FDA has from time to time seen manufacturers use "bookend" advertisements in print or broadcast formats. These advertisements consist of two parts: (1) a "reminder" advertisement, which includes the name of a drug or device but makes no safety or effectiveness claims; and (2) a disease awareness message encouraging consumers to seek health care practitioner assistance in identifying and treating a particular health condition but does not mention any product by name. Neither component alone would be subject to FDA rules for requiring risk disclosure. But taken together, FDA is concerned that they are understood by consumers as product claim advertisements, without the inclusion of proper disclosure of required risk information.
The draft guidance therefore provides advice to manufacturers on the criteria FDA uses in determining whether bookend advertisements are subject to regulation as product claim advertisements. The criteria, in brief, are whether the two components are perceptually distinct and whether they are separated in space or time. FDA requests comment on these two criteria.
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FDA may treat ads as labeling or advertising: "when the communication is presented in combination with reminder promotion or product claim promotion in a way that causes the audience to perceive the two pieces as one advertisement or promotional labeling piece."
"For example, some drug firms have broadcast help-seeking advertisements in combination with
perceptually similar reminder advertisements, separated only by a brief period containing
unrelated intervening matter. When considered in isolation, the help-seeking advertisement
conveys the message, 'There is help for a particular medical condition; see your doctor,' As
discussed above, this advertisement would be neither labeling nor advertising and thus would not
be subject to the requirements under the act for the disclosure of risk and other information. The
perceptually similar reminder advertisement, by itself, conveys the message, 'This specific
product is available; see your doctor.' As discussed above, this advertisement would be
exempted by regulation from the requirements for disclosure of risk or other information."
"Together, however, these two advertisements communicate information about a treatable disease
or health condition and the name of a product approved for treatment of a disease or health
condition, and effectively constitute an advertisement that communicates a products indication
and efficacy for a certain medical condition without providing risk and other information. If a
disease awareness or help-seeking piece and a reminder advertisement are presented in a manner
that causes their messages to be linked together by the audience, the failure of the combined
communication to include the risk and other information required under the act and FDA
regulations would cause the advertised product to be misbranded."