Rx Drug TV Ads Must Present ‘Major Statement’ Simultaneously In Audio & Visual Segments
Executive Summary
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.
You may also be interested in...
Background Music During Risk Segment Of Rx Drug Ads: FDA Explains Its Policy
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.
US FDA’s ‘Incremental Step’ On Rx Ads: A Long Time Coming
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.
DTC Proposed Rule Leaves Room For Creativity In Meeting Standards
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.