Consider the 'reasonable consumer'

Share this article:
DTC drug and device marketers looking to steer clear of FDA ad reviewers should follow the “reasonable consumer standard” and consider the net impression their promotions make on the lay viewer, not just the particulars, FDA said in a May 26 draft guidance.

Titled “Guidance for Industry: Presenting Risk Information in Prescription Drug and Medical Device Promotion,” the draft guidance, summarized in the Federal Register, said the agency, “like FTC, takes into account the different levels of expertise of lay consumers and healthcare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In evaluating content, the draft guidance said the agency looks for balance in the quantity of risk and benefit information, which should be proportionate to the length of the piece as not to overload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The agency will accept written or electronic comments on the draft guidance submitted through August before finalizing the guidance.
Share this article:
You must be a registered member of MMM to post a comment.
close

Next Article in Features

Email Newsletters

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Features

Read the complete September 2014 Digital Edition

Read the complete September 2014 Digital Edition

Click the above link to access the complete Digital Edition of the August 2014 issue of MM&M, with all text, charts and pictures.

Medical marketing needs mainstream Mad Men

Medical marketing needs mainstream Mad Men

Agencies must generate emotional resonance with the target audience, not unlike Apple, Pepsi or Nike

Are discounts cutting out co-pays?

GSK's decision to cut Advair's price spurred some PBMs to put it back on formulary. Will drugmaker discounts diminish the need for loyalty programs? How can these programs stay relevant beyond giving co-pay assistance?