Yesterday, the FDA issued the first revision of the Guidance titled Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements (here).  This Guidance covers the following four topics: 

  • Providing quantitative efficacy or risk information for the control group, when applicable; 
  • Presenting probability information in terms of absolute frequencies, percentages, and relative frequencies; 
  • Formatting quantitative efficacy or risk information; and 
  • Using visual aids to illustrate quantitative efficacy or risk information. 

Following the points above can give consumers qualitative information that is more relevant and makes the data easier to understand.  For instance, when talking about side effects, terms like “rare,” “frequent,” or “most” don’t really tell the story.  However, saying something a bit more concrete, such as that 45% of patients experienced the event, provides a more quantitative perspective of the frequency that patients might encounter the event.  It is also suggested that the quantification of an event for patients as well as those in control groups should be expressed in the ad or promotional piece. 

Likewise, when presenting probability data, the FDA suggests that absolute values (such as that 60 out of 100 patients (60% of patients) had the event or experienced improvement of a symptom) more clearly articulate the intended meaning of this type of data for consumers.  The Agency believes that presenting probability or relative frequency of events may be difficult for many patients to comprehend, and it has some good suggestions, like the one above, for making the data more consumer friendly.  The guidance also has three tips on the formatting of quantitative efficacy or risk information. 

The Agency also discusses how the use of “visual aids such as graphs, tables, and icon arrays are often used to illustrate the information and put the numerical values in context.”  The use of these aids helps consumers and patients better grasp the numerical data presented, and better informs the intended purpose of the data.  There are also a number of tips and examples for firms to consider in the development of promotional materials and labeling pieces addressing these important issues. 

So, you regulatory folks – lend support to your sales and marketing people to be sure that they understand and comply with the FDA’s expectations for these aspects of direct-to-consumer promotional and advertising materials.