FDA: Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs

This revised draft guidance provides recommendations on the disclosure of risk information in prescription drug product advertisements and promotional labeling in print media directed toward consumers with respect to the brief summary requirement and the requirement that adequate directions for use be included with promotional labeling. The recommendations describe an alternative disclosure approach that FDA refers to as a consumer brief summary. This revised draft guidance does not focus on the presentation of risk information in the main body of promotional labeling or advertisements and does not apply to promotional materials directed toward health care professionals.