On February 6, 2015, the U.S. Food and Drug Administration (FDA) issued a revised draft guidance titled Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs. This revised guidance replaces a draft guidance issued by FDA in 2004. In the revised draft guidance, FDA advises companies to stop using the full package insert (PI) to satisfy the “brief summary” and “adequate directions for use” requirements for prescription drug print advertisements and promotional labeling targeted to consumers. FDA urges firms to instead communicate important risk information in a more consumer–friendly format, such as a Drug Facts box format or question and answer format. FDA also recommends, among other things, that the consumer brief summary carry over elements of the main body of the ad (such as logos and branded colors) to establish a perceptual link between the consumer brief summary and promotional piece.

FDA is currently accepting comments to the docket on this revised draft guidance. The deadline for submitting comments is May 11, 2015.