positive impact on the degree to which people adhere to a given course of treatment – but only among those who were already on medication prior to exposure to DTCPA. Among this population, a 10% increase in exposure to drug advertising increases the rate of adherence between 1% and 2%.[23]

Cons[edit]

Economic[edit]

Some studies have asserted that DTCPA misleads patients into demanding heavily-advertised drugs, leading to superfluous or sub-optimal treatment.  For example, the Centers for Disease Control and Prevention have determined that 47% of all antibiotics prescribed in the United States are unnecessary, imposing significant additional costs on affected households.[24]  Another study found that young people living in West Palm Beach, Florida found that a 10% increase in advertising expose increased the total number of prescriptions by 5%; a higher percentage change than in Denver, Colorado – where DTCPA expenditures per person are lower.[25] Critics also argue that resources spent on DTCPA could otherwise be spent on developing new drugs and medical therapies.  Nine of the 10 largest pharmaceutical companies worldwide spend more money on sales and marketing than on research and development.[26] US pharmaceutical companies are estimated to have spent 5.2 billion dollars on prescription drug advertising in 2015 most of which was spend on television advertising.[27]

Doctor-Patient Relationship[edit]

When consumers approach their doctor with a health concern, or to request a change in medication for a condition they already have, often their first and most persuasive source of information was a pharmaceutical advertisement.  This leads consumers to direct their doctors’ visits from the start by prompting a conversation about a certain drug or course of treatment.  Doctors may be more likely to prescribe the medicine patients requested even when it may not be the most cost-effective, medically sound or safe course of treatment.  Of those patients who sought medical treatment because of an advertisement, 44% report their doctor prescribed the medication that they requested.[23] 47% of doctors expressed feeling pressured to prescribe a drug because their patient requested it by name.[28] When new drugs are marketed directly to patients, the use of these drugs accelerates, even though trials and testing may not have yet had enough time to identify long-term side effects or rare reactions to the drug. Recently-released drugs usually are only tested in small pre-marketing clinical trials.[29]

New demand for a particular drug can also create adverse public health harm.  A higher rate of antibiotic consumption – driven in part by DTCPA – is creating anti-biotic resistant infection strains that in turn pose a public health hazard.[24]

DTCPA has contributed to illicit drug use of certain pharmaceutical drugs, as drug addicts seek out prescriptions based on their greater knowledge of drugs available on the market.[23]

Drug Safety[edit]

Vioxx was heavily marketed directly to US consumers soon after FDA approval in 1999 and was widely prescribed; when the drug was withdrawn for safety reasons in 2004, Merck, its developer, and the FDA were criticized for the DTC campaign and received DTCA can lead to patients using newer drugs.[30] Advertisements generally begin within a year of drugs entering the market, before postmarketing surveillance is available to see if adverse effects emerge, which increases the risk of harm.[30] In the early 2000s the FDA's resources to screen DTC ads were not keeping pace with the number of ads being produced, raising the risk that the inappropriate ads were not removed.[30]

Gender stereotypes[edit]

Some drug ads have "gendered" diseases in ways that don't reflect actual epidemiology. Women's bodies have also been objectified to mask or distract from unpleasant aspects of diseases. The marketing of drugs for inflammatory bowel disease has been called out on both counts.[31] Similarly the marketing of Gardasil was primarily aimed at young women, when sexually transmitted diseases are carried by, and affect, both genders.[31]

Disease mongering[edit]

Pharmaceutical companies' desire to make a profit can lead to marketing more drugs to more people. The bounds for what is considered "disease" may broaden in the process called disease mongering. Advertisements display “unfortunate facts of life” like wrinkling or baldness as a disease to be treated with drugs.[28]

References[edit]

