Claims & Support/References for Claims
239
Topics
391
Posts
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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430 - One of the pivotal trials for an advertised brand has a reference comparator (RC) arm (i.e., the trial has statistical analysis for the advertised brand vs placebo and the RC vs placebo, but no statistical analysis for the advertised brand vs RC). The Product Monograph mentions the RC as part of the design, but no RC data is included in the PM. Can the data for the RC vs placebo be shown in an APS?
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423 - Definitions Section 1.8 of the PAAB code states: Use of the word 'new' or statements implying "new" in advertising should be restricted to 1 year after initial marketing. Can you please clarify what is meant by "initial marketing"? Is this the NOC date or when "marketing" activity is initiated etc.?
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404 - Hi Patrick, I am doing a slide kit for the reps based on our PM. In the PM it mentions a study with our drug against a non-approved drug, so I can use this info in my slide. New studies have come out on our drug vs the non-approved drug would I be able to use this new data in my slide deck for the reps.
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385 - Our client would like to produce a Canadian consensus statement in a disease area where there are currently no relevant guidelines. The publication would be peer-reviewed and cover all therapeutic options; we would ensure that any discussion of the sponsor's product was on-label. The intent would then be to distribute reprints through the sales force, and possibly also create an unbranded APS highlighting the availability of the consensus statement (no emphasis on a particular drug). Can you give us any guidance on how we should set up the consensus process and paper to be acceptable for these uses? Assuming the publication is peer-reviewed, would the fact that it has a single sponsor be an issue? Is endorsement by a medical association required or just recommended? Thanks in advance.
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384 - What type of references are allowed in unbranded materials? I am interested in using studies which are based on patient surveys/questionnaires as well as some review papers (neither of which have a focus on the company's branded product). Would these type of references be allowed or are strictly limited to the same rules as branded communications? Thanks.
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383 - We have 2 questions regarding inclusion of treatment guideline statements that address drug place in therapy (our product is sited by non-proprietary name) in HCP-directed APS: 1. a) Can treatment guideline statements be included anywhere among product claims? b) Similarly, can treatment guidelines be included on the other side (back or front) of a page containing product claims? 2) Can treatment guidelines be included on the other side of a page containing the main sections of the Product Monograph of product sited in the guidelines (Dosage, Indications, Warnings and Precautions, Contraindications and Adverse reactions)?
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364 - Hello, Can text from Part III/Consumer Information of a PM be used as a reference within and HCP directed piece? For example, if we were to define patient types that a product is indicated for and use the language defining such patients from Part III, would this be acceptable in HCP directed materials?
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