Rx Drug TV Ads Must Present ‘Major Statement’ Simultaneously In Audio & Visual Segments
FDA’s final rule on the major statement in DTC ads includes additional standard for presenting a drug’s side effects and contraindications in a clear, conspicuous and neutral manner. Rule permits ‘creative elements’ during presentation, including upbeat music.
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Untitled letter says advertisement could lead breast cancer patients to believe Kisqali has better overall survival and quality of life than was demonstrated. FDA also criticizes length of time to read claims in superimposed text and competing audio and visual presentations in the TV spot.
Total ban on background music is unnecessary, agency says in denying KEI’s petition. FDA points to new ‘major statement’ rule and its previous letters objecting to a sponsor’s use of music in ads and says it will continue case by case analysis of ‘all of the elements’ in an ad.
Final rule on the so-called ‘major statement’ in direct-to-consumer broadcast ads comes 15 years after the law it is implementing. A lot has changed in the advertising world since then – but FDA says the principles of ‘clear, conspicuous and neutral’ presentation of risk information still apply.