The Consumer Brief Summary FDA’s New Thinking Regarding Risk Communication
New evidence — and comments from the pharma industry — motivated the FDA to issue “revised draft guidance” on February 9, 2015, titled “Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs.”
The new guidelines jettison the “traditional approach” to fulfilling the brief summary requirement and replaces it with what the FDA calls the “Consumer Brief Summary.”
What no one, including the FDA, is talking about, however, is the “fair balance” section of Rx drug ads.
This article summarizes the new guidelines and reviews the need for additional guidelines that specifically address the fair balance section of DTC print ads.
Topics (partial list):
- Anatomy of a DTC Print Ad
- Consumer Brief Summary
- Facts Box
- What About Fair Balance?
- Consumer Attitudes Concerning Drug Ads
- Fair Balance Warning Letters
- “Reasonable Consumer” & Fair Balance
- Should Digital Marketers Take Note?
Download the full article (PDF file) here:
Issue: Vol. 14, No. 2: February 2015