Direct-to-Consumer Promotion of Prescription Drugs on Mobile Devices: Content Analysis.

Kathryn J Aikin,Molly Lynch,Suzanne Dolina,Helen W Sullivan,Linda B Squiers

doi:10.2196/jmir.7306

Abstract

BackgroundUS Food and Drug Administration (FDA) regulations state that any prescription drug promotion that presents drug benefits to consumers must also disclose certain information about the drug’s risks in a similar manner. Nearly three-quarters of all US mobile phone subscribers use a smartphone, and over half report receiving mobile advertisements on their device.ObjectiveThe objective of this project was to investigate how prescription drugs are being promoted to consumers using mobile technologies. We were particularly interested in the presentation of drug benefits and risks, with regard to presence, placement, and prominence.MethodsWe analyzed a sample of 51 mobile promotional communications and their associated linked landing pages. We assessed the content and format of the mobile communications and landing pages with regard to presentation of drug benefits and risks.ResultsOf the 51 mobile communications we coded, 41% (21/51) were product claim communications (includes the drug name, benefits, and risks), 22% (11/51) were reminder communications (includes drug name only), and 37% (19/51) were help-seeking communications (includes information about the medical condition but not the drug name). Some of the product claim communications (5/21, 24%) required scrolling to see all the benefit information; in contrast, 95% (20/21) required scrolling to see all the risk information. Of the 19 product claim communications that presented both benefits and risks, 95% (18/19) presented benefits before risks and 47% (9/19) used a bigger font for benefits than for risks. Most mobile communications (35/51, 69%) linked to branded drug websites with both benefits and risks, 25% (13/51) linked to a landing page with benefits but no visible risks, and 6% (3/51) linked to a landing page with risks but no visible benefits. Few landing pages (4/51, 8%) required scrolling to see all the benefit information; in contrast, 51% (26/51) required scrolling to see all the risk information. Of the 35 landing pages with both benefit and risk information, 71% (25/35) presented benefits before risks and 51% (18/35) used a bigger font for benefits than for risks.ConclusionsThese results indicate that, while risks and benefits are both represented in mobile communications and their associated landing pages, they are not equally prominent and accessible. This has implications for compliance with FDA fair balance regulations.

Highlights

MethodsInformation, entertainment, and advertisement consumption has been steadily moving away from print and network television stations to more specialized and targeted digital outlets, including Internet and mobile devices
One possible cause of this could be the issuance of US Food and Drug Administration (FDA) “enforcement” warning and untitled letters about sponsored links on Internet search engines in 2009 [7], which stated that online promotion is subject to existing laws and implementing regulations [8,9]
Of the 21 communications, 2 (10%) had additional benefit information available with a link or tab, and 1 (1/21, 5%) had additional risk information available with a link or tab

Summary

Introduction

MethodsInformation, entertainment, and advertisement consumption has been steadily moving away from print and network television stations to more specialized and targeted digital outlets, including Internet and mobile devices. The US Food, Drug, and Cosmetic Act and implementing regulations state that any prescription drug promotion that presents drug benefits to consumers must disclose certain information about the drug’s risks in a similar manner. This concept of “fair balance” may be challenging in mobile promotional communications (hereafter referred to as “mobile communications”), where there are often limitations on the amount of information that can be presented. Conclusions: These results indicate that, while risks and benefits are both represented in mobile communications and their associated landing pages, they are not prominent and accessible This has implications for compliance with FDA fair balance regulations

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