133 - Can a non-gated medical journal web site, whose online advertising is restricted to reminder ads and non-pharma ads, offer unrestricted access to a complete digital version of back issues of the journal (Rx advertising would appear as it does in print)?
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The Rx drug advertising on a non-specialized medical journal may appear on a non-gated website if the Rx drug advertising does not go beyond the name/price/quantity restriction relating to consumer advertising of prescription drugs (i.e. Section C.01.004 of the Food & Drug Regulations). Ensure that this is also the case for back-issues unless they will be gated. The appearance of name-only ads in a specialty medical journal (e.g. Journal of Psychiatry, Journal of Urology...) conveys the message that the drugs are for a condition relating to that specialty. Those ads would therefore exceed the aforementioned C.01.004 restrictions. Also note that "reminder ads" can mean different things in different contexts. In the PAAB code for example, a reminder ad would contain the product's indication. A "reminder ad" of this nature should not be accessible to the general public as this would also exceed the aforementioned C.01.004 restrictions (regardless of the type of journal). This is different from the way in which the term "reminder ad" is used in a DTC context (i.e. name/price/quantity).
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The Rx drug advertising on a non-specialized medical journal may appear on a non-gated website if the Rx drug advertising does not go beyond the name/price/quantity restriction relating to consumer advertising of prescription drugs (i.e. Section C.01.004 of the Food & Drug Regulations). Ensure that this is also the case for back-issues unless they will be gated. The appearance of name-only ads in a specialty medical journal (e.g. Journal of Psychiatry, Journal of Urology...) conveys the message that the drugs are for a condition relating to that specialty. Those ads would therefore exceed the aforementioned C.01.004 restrictions. Also note that "reminder ads" can mean different things in different contexts. In the PAAB code for example, a reminder ad would contain the product's indication. A "reminder ad" of this nature should not be accessible to the general public as this would also exceed the aforementioned C.01.004 restrictions (regardless of the type of journal). This is different from the way in which the term "reminder ad" is used in a DTC context (i.e. name/price/quantity).
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@jennifer-carroll Hi Jennifer, does a reminder ad with indication statement running in a specialty pub require anything more if the drug has a black box warning? Only brand colours and logo would be used, no creative/visuals.
Hello @danielle
Firstly, I apologize for the delay in response as I was on vacation. We’ll look to modify internal processes for the future.
An HCP reminder ad in a gated space, limited to the indication, brand colors and logo with no creative/visuals, would prompt the inclusion of the lowest level fair balance regardless of the black box warning. There are no additional requirements for lowest level fair balance for products with black box warnings.
Be careful, as the question above is about DTC. As noted in the response, “reminder ads” in the DTC space are limited to “name, price, quantity” (no reminder ads are permitted for controlled products). If the ad is going to appear in an ungated space, it should not contain the indication or allude to therapeutic use.
