The Concept of Full Disclosure Prescription drug promotion or promotional labeling materials (eg, detailing materials, direct mail, product videos, etc) are generally required to contain full or complete prescribing information as is found in a package insert. Disclosure requirements for print and broadcast advertising to both professional and consumer audiences are handled somewhat differently as noted previously. Brief Summary: With only a few exceptions, including reminder advertisements, a "brief summary" is required for every print advertisement for a prescription drug. The Code stipulates that the brief summary contain information on all side effects, warnings, precautions, contraindications, and effectiveness. A special exception is made for broadcast advertising (eg, radio, television, and telecommunications, including the Internet), which must include information on major side effects and contraindications—known as the major statement—in the audio or audio and visual parts of the presentation. Unless a package insert will be provided to an audience viewing or hearing the commercial, for example at a conference, the advertiser must also provide a brief summary in the context of the commercial. This is covered further in the discussion on DTC broadcast advertisements on page 61. Reminder Promotion: Reminder ads or reminder promotional labeling are exempt from the brief summary or package insert requirements. The FDA recognizes the limitations of space and time for brand reminders on certain kinds of promotional materials and does not require full disclosure or brief summaries—provided that certain specific criteria for such media are met. Basically, such communications can only call attention to the name of the product and provide no representation or implication about its use,
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