The Tip of the Iceberg of Misleading Online Advertising Comment on "Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters".

Barbara Mintzes

doi:10.15171/ijhpm.2016.19

Abstract

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.

Highlights

Most industrialized countries, with the exception of the United States and New Zealand, prohibit direct-to-consumer advertising (DTCA) of prescription-only medicines as a health protection measure
“trouble spots in online direct-to-consumer prescription drug promotion: a content analysis of FDA warning letters,” Hyosun Kim analyzed US Food and Drug Administration (FDA) regulatory actions concerning online DTCA over a 10-year period, from 2005 and 2014.4 This is a comprehensive analysis of the US regulatory experience with online DTCA, which provides important insights into the types of information and activities the FDA has judged to be in violation of US law
Egilman and Druar carried out a review of fraudulent pharmaceutical marketing in social media, extending beyond the examples highlighted in FDA letters.[7]

Summary

Introduction

With the exception of the United States and New Zealand, prohibit direct-to-consumer advertising (DTCA) of prescription-only medicines as a health protection measure. “trouble spots in online direct-to-consumer prescription drug promotion: a content analysis of FDA warning letters,” Hyosun Kim analyzed US Food and Drug Administration (FDA) regulatory actions concerning online DTCA over a 10-year period, from 2005 and 2014.4 This is a comprehensive analysis of the US regulatory experience with online DTCA, which provides important insights into the types of information and activities the FDA has judged to be in violation of US law.

Results

Conclusion