Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: Teaching Drug Marketers How to Inform Better or Spin Better?; Comment on “Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters” (original) (raw)
Related papers
2015
Background For the purpose of understanding the Food and Drug Administration’s (FDA’s) concerns regarding online promotion of prescription drugs advertised directly to consumers, this study examines notices of violations (NOVs) and warning letters issued by the FDA to pharmaceutical manufacturers. Methods The FDA’s warning letters and NOVs, which were issued to pharmaceutical companies over a 10-year period (2005 to 2014) regarding online promotional activities, were content-analyzed. Results Six violation categories were identified: risk information, efficacy information, indication information, product labeling, material information issues, and approval issues. The results reveal that approximately 95% of the alleged violations were found on branded drug websites, in online paid advertisements, and in online videos. Of the total 179 violations, the majority of the alleged violations were concerned with the lack of risk information and/or misrepresentation of efficacy information, suggesting that achieving a fair balance of benefit versus risk information is a major problem with regard to the direct-to-consumer advertising (DTCA) of prescription drugs. In addition, the character space limitations of online platforms, eg, sponsored links on search engines, pose challenges for pharmaceutical marketers with regard to adequately communicating important drug information, such as indication information, risk information, and product labeling. Conclusion Presenting drug information in a fair and balanced manner remains a major problem. Industry guidance should consider addressing visibility and accessibility of information in the web environment to help pharmaceutical marketers meet the requirements for direct-to-consumer promotion and to protect consumers from misleading drug information. Promotion via social media warrants further attention, as pharmaceutical manufacturers have already begun actively establishing a social media presence, and the FDA has thus begun to keep tabs on social media promotions of prescription drugs.
2016
Kim’s overview of Food and Drug Administration (FDA) regulatory actions from 2005 to 2014 is a comprehensive analysis of the US regulatory experience with online direct-to-consumer advertising (DTCA) of prescription medicines. This experience is of relevance internationally as online DTCA reaches the English-speaking public globally, despite the illegality of DTCA in most countries. The most common violations were omissions or minimizations of risk information, overstatements of efficacy, unsubstantiated claims, and promotion of unapproved (“off-label”) use. Nearly one fourth of violations involved cancer drugs, raising additional concerns about patient vulnerability, limited treatment advance, and high costs. Based on content analyses of online DTCA, these cases likely reflect a small proportion of unbalanced and misleading promotional information available on the web. The FDA is only able to review a small proportion of promotional materials submitted to them, due to limited staffing, and the delay between first posting and regulatory action means that many people may be exposed to messages that are found to be inaccurate and misleading. The sheer volume of online DTCA, combined with the ability for content to shift continually, poses unique regulatory challenges.
2016
The adoption and use of digital forms of direct-to-consumer advertising (also known as “eDTCA”) is on the rise. At the same time, the universe of eDTCA is expanding, as technology on Internet-based platforms continues to evolve, from static websites, to social media, and nearly ubiquitous use of mobile devices. However, little is known about how this unique form of pharmaceutical marketing impacts consumer behavior, public health, and overall healthcare utilization. The study by Kim analyzing US Food and Drug Administration (FDA) notices of violations (NOVs) and warning letters regarding online promotional activities takes us in the right direction, but study results raise as many questions as it does answers. Chief among these are unanswered concerns about the unique regulatory challenges posed by the “disruptive” qualities of eDTCA, and whether regulators have sufficient resources and oversight powers to proactively address potential violations. Further, the globalization of eDTCA via borderless Internet-based technologies raises larger concerns about the potential global impact of this form of health marketing unique to only the United States and New Zealand. Collectively, these challenges make it unlikely that regulatory science will be able to keep apace with the continued rapid evolution of eDTCA unless more creative policy solutions are explored.
