The FDA has released a final guidance on how companies should present quantitative information about the risks and effectiveness of drugs in direct-to-consumer advertising. The guidance, which is meant to make drug advertising more consumer-friendly, includes recommendations on presenting efficacy and risk information using words, numbers, or visual aids. The FDA also advises using absolute frequencies or percentages rather than relative frequencies, and contextualizing relative frequencies using corresponding absolute probability measures. The guidance recommends using the same numerical format throughout a promotional piece or advertisement, using denominators in multiples of 10, and expressing probabilities using whole numbers. Visual aids such as graphs, tables, and icon arrays are also recommended to help illustrate and contextualize information. The FDA’s draft guidance received relatively few comments from the industry, and the final guidance is similar to the draft version. However, there is one major addition related to the presentation of information about control groups in studies. The guidance now states that companies should provide quantitative information from both the treatment group and the control group when applicable. This change aims to improve consumers’ ability to evaluate a drug’s benefits and risks and make informed decisions. Another key change in the final guidance is that firms should present the absolute probability measure prominently and in direct conjunction with the relative frequency measure. The guidance also eliminates a sentence stating that the recommendations apply to promotional materials regardless of the medium, indicating that the FDA recognizes certain communication mediums may require different approaches. Overall, the final guidance provides important recommendations for companies to consider when presenting quantitative information about drugs in direct-to-consumer advertising.
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