Revised FDA Draft Guidance for consumer-directed promotional Rx drug labeling

The US Food and Drug administration has released revised draft guidance for industry, “Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling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This revised draft guidance updates prior FDA policy and describes the agency’s current thinking about the brief summary requirement for consumer-directed print prescription drug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 These updates incorporate information from social science research undertaken since the issuance of the last draft guidance.

The revised draft guidance includes recommendations to standardize the information consumers receive in print prescription drug product advertisements and promotional labeling and to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 (Note that this revised draft guidance does not focus on the presentation of risk information in the main body of promotional labeling or advertisements.)