Slides (Updated 9/13/13)
Slides (Updated 9/13/13)
Slides (Updated 9/13/13)
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Presenting Risk Information:<br />
Advertising-Specific Legal Authorities<br />
§ 21 CFR 202.1(e)(5) – discusses when brief summary unsatisfactory<br />
§<br />
Lacks fair balance between risk/efficacy information such that efficacy information is presented<br />
in “greater scope, depth, or detail”; however, brief summary is met when risk information is<br />
“comparable in depth and detail” to efficacy/safety information<br />
§ 21 CFR 202.1(e)(6) – discusses when an advertisement lacks fair balance<br />
§<br />
Represents/suggests drug is safer or has less side effects/contraindications than demonstrated by<br />
substantial evidence, including by way of comparison to another drug or presentation of studies<br />
showing no or minimal side effects compared to approved label<br />
§ 21 CFR 202.1(e)(7) – discusses when an advertisement may lack fair balance<br />
§ Fails to provide sufficient emphasis on side effects and contraindications<br />
§<br />
§<br />
Fails to present side effects and contraindications with prominence and readability reasonably<br />
comparable to efficacy information, taking into account typography, layout, contrast, headlines,<br />
paragraphing, white space, and any other techniques apt to achieve emphasis.<br />
Fails to provide adequate emphasis (e.g., by the use of color scheme, borders, headlines, or copy<br />
that extends across the gutter) for the fact that two facing pages are part of the same<br />
advertisement when one page contains risk information<br />
6
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