The FDA's March 2012 guidance clarifies the need for pre-dissemination review of certain direct-to-consumer television ads, categorizing them into six groups and outlining submission procedures. Sponsors must submit a complete review package no later than 45 days before airing their ads and may need to clarify what constitutes 'draft' and 'final' versions to avoid budget and timing issues. It is recommended that brands consult their regulatory teams to ensure compliance with FDA guidelines and potential implications for broadcast media.

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Highlights
FDA Guidance on TV Ad
 FDA clarified the need for pre‐
Pre‐Dissemination Review
By: Leigh Miller, Associate Account Director
dissemination review of DTC March 2012
Television Ads for
sponsors/brands that fall into one Summary
of six categories. The FDA has clarified the need for pre‐dissemination review of
certain DTC Television Ads in the Agency’s March 2012 guidance
 Determine whether this guidance document, which includes the following:
may apply to other broadcast  Descriptions of the types of TV ads that FDA intends to be
subject to this provision
tactics such as online ads and
 Explanation of how FDA will notify sponsors/brands that an ad is
patient testimonials.
subject to the requirement of review
 Descriptions of the procedures sponsors/brands should follow
 Evaluate procedural as well as to submit their TV ads to FDA for pre‐dissemination review
timing and budget implications
for your brand. This document provides RTC’s interpretation of the guidance as
well as implications for broadcast media as a whole.
Key Information
 FDA has grouped TV ads that are subject to pre‐dissemination
into six categories1
 The complete review package should be submitted no later than
45 days before dissemination of any TV ad
 FDA cannot provide final comments on the TV ad without
viewing a final recorded version in its entirety
 If sponsors wish to first submit a review package with a draft
version of the ad, the sponsor will also need to submit the TV ad
in its final form to pre‐dissemination review
 FDA does not expect a sponsor/brand to resubmit its draft TV ad
for pre‐dissemination review if revisions made are in response
to the Agency’s comments and do not introduce any new
information, claims, etc.
 In the event that FDA cannot review within 45 days of receipt of
the complete review package, sponsor should determine
whether it will wait for FDA’s comments before disseminating;
sponsor should notify FDA of its decision
1http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInf
ormation/Guidances/UCM295554.pdf

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While the guidance document refers only to Television advertising, RTC believes that this guidance may
have implications for all broadcast media as brands look for opportunities to maximize the use of
production assets across multiple media options. RTC recommends that these guidelines be discussed
with your regulatory team to ensure that your brand is in alignment with all FDA guidelines.
Implications and Action Items
 It is important for each sponsor to understand whether the brand is subject to pre‐dissemination
review as well as understand under which category the brand may be grouped
 FDA’s definitions for “draft version” and “final version” of the Television Ad for submission
purposes are unclear; there is a potential for significant unforeseen budget increases or lengthy
time implications if definitions are not clarified within your organization
o “Final version” could be defined two ways:
1. “Final” version: post filming, editing, color correction and final mix
2. “Rough cut” version: post filming and editing
o If either version is submitted and receives comments, costs would be incurred:
1. If “Final” version: a) At the very least, need to revert back to “rough cut,” make
changes and then complete the final color correction and mix for a second time; b)
may need to reshoot depending on comments
2. If “Rough Cut” version: May still need to reshoot, but could reduce costs as final mix
and color correction would only need to be completed once
o A “draft version” could also be defined two ways:
1. Storyboard
2. “Rough cut” version (budget implications should be considered as noted above)
o Regardless of how “draft version” is defined, submitting a draft for review will lengthen the
timeline as the final version will need to submit for a second 45 day (or more) review
 RTC recommends working with your regulatory team as well as the FDA to create definitions
for these versions and proactively determine how this will affect your budgets and timelines
 FDA has provided specific review package specifications2 on the Agency’s website; it is important to
review these with your agency partners and determine how this may impact budget and timing
considerations for your broadcast projects
About RTCRM
RTC Relationship Marketing (RTCRM) is a full‐service direct marketing and relationship marketing agency based
in Washington, D.C., in the heart of Georgetown, with an additional office in New York. RTCRM boasts more
than 40 years’ worth of innovative, targeted solutions that grow its clients’ brands and help them forge lasting,
valuable relationships with their customers. What distinguishes RTCRM is its unique ability to analyze data and
research on both a rational and emotional level. RTCRM’s clients include major brands in the telecom,
technology, and pharmaceutical.
To learn more about RTCRM, please visit www.rtcrm.com or follow the Twitter feed @rtcrm.
2
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm090159.htm
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