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OPDP Submission of Proposed Direct-to-Consumer (DTC) TV Ads for Advisory Review

What constitutes a complete and reviewable submission?

Proposed DTC TV advertisements submitted for advisory review should include the following information and documents as part of the submission:
  • Cover letter:
    • Subject line that states "Request for Advisory Comments on Proposed DTC TV ad", the NDA/BLA number, Proprietary Name/Established Name (dosage form)”, and the name of the advertisement. 
    • The letter should also indicate whether the Office of Prescription Drug Promotion (OPDP) has previously commented on this ad, the comment date, and the MA#. 
    • Contact name, title, address, phone, fax, and email of the person that OPDP should contact about issues related to the submission. 
  • Generally send 10 paper copies of: 
    • Annotated storyboard, with sequentially numbered frames, to show which references support which claims 
    • Annotated current Approved Package Insert /Medication Guide/Patient Package Insert, all cross-referenced to the storyboard 
    • Annotated references to support product claims not contained in the labeling, cross referenced with the storyboard 
    • Annotated references to Support Disease and Epidemiology Information 
    • Spokesperson verification – i.e., verification that a person who is held out as either being an actual patient or actual doctor is in fact a real patient or real doctor. Verification should consist of a signed statement from the spokesperson certifying that the claims they make in the piece about being a doctor/being a patient and actually prescribing or using the drug are accurate. 
    • Official translation for proposed foreign language DTC television advertisements 
  • For new drugs or indications, or drugs in a class advertised on TV for the first time, please send 17 copies of the items above. 
  • Optionally, submissions for advisory review may include a video or animatic of the proposed advertisement on CD or DVD.  Paper copies of the entire submission must be included even if the submission contains a video or animatic on a CD or DVD. Please submit two copies of such material in one of the following media formats: 
    • MPEG-2-HD (High Definition Video)
    • WMV-HD (High Definition Video) 
Companies planning to send more than one proposed DTC television advertisement to OPDP for advisory review should not consolidate them into one submission. Instead, each proposed DTC television advertisement for advisory review should be submitted separately (not bundled together), and each submission should be complete and reviewable as a stand-alone submission.  A submission should not rely on references or other materials previously provided to FDA or submitted as part of another submission.
 
Please be advised that other promotional material should NOT be bundled together with submissions of proposed DTC TV ads for advisory review (for example, companies should no longer send a print advertisement in a package with a proposed DTC TV advertisement for advisory review).
 
Proposed DTC TV ads for advisory review should be sent directly to FDA’s central document room. 
 
Project Manager
Office of Prescription Drug Promotion
Center for Drug Evaluation and Research
Food and Drug Administration
5901-B Ammendale Road
Beltsville, MD 20705-1266
Attention: DTC TV Ad for Advisory Review
 
OPDP strongly encourages companies to note on the exterior package that the submission is a proposed DTC TV ad for OPDP advisory review. Companies with questions about submission of proposed DTC TV advertisements should contact OPDP at 301-796-1200 and ask to speak to a Project Manager or the relevant reviewer.
 

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Page Last Updated: 10/10/2014
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