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Fair Balance

Similar or Alternative Terms Meaning the Same Thing Important Safety Information (ISI)
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Definition

In direct-to-consumer advertising, fair balance refers to the presentation of accurate and fair assessment of the risks as well as the benefits of the drug.

"[T]he presentation of true information relating to side effects and contraindications is comparable in depth and detail with the claims for effectiveness or safety."


"The FDA should make clear that the fair balance requirement for DTC ads prohibits only ads that convey a deceptive impression of the risk and benefits from the overall presentation of information, rather than those that fail to achieve a mechanistic balance between risk and benefit information because they do not present such information with identical emphasis."

"Although a mechanical application of the fair balance standard ensures proportionality between benefit and risk information, it could unnecessarily restrict the ability of advertisers to present truthful, non-misleading claims. For example, if a mechanistic approach were adopted, an advertisement might violate the fair balance requirement if it presented benefits clearly and conspicuously in 24-point type and presented risk information clearly and conspicuously in 18- point type. Such an ad may not be “fairly balanced” in terms of format, but it may, nevertheless, effectively communicate both benefit and risk information to consumers. Ads lacking in fair balance thus do not necessarily mislead or otherwise injure consumers.74 On the other hand, an ad might present benefit and risk information in the same size and font, but it would be misleading if it discussed only minor risks without disclosing significant side effects.

"The FTC staff recommends that the FDA clarify that, in interpreting and applying the fair balance requirement, the FDA prohibits only ads that convey a deceptive impression of the risk or benefits of a drug from the overall presentation of information, rather than those that fail to achieve a mechanistic balance between risk and benefit information."

Source: FTC, Response to Request for Public Comment by FDA on Consumer-Directed Promotion.


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