The adoption and use of digital forms of direct-to-consumer advertising (also known as " eDTCA ") is on the rise. At the same time, the universe of eDTCA is expanding, as technology on Internet-based platforms continues to evolve, from static websites, to social media, and nearly ubiquitous use of mobile devices. However, little is known about how this unique form of pharmaceutical marketing impacts consumer behavior, public health, and overall healthcare utilization. The study by Kim analyzing US Food and Drug Administration (FDA) notices of violations (NOVs) and warning letters regarding online promotional activities takes us in the right direction, but study results raise as many questions as it does answers. Chief among these are unanswered concerns about the unique regulatory challenges posed by the " disruptive " qualities of eDTCA, and whether regulators have sufficient resources and oversight powers to proactively address potential violations. Further, the globalization of eDTCA via borderless Internet-based technologies raises larger concerns about the potential global impact of this form of health marketing unique to only the United States and New Zealand. Collectively, these challenges make it unlikely that regulatory science will be able to keep apace with the continued rapid evolution of eDTCA unless more creative policy solutions are explored. Citation: Mackey TK. Digital direct-to-consumer advertising: a perfect storm of rapid evolution and stagnant regulation: Comment on: " Trouble spots in online direct-to-consumer prescription drug promotion: a content analysis of FDA warning letters.
Psychology and Marketing, 2008
A critical requirement of direct-to-consumer (DTC) drug promotion on the Internet is the concept of fair balance. This means that prescription drug Web sites should provide an accurate, balanced portrayal of the risks relative to the benefits of using prescription medications. However, one of the most pervasive findings in consumer research is that risk perceptions are often not aligned with the actual risk a consumer faces. This study examines the impact of certain presentation formats and types of risk information provided on a pharmaceutical Web site and the effect on consumers' perceptions of risk and fair balance. We find evidence of a bias of omission; that is, the risks of treating a health condition using a hypothetical prescription drug were perceived to be greater than the risk of
2016
This commentary explores the implications of increased social media marketing by drug manufacturers, based on findings in Hyosun Kim’s article of the major themes in recent Food and Drug Administration (FDA) warning letters and notices of violation regarding online direct-to-consumer promotions of pharmaceuticals. Kim’s rigorous analysis of FDA letters over a 10-year span highlights a relative abundance of regulatory action toward marketer-controlled websites and sponsored advertisements, compared to branded and unbranded social media messaging. However, social media marketing efforts are increasing, as is FDA attention to these efforts. This commentary explores recent developments and continuing challenges in the FDA’s attempts to provide guidance and define pharmaceutical company accountability in marketer-controlled and -uncontrolled claims disseminated through social media.
Proceedings of the Human Factors and Ergonomics Society, 2001
Recently, drug manufacturers have been increasingly marketing their prescription medications using Direct-to-Consumer (DTC) advertisements. The current study examines the effects of integrating and separating the risks and benefits within a prescription medication DTC web site advertisement. The study also examined the effects of presenting the risk and benefits at different levels of a web site. Two different drug web sites and two different task types (general browsing and item search) were used. Risk recall, recognition, time-on-task, click rate, and task success were measured. Results from the current study indicated that risk information was found faster, with less clicks, and remembered more often when placed on a second level page linked from the home page. However, the risk information was more difficult to find when it was placed on a fourth level page without a link on the home page. The pattern of effects with the two tasks was similar. No significant differences were found between the two drugs. A set of guidelines is provided for the development of DTC prescription drug web sites based on the results. It is beneficial (a) to present separate risk and benefit information sections and (b) to place risk and benefit information in the top section of the home page or to prominently place a link to the risk information on the home page.
Could Less be More? An Analysis of Direct to Consumer Advertising of Prescription Medicines
Prescription medicines are now frequently promoted on television, a change that has prompted strong debate over the merits of direct to consumer advertising of restricted drugs (DTCA). The debate has centred on three issues: the effect advertising has on doctor-patient relationships; the alleged pressure campaigns place on pharmaceutical budgets, and the quality of information consumers receive. This paper describes a pilot study that examined the third issue. Attempts to provide full details about a drug's properties appear to limit consumers' ability to understand and recall more fundamental information about that drug. We suggest changes to the regulations governing DTCA that may assist the conveyance of balanced information to consumers.