Non-product branded APS, pre-NOC teasers
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The responses, guidance, and advisories provided by the Pharmaceutical Advertising Advisory Board (PAAB),
including but not limited to those available through the PAAB Forum, the PAAB website, and any PAAB
correspondences, are specifically intended to assist individuals navigating the PAAB preclearance system.
Repurposing or reproducing this content without written consent from the PAAB Commissioner is strictly
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311 - If a disease state can cause mortality, but products in that class are not indicated to improve survival/ reduce mortality (they are indicated to treat the disease), can mortality be discussed in a disease context if the same piece also discusses therapy options (editorial piece), or in the case of a branded piece a specific product? Would their be a need to completely separate the discussion of mortality in a disease-only piece that would have to be discussed in a separate call from any branded messing or discussion of therapy?
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238 - Hi PAAB: Educational material on disease state is being put together in an APS for doctors to distribute to appropriate patients, after the doctor has educated the patient on the disease state. The doctor will provide the handouts to the patients at his/her discretion. Is inclusion of a branded section on how to use the product allowable for this APS?
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235 - Dear PAAB: We have both unbranded and branded APS approved by PAAB. What are suggested and appropriate mechanisms for unbranded (HCP:patient teaching tools) and branded APS to be distributed by sales representatives, so as to not create linkage between the pieces? Are separate calls (branded and unbranded) appropriate? Is distribution of the unbranded APS (i.e. by request form, business reply card etc.) with follow-up by the sales representative specifically to discuss the unbranded APS, an acceptable way to separate the pieces?
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40 - At a recent medical conference there was a company display that promoted a disease specific message. There was no product mention and the posters did not go to PAAB, although the imformation clearly introduces a specific message. As per question and answer #39, this would seem to be within guidelines, assuming there was no other promotional material at the booth. The complicating factor is that this company does not have an approved product for the disease state being presented. There is a great deal of discussion and "noise" surrounding their product and when it will be available but, to date, it has not receieved NoC. Is this within guidelines? It appears to be promotion for a product currently undergoing review?
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