New Draft Guidance on Presentation of Risk Information in Promotion: A Study in Summarizing DDMAC Letters

By Dara Katcher Levy & Roger C. Thies –

For the past several years, industry has relied on Warning and Untitled Letters to determine DDMAC’s  “current” thinking on the presentation of risk information in various promotional pieces. 

On May 26, 2009, FDA issued a draft Guidance for Industry: Presenting Risk Information in Prescription Drug and Medical Device Promotion.  The Draft Guidance largely sums up the “minimization of risk” issues cited in those DDMAC Warning and Untitled Letters with few surprises.  Of note, the Agency states that it will apply the “reasonable consumer standard” to prescription drug and medical device promotion as it does for dietary supplements and food.  While noting that presentation of risk information should be crafted to reflect the audience, FDA also reiterates that the same standards on presentation of risk information apply to both healthcare professional and direct-to-consumer promotion.  Although the content may differ, FDA defines its principles as “universal concepts of communication and understanding of risk information.”  To support its positions about appropriate content and format of risk information, FDA cites to articles that FDA states reflect “well-developed social science principles supported by decades of scientific research.” 

The Draft Guidance gives little credit to physicians – their training and ethical obligations and responsibilities – in analyzing physician understanding of information presented in product promotion.  The Draft Guidance notes that physicians are influenced by product advertising and are “subject to the same cognitive biases and processing limitations as non-experts.”  Later in the Draft Guidance, FDA states that one of the serious effects of missing certain risk information in a direct-to-consumer advertisement is that “it may cause consumers to fail to inform their healthcare professionals of important considerations, and healthcare professionals to prescribe inappropriately or even dangerously.”  Clearly, FDA does not contemplate physicians making informed, medically appropriate decisions when prescribing product that may also be the subject of promotion.

The Draft Guidance does not answer the “big” questions with regard to the most rapidly evolving area of product promotion – the Internet.  Although FDA includes “internet web sites” as “promotional material” that is covered by the Draft Guidance, FDA has not addressed the unique challenges posed by product information included on the Internet (font size and screen shot variations by computer, individual webpages on a larger website, hyperlinks to content not controlled by the product’s manufacturer, etc.,). 

Although much of the Draft Guidance is known to those who follow DDMAC letters, it is “must” reading.  It brings to one document DDMAC’s approach to labeling and advertising review.  The 20 examples of flawed approaches to presenting risk information, while simplistic, aptly demonstrate DDMAC’s concerns and should help industry with its promotional copy review activities.