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Background Music During Risk Segment Of Rx Drug Ads: FDA Explains Its Policy

 
• By Brenda Sandburg

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.

Music background
FDA declines to prohibit use of background music during presentation of risk information in prescription drug ads • Source: Shutterstock

The US Food and Drug Administration waited to respond to Knowledge Ecology International’s 2020 citizen petition requesting a total ban on background music during presentation of risk information in prescription drug advertising until it issued its “major statement” final rule, telling the group that current regulations are sufficient to address problematic ads.

“As a matter of regulatory policy, we believe that the best course of action at this time is to continue the approach in our longstanding regulations that considers all of the elements in each specific ad, to determine whether risk information is communicated effectively, without a total ban on background music or any other particular element,” Center for Drug Evaluation and Research director Patrizia Cavazzoni stated in an undated

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The loss of policy analyst, legal, project manager and social scientist positions has experts wondering if the Trump Administration is eyeing a broader effort to limit DTC advertising. The OPDP layoffs are expected to result in delayed reviews of promotional pieces.

US FDA Cites Taiho’s Lytgobi Healthcare Provider Website For Misleading Efficacy Claims

 
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Ad/Promo: Improved Adherence Claim For Dexcel’s Hemady Not Supported, US FDA Says

 
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Switzerland Simplifies Imports Of Unauthorized Drugs To Tackle Drug Shortages

 
• By Eliza Slawther

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• By Vibha Ravi

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• By Sue Sutter and Derrick Gingery

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