New evidence -- and comments from the pharma industry -- motivated the FDA to issue "revised draft guidance" on February 9, 2015, titled "Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and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. Download the full text PDF file here: