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  • 1.  Promotional website - link to news article

    This message was posted by a user wishing to remain anonymous
    Posted 05-Jan-2022 15:33
    This message was posted by a user wishing to remain anonymous

    Hi all,

    I have limited experience in promotional labeling and advertising, and I am reviewing a website for promotional materials.
    The company would like to link a news article from a third-party website (not sponsored by the company in any way) that contains a patient testimonial with a few buzzwords in the title and text. The title has the potential to be considered "misleading" for the drug.

    I couldn't find information on regulations and guidances on referencing a third-party website. If we were to provide a link for this patient testimonial on our website, would we also be responsible for benefit-risk information presented on the third-party website?

    If you could share your thoughts, I would greatly appreciate it. Thank you for taking your time!


  • 2.  RE: Promotional website - link to news article

    Posted 05-Jan-2022 21:40
    Hi Anon

    The short answer is yes, the company bears some responsibility for any information it chooses to share.

    The specific rules vary from one country to another. If this website is intended for US customers, you can review an assortment of guidance from FDA and FTC here:
    https://www.fda.gov/animal-veterinary/guidance-industry/advertising-and-promotion-guidances
    https://www.ftc.gov/sites/default/files/attachments/press-releases/ftc-publishes-final-guides-governing-endorsements-testimonials/091005revisedendorsementguides.pdf

    It won't be as specific as you might hope for, though, since there are so many possibilities. You can also learn a lot by reading through warning letters on the general subject, where you'll find opinions related to specific cases, helping to define the boundaries a little bit.

    ------------------------------
    Anne LeBlanc
    United States
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    Original Message


  • 3.  RE: Promotional website - link to news article

    Posted 10-Jan-2022 08:03
    Hi Anon,

    if you refer to an external source on your official website, you need to make sure that there are no misleading or off-label promotions - this also means that you need to monitor the source of this to make sure that no changes are being made. This refers to various requirements of different regulations (e.g. a little bit hidden in Art. 7 of the MDR). Such a situation can be seen as "official" promotion although the information is hosted on another website. This should avoid that companies "outsource" the promotion, thereby having the opportunity to promote more than allowed.

    However, I have seen multiple instances where a pop-up window is shown as soon as you click on an external link telling that the contents of the linked webpage is not representing "official" information and out of the control of the manufacturer. However, in this case you cannot use the external info in a sense of "look here for all the beautiful aspects of our product".

    Hope that helps - All the Best

    Markus

    ------------------------------
    Markus Lantermann
    Head of Q&R Region International
    Mannheim
    Germany
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    Original Message


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