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FDA Document: FDA proposes guidelines for presenting drug risk details in promotional materials
In response to complaints that drugmakers employ various multimedia techniques to downplay risk information in advertising, the FDA released draft guidance for the industry suggesting how to present such details adequately in broadcast and print campaigns targeted at consumers and physicians.
Regarding voice-over presentations of product risks, the advice cautions that "if risk information is considerably more difficult to hear and process than benefit information because it is presented at a much faster pace, the piece will not convey an accurate impression." The FDA guidelines, which are not mandatory, also note that visually busy scenes involving moving camera angles and frequent scene changes "can misleadingly minimise the risks of a product being promoted by detracting from the audience's comprehension." The guidance also states that overall, agency reviewers will take into account "the net impression conveyed by all the elements of a piece," and that companies should focus on "the messages conveyed by the promotional piece as a whole."
Commenting on the draft advice, PhRMA senior vice-president Ken Johnson remarked that member companies have adopted voluntary guidelines calling for risks to be "presented in clear, understandable language without distraction." He noted that drugmakers "remain committed to producing responsible, balanced promotional materials."
Reference Articles
Guidance for industry - Presenting risk information in prescription drug and medical device promotion - (FDA)
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