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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.

The long-awaited rule, to be published in the 21 November Federal Register, has a few changes from the proposed rule issued in 2010. It adds the terms “consumer friendly” and “terminology” to the requirement that the major statement be presented in a way that is readily understandable

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