This revised draft guidance provides recommendations on the disclosure of risk information in prescription drug product advertisements and promotional labeling in print media directed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 This revised draft guidance does not focus on the presentation of risk information in the main body of promotional labeling or advertisements and does not apply to promotional materials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.
This revised draft guidance responds to stakeholder requests for specific guidance on the disclosure of risk information to consumers and incorporates recent social science research results (Aikin, O’Donoghue, et al. 2011). This revised draft guidance revises the draft guidance entitled Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements (issued January 2004). Additionally, this revised draft guidance (Revision 2) has been reissued to incorporate animal prescription drugs; there are no other revisions to the revised draft guidance for industry issued February 9, 2015 (80 FR 6998).