safety or effectiveness. These exemptions may be less important, however, in the face of new voluntary PhRMA guidelines that limit the use of such items as pens, pads and the like in pharmaceutical promotion. The Concept of Fair Balance The concept of fair balance applies to an entire advertisement or promotional piece. Information on risks (side effects and any other safety issues) and on benefits (efficacy—the beneficial result of an intervention) are required to be comparable in depth and detail. Fair balance is a qualitative, subjective criterion, not a quantitative one. Furthermore, it exists in addition to the requirement of full disclosure. Fair balance means that the content of any communication must be presented in a format that does not distort the balance of risk and benefit information. Information relating to side effects and contraindications must be presented with a prominence and readability reasonably comparable to the information relating to the effectiveness of the drug. Such an interpretation takes into account factors such as typography, layout, color contrast, headlines, paragraphing, white space, and any other visual techniques used to achieve emphasis. In evaluating a drug advertisement or promotional piece for fair balance, the overall impression of the material is most important. The material must present a true, factual representation of the drug in both artwork and copy. Product labeling sets the tone and supplies the facts for the content of an ad or promotion piece, as well as the features for fair balance. Further guidance can be found in the Federal Register of May 27, 2009, which contains FDA's Draft Guidance: Presenting Risk Information in Prescription Drugs and Medical Device Promotion.
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