Regulating Direct-to-Consumer Advertising of Prescription Drugs in the Digital Age
Abstract
:1. Introduction
1.1. The Pharmaceutical Industry’s Move towards Online Marketing
1.2. Patients Go Online for Health Information
2. Regulating DTCA in the Digital Age
2.1. Food and Drugs Act and Regulations
2.2. Calls for Specific Social Media Guidelines
2.2.1. Social Media Guidance in the US
2.2.2. The Challenges of Issuing Specific Social Media Guidance
3. The New Dynamics of DTCA in Social Media
3.1. User-Generated Content on Industry-Sponsored Platforms
3.1.1. The Burden of Monitoring and Moderating
3.1.2. Social Media Testimonials
3.2. Consumer Propagation and Viral Marketing
3.3. Targeted Marketing
Search Engine Advertising
3.4. The Role of Unbranded Advertising
4. Regulatory Aspects
4.1. Direct Government Regulation
4.1.1. Challenges in Enforcement
4.1.2. Increasing Deterrence
4.1.3. Recognizing the Limitations of Government Oversight
4.2. Independent Third-Party Oversight
Proposals for Mandatory Preclearance
4.3. Industry Self-Regulation
4.3.1. The Complaint Process
4.3.2. Self-Regulation of Online DTCA
5. Conclusions
Acknowledgements
Abbreviations
ASC | Advertising Standards Canada |
DTCA | direct-to-consumer advertising |
FDA | Food and Drug Administration |
PAAB | Pharmaceutical Advertising Advisory Board |
Rx&D | Canada’s Research-based Pharmaceutical Companies |
UGC | user-generated content |
Conflicts of Interest
References and Notes
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- 1Defining the scope of social media is often an elusive task since as the technology and its uses evolve, the definition of social media evolves as well. For the purposes of this paper, the discussion of the pharmaceutical industry’s use of social media will be focused on what Liang and Mackey refer to as “eDTCA 2.0” which includes social media marketing tools such as Facebook and Twitter, blogs and RSS feeds (Rich Site Summary, also known asreally simple syndication) that provide company-sponsored Web feed communications to users, YouTube channels dedicated to marketing videos, and mobile applications for smartphones, and other mobile technologies [1]. However, while Liang and Mackey focus of branded DTCA, this paper also considers the role of unbranded health information provided by the pharmaceutical industry through the Internet and social media.
- 2For example, one brand that has shown particular success in engaging with consumers through customized online health management tools is AstraZeneca’s heartburn drug Nexium. Tools on the Nexium website include “the Trigger Checker, a searchable database of acid-reflux trigger ingredients and suggestions for milder substitutes; the Meal Planner, a weekly menu builder with heartburn-preventing recipes; and the Personal Fitness Planner, a tool that creates customized exercise plans designed by a virtual fitness trainer that can be saved on site” ([9], p. 32).
- 3A well-publicized example of this problem is the case of the infamous drug Vioxx, which was withdrawn from the market in 2004 after a clinical trial revealed that long-term use of this pain medication was associated with a nearly doubled risk of heart attack or stroke [19]. Although Vioxx had never been proven to be more effective than older, cheaper alternatives, an aggressive DTCA campaign for Vioxx—Merck spent more than US$500 million dollars advertising Vioxx during its five years on the market, which generated sales of more than US$2.5 billion [3]—led to the drug being prescribed to a very large number of people soon after its launch, and ultimately, to a correspondingly higher number of adverse drug events [20]. Consequently, the Vioxx crisis stands as a stark reminder that the use of new drugs should be approached with caution and, unless new products represent a significant improvement in safety or efficacy over existing products, they should not routinely replace standard treatments until sufficient evidence has been gathered to support their wide scale use.
- 4For example, on the Canadian Living Well with Psoriasis website [47] sponsored by Janssen there is an Impact Questionnaire and a Severity Calculator aimed at determining the seriousness of a user’s psoriasis. Even if the user indicates that psoriasis never impacts their life, the Impact Questionnaire still suggests that the user should consult their doctor if they have any particular concerns. The Severity Calculator inquires about whether the patient is receiving treatment, if the treatment is working, and whether there is anything about current treatment that the patient does not like—nearly all responses lead to the conclusion that the user should talk to their doctor about different treatment options. The site even provides a “Dermatologist Finder” tool to help users locate a dermatologist in their area.
- 5It is worth recognizing that the pharmaceutical industry is certainly not the worst offender when it comes to the production of questionable health information. The Internet is brimming with claims of miracle cures, natural remedies, and new age treatments from dubious sources. Unfortunately, many consumers lack the knowledge necessary to discern between legitimate and questionable sources of health information. However, there are already some initiatives aimed at facilitating access to reliable health information online. One such initiative is HONcode, which is described as “the oldest and most used ethical and trustworthy code for medical and health related information available on [the] Internet.” The HONcode website provides a search engine where users can seek out health information on a wide range of sites that have undertaken to respect the HONcode ethical standard of offering quality health information [54].
© 2014 by the author; licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution license (http://creativecommons.org/licenses/by/3.0/).
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Gibson, S. Regulating Direct-to-Consumer Advertising of Prescription Drugs in the Digital Age. Laws 2014, 3, 410-438. https://doi.org/10.3390/laws3030410
Gibson S. Regulating Direct-to-Consumer Advertising of Prescription Drugs in the Digital Age. Laws. 2014; 3(3):410-438. https://doi.org/10.3390/laws3030410
Chicago/Turabian StyleGibson, Shannon. 2014. "Regulating Direct-to-Consumer Advertising of Prescription Drugs in the Digital Age" Laws 3, no. 3: 410-438. https://doi.org/10.3390/laws3030410