In a bid to give consumers better and more actionable information, the regulator revised recommendations for disclosing risk information in DTC prescription drug ads and promotional labeling in print media as it relates to the brief summary requirement and the requirement that adequate directions for use be included with promotional labeling.

Consumer-directed print ads often include the complete risk-related sections of the PI — also known as the “traditional approach” —to satisfy the brief summary requirement, and generally use the full PI to meet the adequate directions for use requirement.

Because many consumers lack the technical background to comprehend some of the information contained in the PI, the FDA doesn’t believe these approaches are ideal. Further, some of the information included may be of limited use to consumers. The FDA says the brief summary should be focused on the most important risk information without including an “exhaustive” list, and the information should be presented in a way that consumers will likely comprehend. The FDA also notes the sheer volume of material included in the PI, along with the format and technical language, could make it more difficult for consumers to understand the information.

The agency is thus issuing guidance explaining an alternative disclosure approach referred to as the “consumer brief summary.” This alternative approach to developing content can satisfy both the brief summary requirement for DTC print ads as well as the promotional labeling requirements, according to the guidance document.

In going over options for disclosing risk information, the FDA recommends that companies use consumer-friendly language in consumer-directed material. The consumer brief summary should contain language designed for comprehension by a broad target audience with various levels of literacy skills, and technical language, scientific terms and medical jargon shouldn’t be included. The guidance notes that a conversational tone or language meant to engage the reader may be useful, citing examples like using “drowsiness” rather than “somnolence,” or “fainting” rather than “syncope.”

The FDA also specifies that the consumer brief summary needs to be presented in a “readable format,” pointing to deadlines and subheadings as examples for communicating important information. Logos and brand colors can also help readers understand, and font size and style should be chosen with readability in mind. The FDA also recommends the use of double spacing and indentations rather than plain block paragraphs, among other things.

With regard to content, the document calls for the inclusion of clinically significant information on the most serious and common risks associated with the product, and the omission of less pertinent information. In going over the content, the FDA points to several reference points for selecting risk information, and notes the types of information the consumer brief summary should include and which information it should omit. In addition, if the risk information in the consumer briefing summary isn’t comprehensive, the FDA calls for the inclusion of a statement reminding consumers that the information included isn’t comprehensive, or advising them to talk to their healthcare provider, call a provided number or visit a website for product labeling.

The document also covers format, recommending a prescription drug facts box or a Q&A format. The FDA says with the former, information can be presented within a box similar to the OTC Drug Facts box, with standardized headings like “uses,” “do not use if you” or “warnings,” for example. With a Q&A format, the information can appear in columns or a similar layout, with headings framed in the form of questions, such as “What is this drug for?” and “What are the side effects?”