Regulatory Open Forum

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  • 1.  Advertising and Promotion

    This message was posted by a user wishing to remain anonymous
    Posted 18-Feb-2021 13:59
    This message was posted by a user wishing to remain anonymous

    I am interested in the latest thinking on ads intended for Connected TV (e.g. Hulu).  Does anyone have feedback on whether it's distinct enough from broadcast TV to go without preclearance or would you recommend treating it like broadcast TV?



  • 2.  RE: Advertising and Promotion

    Posted 18-Feb-2021 16:42
    Personally I would treat it identically to TV adds.  These services have become rather ubiquitous during the pandemic and it is likely that the FDA would look at this as an ad that has at least reasonable potential to meet the DTC definition so I would send it through pre-clearance up front rather than having to explain why I didn't when FDA comes calling asking questions about it.

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    Victor Mencarelli
    Global Director Regulatory Affairs
    MelvilleNY
    United States
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    Original Message


  • 3.  RE: Advertising and Promotion

    Posted 19-Feb-2021 03:50
    Hello,

    Agree with Victor as would treat any media/social media/media outlet as an advertising source.  If there is any Direct To Consumer outlet, these should go through the same rigour as any other advertising or marketing review.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 4.  RE: Advertising and Promotion

    Posted 19-Feb-2021 07:47
    While I won't disagree with the advice posted so far, I will highlight that the only guidance on this topic is that "broadcast" DTC ads are covered under the PhRMA DTC Guidelines that members have committed to submitting for FDA Advisory Review.  FDA has not come out and made any kind of determination that all of these new "channels" that are "like" broadcast, but not under that old school definition.  FDA certainly welcomes and encourages pre-submission, but there is no requirement to do so in this case.

    My experience has been that the decision to submit for FDA Advisory review (in the non-PhRMA covered scenario) is one that varies greatly across industry.  I believe you can definitely and safely NOT submit and be fine, but if so you should be sure you have designed the content just like broadcast ad recommendations.  That decision to submit for review is based on many factors:  company risk tolerance, project timelines and budget, impact that potential comments from FDA will have on your entire promotional campaign as they will expect you to pull through comments across all of your promotional materials, etc.

    Glenn Byrd

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    Glenn Byrd, MBA
    President, GByrd Ad-Promo Solutions, LLC
    President, RAPS Board of Directors
    United States
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    Original Message


  • 5.  RE: Advertising and Promotion

    Posted 19-Feb-2021 08:03
    Edited by Alicia Whittlesey 19-Feb-2021 08:07
    We just recently worked with a client through promotional review committee to submit an ad for a client that was for mediums such as Hulu to the FDA for comment and also received very helpful comments back in a short period of time. After doing some research and consulting with regulatory colleagues, it was decided that the guidance was interpreted to include these types of ads and the FDA was receptive.

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    Alicia Whittlesey
    Counsel and Director of Compliance Services at Porzio Bromberg & Newman P.C.
    Westborough MA
    United States
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    Original Message


  • 6.  RE: Advertising and Promotion

    Posted 19-Feb-2021 08:51
    If you are thinking of a drug ad then suggest you contact the Office of Prescription Drug Promotion.

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    Robert Schiff PhD, RAC, CQA, FRAPS
    CEO
    Schiff & Company, Inc.
    583 Mountain Avenue
    North Caldwell, NJ 07006
    rschiff13@aol.com
    973-568-3361
    ------------------------------

    Original Message


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