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Rx DRUG AD "OVERPRINTING" OF PROMOTIONAL MESSAGES SHOULD BE DISCONTINUED -- FDA

Executive Summary

Rx drug ads should not carry printed promotional messages over full disclosure statements, FDA's Drug Advertising and Labeling Div. advised in a recently issued policy guide. The ad division said it "has become acutely aware of the overprinting of promotional messages and other information on the full disclosure of prescribing information in promotional labeling materials or the corresponding 'brief summary' in prescription drug advertisements." Noting that overprinting has become a common practice, an agency spokesman cited a recent antibiotic ad by Pfizer in which "penetrability" is written in bold red ink over the prescribing information for the drug. FDAers also note that overprinting has also appeared in ads for Wyeth's Triphasil, Ayerst's Inderide-LA, and Squibb's Capoten. The agency asserted that such "overprinting" of promotional messages in bold letters over prescribing information, "even when done in a fairly inconspicuous manner, detracts from the prescribing information required by regulation and changes the emphasis and meaning of information included therein." Therefore, FDA said, "we are advising that this practice be discontinued." FDA based its decision on the FD&C Act authority to proscribe a practice if the practice: "Fails to present information relating to side effects and contraindications with a prominence and readability reasonably comparable with the presentation of information relating to effectiveness of the drug, taking into account all implementing factors such as typography, layout, contrast, headlines, paragraphing, white space, and any other techniques apt to achieve emphasis.'" FDA's Drug Ad Div. used an informal statement to communicate its policy rather than a regulatory action against the offending ads. The ad division described the policy statement as an "informal communication" that "represents the best judgment of the division" and does not represent the formal position of FDA's Center for Drugs and Biologics.

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