Consider the 'reasonable consumer,' says FDA draft guidance
Titled “Guidance for Industry: Presenting Risk Information in Prescription Drug and Medical Device Promotion,” the draft guidance, summarized in the Federal Register, said the agency, “like FTC, takes into account the different levels of expertise of lay consumers and healthcare professionals.” Therefore, while statements on the risks and benefits of an advertised product may be perfectly accurate, the ad could be violative if skewed to emphasize benefits and downplay or obscure dangers.
In general, the agency said it considers: consistent use of language appropriate for the target audience; use of signals such as headlines and subheads in print ads and placement or superscript in broadcast ads to emphasize or play down information; framing of risk information using vague or specific terms; and the hierarchy of risk info presentation. Serious risks, the agency said, should be discussed towards the beginning of a section in a print ad and either at the beginning or end of a section in a broadcast ad, lest it be lost on readers or viewers.
In evaluating content, the draft guidance said the agency looks for balance in the quantity of risk and benefit information, which should be proportionate to the length of the piece as not to overload consumers and evenhanded in terms of the complexity with which risks and benefits are described. In addition to the factual accuracy and comprehensiveness of risk info, the agency is also concerned with its location in the ad, the legibility of font size, style and contrast between text and background, even the use of white space to highlight and thus privilege some sections over others.
The agency will accept written or electronic comments on the draft guidance submitted over the next 90 days before finalizing the guidance.