FDA has posted a revised draft guidance document on its brief summary and adequate directions for use concerning risk information in DTC print ads to reflect “recent social science research.”
Entitled Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs, the new document updates prior agency policy and describes the brief summary requirement.
The document 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.
Instead, it 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print promotional labeling pieces if firms include the appropriate information as outlined in the revised draft guidance,” it says.
The guidance also includes recommendations to standardize information consumers receive in print advertisements and promotional labeling and to make information more understandable.
It covers recommendations for developing a consumer brief summary, clarifies the risk information that should be included in the consumer brief summary and suggests ways to present this information.