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DTC Advertising: Industry Learning To Live With US FDA’s Clear, Conspicuous And Neutral Rule

 
• By Sue Sutter

Sponsors should consider the DTC ad's audio as the major statement about a prescription drug’s side effects and then choose strategically how to display the accompanying text. TV ads are now employing banners and larger text to satisfy the rule’s “dual modality” requirement.

Old TV sets
There's a new approach to advertising drugs on TV thanks to the CCN rule. (Shutterstock)
Key Takeaways
  • Early lessons from implementing the CCN rule governing presentation of the major statement in DTC TV and radio ads include determining how to disclose serious risks in plain language and allowing adequate time for internal review and FDA consultation.
  • The FDA suggested focusing on the audio portion to fulfill the major statement requirement and then deciding how to present the accompanying text.
  • Sponsors also should consider visual distractions in the ad during the major statement audio, which the FDA will closely monitor.

Pharmaceutical companies are learning to navigate the US Food and Drug Administration’s final rule on presentation of the major statement in direct-to-consumer TV ads in a clear, conspicuous and neutral...

Companies should consider the audio in a DTC ad as the major statement about a prescription drug’s side effects and then strategically choose how to display the accompanying text. They...

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