Still the Great Debate - "Fair Balance" in Direct-to-Consumer Prescription Drug Advertising Comment on "Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters".

Brent L Rollins

doi:10.15171/ijhpm.2016.17

Abstract

The above titled paper examined the Food and Drug Administration's (FDA's) warning letters and notice of violations (NOV) over a 10-year period. Findings from this content analysis reinforced what has been the primary issue for prescription direct-to-consumer advertising (DTCA) since its beginning, the fair balance of risk and benefit information. As opposed to another analysis in 2026 about this still being an issue, is there anything that can be done to prevent this problem from continuing?

Highlights

In the research paper and content analysis addressed by this commentary, Hyosun Kim thoroughly examines a 10-year stretch of Food and Drug Administration (FDA) warning letters and notice of violations (NOV) to identify problem areas in online direct-to-consumer advertising (DTCA).[1]
The author’s results pointed to the Food and Drug Administration (FDA’s) focus and an area pharmaceutical manufacturers still to this day, over 18 years after the moratorium on DTCA was lifted, struggle – the ‘fair balance’ requirement in the amount of risk versus benefit information presented in any promotional item and outlet
The FDA has extensively researched consumer response to DTCA and put out guidance documents for the pharmaceutical industry to better understand how to exist in the space without consequence.[2,3,4,5]

Summary

Introduction

The above titled paper examined the Food and Drug Administration’s (FDA’s) warning letters and notice of violations (NOV) over a 10-year period. Findings from this content analysis reinforced what has been the primary issue for prescription direct-to-consumer advertising (DTCA) since its beginning, the fair balance of risk and benefit information.

Results

Conclusion