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  • 1.  US Ad Promo and EUA vaccines- fair balance?

    This message was posted by a user wishing to remain anonymous
    Posted 24-Jan-2022 13:56
    This message was posted by a user wishing to remain anonymous

    As a regulatory specialist I am curious how ads on TV and the radio promoting the EUA COVID vaccines in the US are allowed, given the drug laws on advertising and promotion of drugs.  What I have seen and heard have no disclaimers-such as only being offered under emergency use, potential side-effects, consult your doctor, etc. The ads even go so far as to state that getting a vaccine will make you safe and protect your life, although no specific brand is mentioned.
    Can anyone give me their thoughts on how these ads get around the legal requirements of drug promotion in the US?


  • 2.  RE: US Ad Promo and EUA vaccines- fair balance?

    Posted 24-Jan-2022 16:20
    Hi Anon.

    My guess is simple - the ads are not being aired by or on behalf of the manufacturers of the vaccines.  They are being aired (at least here in my area) by either the city or state health departments or medical societies and they are fairly broad claims around helping to mitigate negative impact from COVID infections.  Because no company is technically benefiting from the ad and because the typical statements at least here seem to be towards the idea of protection and imploring the population to become vaccinated or to receive their boosters or in some instances more recently about the new authorization for different age groups, it is likely something that FDA is not going to go after.

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    Victor Mencarelli
    Global Director Regulatory Affairs
    MelvilleNY
    United States
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    Original Message


  • 3.  RE: US Ad Promo and EUA vaccines- fair balance?

    This message was posted by a user wishing to remain anonymous
    Posted 25-Jan-2022 10:44
    This message was posted by a user wishing to remain anonymous

    I agree with Victor that some ads would be outside FDA's purview because they are not being produced by a pharmaceutical manufacturer.

    With that said, I have heard ads on the radio that do they they are from one of the vaccine manufacturers. I'll have to listen to those ads carefully, but I don't recall any disclaimers.

    Another aspect to consider is that FDA's promo police seems more interested in risk information being conveyed accurately vs benefits. In the case of this vaccine, there seems to be a big agreement on its benefit with minimal risks, so that may not be necessary.
    Original Message


  • 4.  RE: US Ad Promo and EUA vaccines- fair balance?

    Posted 25-Jan-2022 09:49
    I actually haven't seen any ads by the manufacturers for these. Lots of PSAs by health departments etc, but no "ads" in the advertising and promotion sense of the guidelines.

    In general, Drs, hospitals (and probably by proxy public health departments) can make all sorts of claims about products that the manufacturers can't - look at all the things about LapBand, LASIK, robotic surgery etc. Sometimes if there turns out to be a demonstrated risk, FDA will crack down on this, but it usually takes years.

    Ginger

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    Ginger Glaser RAC
    Chief Technology Officer
    MN
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    Original Message


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