US regulators have published new draft guidance on direct-to-consumer (DTC) print advertising for pharmaceutical companies and their agencies.
The FDA wants the industry to take a more consumer-friendly approach to the terminology it uses in its print advertising.
It is hoped that by ensuring pharma advertising move away from more technical language consumers will be more aware of a drug’s purpose and the potential risks that come with it.
The FDA conducted 11 studies on drug advertising to develop the ‘Disclosing risk information in consumer-directed print advertisements and promotional labelling for human prescription drugs’ guidance.
There the agency notes: “Research has demonstrated that people process only a limited amount of information at one time both in general communications and in direct-to-consumer prescription drug advertising specifically.”
To make drug information more consumer-friendly, the FDA has recommended companies use terms such as ‘drowsiness’ over ‘somnolence’, for example, and write out only “clinically significant information on the most serious and the most common risks associated with the product”.
The FDA’s revised draft guidance does not clearly address exactly which warnings and precautions should be included on products and, so far, it’s only applicable to print advertising and does not reference other forms, such as television.
It is, however, notable that the FDA has back tracked on its previous guidance stance when it comes to prescribing information (PI).
Now the regulator says: “FDA strongly recommends against the use of the traditional approach to fulfil the brief summary requirement in consumer-directed advertisements, an approach in which risk-related sections of the PI are presented verbatim, often in small font.”
Health literacy remains an issue in the country and in 2006 the US Department of Education published the only national data so far on skills in the area. This showed that, while the majority of adults (53%) had intermediate health literacy, 22% had only basic health literacy skills and 14% had below basic health literacy.