How do prescription drug broadcast advertisements differ from print advertisements?
Current regulations specify two requirements that all prescription drug broadcast advertisements must meet. First, broadcast advertisements must include the product’s most important risk-related information in the audio or audio and visual parts of the advertisement. This is sometimes called the major statement. This requirement is not addressed by the guidance. Second, broadcast advertisements must contain either a brief summary of the advertised product’s risk information, or alternatively, make adequate provision for disseminating the product’s approved labeling in connection with the ad. Thus, the regulations for broadcast advertisements recognize broadcast’s inherent limitations by providing an alternative mechanism for meeting the act’s information disclosure requirement.
