FDA Issues Draft Guidance for Industry: Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements

Today, the FDA published the draft guidance for industry entitled “Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements.” The draft guidance describes FDA’s recommendations for presenting quantitative efficacy and risk information in direct-to-consumer (DTC) promotional labeling and advertisements for prescription human drugs and biological products and prescription animal drugs and in DTC promotional labeling for over-the-counter animal drugs. 
This guidance is intended to provide recommendations for how manufacturers that choose to include quantitative efficacy or risk information about their drugs in direct-to-consumer (DTC) promotional materials can make the language and presentation more consumer-friendly.
In addition, we hope that the guidance will encourage industry to consider the recommendations on the following topics: 
• Presenting probability information in terms of absolute frequencies, percentages and relative frequencies 

• Formatting quantitative efficacy or risk information 

• Using visual aids to illustrate quantitative efficacy or risk information

• Providing quantitative efficacy or risk information for the treatment group and the control group