Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

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

Executive Summary

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.

You may also be interested in...



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

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.

Bill Would Make US FDA Issue Final Rule On Risk Information In Broadcast DTC Ads

Proposed rule issued in March 2010 requires ‘major statement’ on a drug’s side effects in ‘a clear, conspicuous, and neutral manner’ for TV and radio ads. Bill would mandate a final rule within six months.

DTC Ads: Citizen Petition Pushes For Narrow But Strict Music Ban

KEI argues a wholesale ban on music during the presentation of risk information in drug ads would be a more clear-cut way for FDA to enforce its existing goals. Others say the ban goes much further than past FDA policy and enforcement.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS149411

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel