FDA issues draft guidance for industry: Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements - Drug Information Update

FDA issues draft guidance for industry: Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements - Drug Information Update

FDA published the draft guidance for industry entitled “Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements.” The draft guidance describes FDA’s recommendations for presenting quantitative effectiveness and risk information (information that numerically addresses the likelihood or magnitude of a drug’s effectiveness or risks) 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 describes how manufacturers can make quantitative effectiveness and risk information in direct-to-consumer (DTC) promotional materials more consumer-friendly. The agency hopes 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 effectiveness or risk information Using visual aids to illustrate quantitative effectiveness or risk information Providing quantitative effectiveness or risk information for the treatment group and the control group