  1. ^ Mogull SA, Balzhiser D (September 2015). "Pharmaceutical Companies Are Writing the Script for Health Consumerism". Commun. Des. Q. Rev. 3 (4): 35–49. doi:10.1145/2826972.2826976.
  2. ^ Center for Drug Evaluation and Research. "Guidances (Drugs) - Advertising". www.fda.gov.
  3. ^ "Basics of Drug Ads". U.S. Food & Drug Administration. 2015-06-19. Retrieved 2018-11-01.
  4. ^ Bulletin of the World Health Organization. Direct-to-consumer advertising under fire. The World Health Organization (WHO). Retrieved 4 January 2017.
  5. ^ a b Mogull SA (2008). "Chronology of Direct-to-Consumer Advertising Regulation in the United States". AMWA Journal. 23: 3.
  6. ^ "WHO - Direct-to-consumer advertising under fire". www.who.int.
  7. ^ "RESOLUÇÃO-RDC Nº 96, DE 17 DE DEZEMBRO DE 2008" (PDF). Retrieved August 13, 2017.
  8. ^ "Advertising Regulation for Medication in Brazil". The Brazil Business. Retrieved 2018-02-21.
  9. ^ "Drug Office - Undesirable Medical Advertisements Ordinance".
  10. ^ a b Donohue JM, Cevasco M, Rosenthal MB (August 2007). "A decade of direct-to-consumer advertising of prescription drugs". The New England Journal of Medicine. 357 (7): 673–81. doi:10.1056/NEJMsa070502. PMID 17699817.
  11. ^ Parnes B, Smith PC, Gilroy C, Quintela J, Emsermann CB, Dickinson LM, Westfall JM (January 2009). "Lack of impact of direct-to-consumer advertising on the physician-patient encounter in primary care: a SNOCAP report". Annals of Family Medicine. 7 (1): 41–6. doi:10.1370/afm.870. PMC 2625841. PMID 19139448.
  12. ^ a b c d e Ventola CL (October 2011). "Direct-to-Consumer Pharmaceutical Advertising: Therapeutic or Toxic?". P & T. 36 (10): 669–84. PMC 3278148. PMID 22346300.
  13. ^ a b c d Donohue J (2006). "A history of drug advertising: the evolving roles of consumers and consumer protection". The Milbank Quarterly. 84 (4): 659–99. doi:10.1111/j.1468-0009.2006.00464.x. PMC 2690298. PMID 17096638.
  14. ^ Donohue JM, Cevasco M, Rosenthal MB (August 2007). "A decade of direct-to-consumer advertising of prescription drugs". The New England Journal of Medicine. 357 (7): 673–81. doi:10.1056/nejmsa070502. PMID 17699817.
  15. ^ 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/
  16. ^ Sheehan, Kim. Controversies in Contemporary Advertising; Sage Publications, Thousand Oaks, CA, 2003; pp 209-215.
  17. ^ Kerber, Ross. Doctors Criticize Sleeping-Pill Ad (Lunesta from Sepracor Inc.). Boston Globe, Boston, Aug. 18, 2005, p HS05.
  18. ^ E Silverman (2015). "American Medical Association wants to ban drug ads to consumers". STAT (Pharmalot). Retrieved 4 January 2017.
  19. ^ E Silverman (2016)."Lawmaker seeks to end tax breaks for consumer drug ads". STAT (Pharmalot). Retrieved 4 January 2017.
  20. ^ "Should TV Drug Ads Be Forced To Include A Price? Trump's Team Says Yes". NPR.org. Retrieved 2018-11-01.
  21. ^ Hollon MF (2004-02-01). "Direct-to-consumer marketing of prescription drugs: a current perspective for neurologists and psychiatrists". CNS Drugs. 18 (2): 69–77. doi:10.2165/00023210-200418020-00001. PMID 14728054.
  22. ^ Iizuka T, Jin GZ (2005-09-01). "The Effect of Prescription Drug Advertising on Doctor Visits". Journal of Economics & Management Strategy. 14 (3): 701–727. doi:10.1111/j.1530-9134.2005.00079.x. ISSN 1530-9134.
  23. ^ a b c McKinlay JB, Trachtenberg F, Marceau LD, Katz JN, Fischer MA (April 2014). "Effects of patient medication requests on physician prescribing behavior: results of a factorial experiment". Medical Care. 52 (4): 294–9. doi:10.1097/MLR.0000000000000096. PMC 4151257. PMID 24848203.
  24. ^ a b "CDC Press Releases". CDC. Retrieved 2017-08-12.
  25. ^ "Cause and Effect: Do Prescription Drug Ads Really Work? - Knowledge@Wharton". Knowledge@Wharton. Retrieved 2017-07-28.
  26. ^ Anderson R (2014-11-06). "Pharmaceutical industry gets high on fat profits". BBC News. Retrieved 2017-08-12.
  27. ^ Orelli B (June 9, 2017). "6 Reasons Why Prescription Drug Prices Are Extremely Expensive -- The Motley Fool". The Motley Fool. Retrieved 2017-08-12.
  28. ^ a b Metzl, Jonathan. “Selling Sanity Through Gender.” Ms Magazine, Fall, 2003.
  29. ^ Lyles A (2002-05-01). "Direct marketing of pharmaceuticals to consumers". Annual Review of Public Health. 23 (1): 73–91. doi:10.1146/annurev.publhealth.23.100901.140537. PMID 11910055.
  30. ^ a b c Donohue JM, Cevasco M, Rosenthal MB (August 2007). "A decade of direct-to-consumer advertising of prescription drugs". The New England Journal of Medicine. 357 (7): 673–81. doi:10.1056/NEJMsa070502. PMID 17699817. open access publication – free to read
  31. ^ a b Fisher JA, Ronald LM (August 2010). "Sex, gender, and pharmaceutical politics: From drug development to marketing". Gender Medicine. 7 (4): 357–70. doi:10.1016/j.genm.2010.08.003. PMID 20869636.

Further reading[edit]

External links[edit]