Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters.

Hyosun Kim

doi:10.15171/ijhpm.2015.157

Abstract

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. 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. 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. 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.

Highlights

The online promotion of prescription drugs directly to consumers has become an increasingly popular method of drug advertising in the United States
Based on an analysis of the alleged violations found in warning letters and untitled letters that have been issued to pharmaceutical manufacturers by the Food and Drug Administration (FDA) in a recent 10-year span with regard to online DTC promotion of prescription drugs, the present study aims to diagnose issues that pharmaceutical marketers should avoid in their online promotional materials to protect consumers from misleading information
The Food and Drug Administration (FDA’s) warning letters and notices of violations (NOVs), which were issued to pharmaceutical manufacturers over a recent span of 10 years, were content-analyzed

Summary

Introduction

The DTCA of prescription drugs in broadcast and print media encourages consumers to visit drug websites for further information about the product.[6] This allows advertisers to take advantage of online platforms and use more diverse approaches to reach consumers than was possible even a decade or two ago They are actively engaging with consumers online and experimenting with new online media platforms, eg, social media, establishing an online presence and promoting their prescription drugs.[7,8] as online advertising becomes an increasingly integral part of prescription drug promotion, the lack of clear guidance regarding online promotion has created challenges for pharmaceutical marketers.[7] based on an analysis of the alleged violations found in warning letters and untitled letters that have been issued to pharmaceutical manufacturers by the FDA in a recent 10-year span with regard to online DTC promotion of prescription drugs, the present study aims to diagnose issues that pharmaceutical marketers should avoid in their online promotional materials to protect consumers from misleading information. This study of FDA warning letters and notices of violations (NOVs) regarding alleged violations found in the online DTCA of prescription drugs appears to be unique in the literature at present

Objectives

Methods

Results

Conclusion