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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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.
Agency says it will be flexible in assessing if risk information in consumer-focused ads are "clear, conspicuous and neutral," but proposed rule also seeks comment on whether such information should be presented simultaneously in audio and video format.