pre-NOC and post NOC disease state APS
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Hi,
It seems to me the rules to create a PAAB-exempt disease state APS the same as the rules to create a PAAB exempt pre-NOC APS (there is no mention of treatments/healthcare products (by name, class, or category); no drug issues are discussed (e.g. adherence, side effects...); no linkage of any kind to drug therapy; not speaking about a disease mechanism of action to be targeted/alluding to the potentials of changing or modifying this pathway in any way; no speaking to potential targets or stating that not addressing a specific pathway is an unmet need). Is this correct?
Thank you very much in advance for your help.
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Hi,
It seems to me the rules to create a PAAB-exempt disease state APS the same as the rules to create a PAAB exempt pre-NOC APS (there is no mention of treatments/healthcare products (by name, class, or category); no drug issues are discussed (e.g. adherence, side effects...); no linkage of any kind to drug therapy; not speaking about a disease mechanism of action to be targeted/alluding to the potentials of changing or modifying this pathway in any way; no speaking to potential targets or stating that not addressing a specific pathway is an unmet need). Is this correct?
Thank you very much in advance for your help.
Happy Friday @turnapage
In theory, they are very similar. The potential hiccup, is that disease state pieces which do not speak to or allude to treatment/targeting pathways, can be discussed in an exempt disease state piece. However, in a pre-NOC piece, focusing on a disease state pathway for which no treatment currently targets, can easily and inadvertently be constructed in a manner that results in an implicit association to treatments/products. Particularly in the presence of messaging that speaks of a pharmaceutical manufacturer actively performing research in the corresponding therapeutic area. (see also, PAAB Q&A Pre NOC Communications)
Other points of consideration not raised, are the references. If the references in a pre-NOC piece speak to the investigational product, it could be considered indirect promotions of a drug prior to NOC. We also have to consider branding elements. Note that use of visuals/designs prior to NOC which already exist in other jurisdictions in association with the brand would be an indirect promotion of an unapproved product. This would contravene section c.08.002 of the Food and Drug Regulations.
As it is easy for these editorial pieces to result in implicit association to treatment/products, we do suggest that pre-NOC editorial pieces undergo review.
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Happy Friday @turnapage
In theory, they are very similar. The potential hiccup, is that disease state pieces which do not speak to or allude to treatment/targeting pathways, can be discussed in an exempt disease state piece. However, in a pre-NOC piece, focusing on a disease state pathway for which no treatment currently targets, can easily and inadvertently be constructed in a manner that results in an implicit association to treatments/products. Particularly in the presence of messaging that speaks of a pharmaceutical manufacturer actively performing research in the corresponding therapeutic area. (see also, PAAB Q&A Pre NOC Communications)
Other points of consideration not raised, are the references. If the references in a pre-NOC piece speak to the investigational product, it could be considered indirect promotions of a drug prior to NOC. We also have to consider branding elements. Note that use of visuals/designs prior to NOC which already exist in other jurisdictions in association with the brand would be an indirect promotion of an unapproved product. This would contravene section c.08.002 of the Food and Drug Regulations.
As it is easy for these editorial pieces to result in implicit association to treatment/products, we do suggest that pre-NOC editorial pieces undergo review.
@jennifer-carroll thank you for your very helpful response as always!! Just a clarification on the second sentence: I was under the understanding that post-NOC disease state APS that discussed treatments would be reviewed as an editorial under PAAB and additionally you could not allude to a product by discussing mechanism of action (https://forum.paab.ca/search?term=689&in=titlesposts). Is this still correct about post-NOC disease state APS?
Thanks again very much for your time!
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@jennifer-carroll thank you for your very helpful response as always!! Just a clarification on the second sentence: I was under the understanding that post-NOC disease state APS that discussed treatments would be reviewed as an editorial under PAAB and additionally you could not allude to a product by discussing mechanism of action (https://forum.paab.ca/search?term=689&in=titlesposts). Is this still correct about post-NOC disease state APS?
Thanks again very much for your time!
Hey @turnapage
The underlying premise of being exempt is that there is no reference to Health Product Information. This is the premise the previous response was given under.
In contrast, Editorial APS allows for content related to Health Products/drugs, but (among other criteria) there should be no direct/indirect emphasis on the sponsor’s product(s) and it must be balanced and objective. Please refer to Code section 7.5 for details on Editorial APS.
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Hey @turnapage
The underlying premise of being exempt is that there is no reference to Health Product Information. This is the premise the previous response was given under.
In contrast, Editorial APS allows for content related to Health Products/drugs, but (among other criteria) there should be no direct/indirect emphasis on the sponsor’s product(s) and it must be balanced and objective. Please refer to Code section 7.5 for details on Editorial APS.
@jennifer-carroll Thank you for your help
