FDA issues revised Draft Guidance for Industry on Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs
FDA has announced the availability of a revised draft guidance for industry, “Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs.” This revised draft guidance updates prior FDA policy and describes the Agency’s current thinking about the brief summary requirement for consumer-directed print prescription drug advertisements. These updates incorporate information from social science research undertaken since the issuance of the last draft guidance.
The revised draft guidance includes recommendations to standardize the information consumers receive in print prescription drug product advertisements and promotional labeling and to make information more understandable to consumers. It provides recommendations for developing a consumer brief summary,clarifies the risk information that should be included in the consumer brief summary and provides additional guidance regarding ways to present this information. (Note that this revised draft guidance does not focus on the presentation of risk information in the main body of promotional labeling or advertisements.)
Additionally, this revised draft guidance recommends that firms not disseminate the full FDA-approved package insert (PI) to fulfill the adequate directions for use requirement for consumer-directed print promotional labeling for prescription drugs. Rather, the revised draft guidance recommends that firms provide the same content and format used in the consumer brief summary in lieu of the PI. Therefore, the FDA does not intend to object if firms do not include the entire PI with consumer-directed print promotional labeling pieces if firms include the appropriate information as outlined in the revised draft guidance.
Because this current revised draft guidance contains new recommendations, the FDA is reissuing it as a revised draft to seek public comment. The FDA is also withdrawing the draft guidance for industry entitled “Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements.”
The Small Business and Industry Assistance program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance and information to regulated domestic and international small pharmaceutical business and industry through its website, email notifications, and workshops. This notification system provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical business, which includes Federal Register notices, guidances, workshop announcements, etc. This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM - 4:30PM.