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Rx Drug TV Ads Must Present ‘Major Statement’ Simultaneously In Audio & Visual Segments

 
• By Brenda Sandburg

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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FDA final rule on the presentation of an Rx drug's risks in TV and radio ads includes additional fifth standard. • Source: Shutterstock

The US Food and Drug Administration’s final rule on the presentation of the “major statement” about a prescription drug’s side effects and contraindications in direct-to-consumer television and radio ads includes an additional standard than that in the proposed rule, requiring that the statement be presented simultaneously in audio and visual portions of the ad.

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