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  • 1.  Linking a Journal Article on a Company's Social Media Post

    Posted 25-Jan-2024 13:55

    Hello, can someone clarify if posting a link to a published article discussing disease state education would be considered promotion? Would it be best practice to have the said journal article reviewed by PRC prior to approving the social media post? Thank you!



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    Heather Baker
    Newark TX
    United States
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  • 2.  RE: Linking a Journal Article on a Company's Social Media Post

    Posted 26-Jan-2024 04:04

    Hello Heather,

    I think it depends on what the published article is speaking about and how it may be perceived.  Though my thoughts in general is it could be perceived as promotion especially if the results of the published article were too "unbiased" considering the disease state or the objectives of the study.  Definitely it should be vetted internally to determine if it would be appropriate to link on a company social media site and providing internal support for doing this action.



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
    Oriel STAT A MATRIX - ENTERPRISE
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    Original Message


  • 3.  RE: Linking a Journal Article on a Company's Social Media Post

    This message was posted by a user wishing to remain anonymous
    Posted 29-Jan-2024 09:32
    This message was posted by a user wishing to remain anonymous

    Yes, I believe it is promotion. There were some untitled letters from FDA maybe 5+ years ago in which even a like was considered promotion. It also goes back to the "what you link to becomes yours" concept. You should have the journal article reviewed. 


    Original Message


  • 4.  RE: Linking a Journal Article on a Company's Social Media Post

    Posted 30-Jan-2024 08:53
    Edited by Kevin Stark 30-Jan-2024 08:54

    Yes, I would consider this promotion and require PRC review as it links to branded content. I consider all brand and disease information that relates to products as being regulated and therefore PRC review would be important. 

    It looks like it does not mention brand so does not require FDA submission on form 2253, but still promotion.



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    Kevin Stark, RAC
    Global Head, Advertising, Promotion and Labeling
    Mallinckrodt Pharmaceuticals
    440 US Route 22 East | Suite 302 | Bridgewater, NJ 08807 | USA
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    Original Message


  • 5.  RE: Linking a Journal Article on a Company's Social Media Post

    Posted 30-Jan-2024 12:29

    Yes, putting a link on your website is considered promotion. Via a "one click rule" you are considered to be making all the claims in that article. You should review the article via your normal review process to make sure all claims are consistent with your labeling and any regulatory limitations (say for PMA devices or prescriptions drugs)

    Ginger



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    Ginger Glaser RAC
    Chief Technology Officer (contract)
    MN
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    Original Message


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