The FDA is recommending that drug companies aim for comprehension with their consumer-directed print ads by limiting the risk information, more fully integrating it via text and visual cues, and by using more consumer-friendly language.
According to the guidance document, an FDA survey showed that consumers currently don’t read the brief summary in direct-to-consumer (DTC) print drug ads, with the majority of people describing it as difficult to read. It’s worth noting that for DTC print ads, manufacturers use a format for prescription drugs that contains the entire risk-related section of the package insert (PI) in order to satisfy the regulator’s previous requirements – this is known as the traditional approach.
Not only is the PI – whose target audience is healthcare providers – often composed of lengthy lists of all possible adverse events, it’s also written in technical medical terminology that doesn’t resonate all consumers. For these reasons, the FDA believes the traditional approach isn’t ideal for these types of ads, and is proposing alternative methods.
The guidance calls for a brief summary focused on the most vital risk information instead of one that includes the entire list of risks. Further, the information should be presented in a way that lends itself to consumer understanding, thus helping patients “make informed decisions about the medication being promoted.”
The agency is strongly recommending that companies use consumer-friendly language in all consumer-directed print material. The language in the consumer brief summary should be designed for comprehension by a broad target audience with varying literacy skill levels.
In addition, the guidance states that the information should be “presented in a readable format,” recommending that drugmakers carry over elements from the ad creative, such as logos and branded colors; use easily readable font sizes and style; and avoid plain block paragraphs, instead opting for the use of spacing and indentations.