FDA Policy/General

DTC Efficacy and Risk Information Guidance

David McFarland

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FDA has published a guidance, Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements, with recommendations for presenting the cited information in promotional labeling and ads for prescription human drug and biological products, prescription animal drugs, and in DTC promotional labeling for over-the-counter animal drugs. The document says it outlines agency recommendations for how firms that include quantitative efficacy or risk information in DTC promotional communications can make the language and presentation more consumer-friendly. The guidance covers:

  • 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.

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