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If a reprint carrier is being produced, can the content be based on the paper even if some of the points to be made are not part of the product monograph? For example, if data pertaining to subgroup and multivariate analyses were not included in the product monograph but are discussed in the article, can they, i.e., subgroup and multivariate analysis, be part of the text highlighted on the reprint carrier?
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View Answer [+]
According to section 3.1 of the PAAB Code claims in advertising, including reprint carriers, should be consistent with the Health Canada approved product monograph and labeling. The PAAB would not approve distribution of a clinical reprint that focuses on off label claims. It may be acceptable to distribute the reprint as a whole if the off label claims are not the primary focus of the study. That is variable and subject to review for a definitive statement on specific cases. However, the off label claims should not be highlighted on the reprint carrier. The PAAB has had intervention by Health Canada regarding subgroup analysis claims that have appeared in advertising and did not appear in the product monograph. We would suggest submitting the data to Health Canada as part of an SNDS.
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Can a pharmaceutical company distribute a third party piece (a textbook) via their representatives? It is a textbook that they are providing sponsorship for only and thus is exempt from PAAB rules (Section 6.6a).
Does this book require a reference section with the product monograph in it as the product is discussed within the content of the textbook?
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View Answer [+]
Yes, pharmaceutical companies can distribute textbooks via their representatives. With respect to how it fits into the PAAB Code s6.6.a, it depends on what "sponsorship" means. If the book was published independently and not commissioned by the pharma company, it would be considered to be third party. According to Health Canada guidelines in the "Distinction Between Advertising and Other Activities" independently published textbooks would not be considered advertising when distributed by pharma companies. That means the company had no involvement in the production of the textbook. If the textbook content was balanced and objective and did not appear to promote the sale of a product, it would not be considered 'advertising'. If the textbook content focused mainly on the sponsor's products, it could be considered 'advertising' when distributed. If the pharma company was involved in the production or selection of the writers and it mentioned healthcare products, it could be consider ed 'editorial advertising' with respect to section 7.8 of the PAAB Code of Advertising Acceptance.
It is a good idea to show the references for any scientific publication. Whether the book is not 'advertising' or if it is 'editorial advertising' subject to PAAB review, the product monographs of the products mentioned in it does not have to be shown as part of it. If the book was focused on the sponsor's products it could be considered to be 'product advertising' and therefore the prescribing information requirements of section 7 in the PAAB Code would apply.
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Are there specific APS guidelines for corporate booth panels? Is it possible to create a panel/poster that just lists the product and its indication and not provide full product balance (i.e. adverse events and contraindications)? Full product balance/PI would be available at the same corporate booth.
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View Answer [+]
There are no specific PAAB guidelines for corporate booth panels. Health Canada has a guideline for what is advertising in Exhibit Booths in their policy document "The Distinction Between Advertising and Other Activities".Advertising in corporate booth panels is subject to PAAB review. In this case, you can do an institutional ad and list the products and therapeutic class with respect to PAAB Code section 7.7 that reads:
7.7 Institutional Advertising/Promotion Systems (APS)
These are designed to create and maintain a favorable image of a company, its products and its services. See exemption [6.6 (e)].
These systems may be used at any time at the discretion of the advertiser but must be submitted for PAAB review and acceptance prior to publication. They must not contain therapeutic or other claims of product merit or status. They may contain:
(a) A general statement about the pharmaceutical company, its products and its service(s) and policies.
(b) A partial or complete list or illustration of products manufactured and/or distributed by the company, along with their respective therapeutic [11.4] or pharmacologic [11.5] classifications.
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Could a brand name be placed on a plastic portfolio that would contain a reprint carrier.
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View Answer [+]
The PAAB reviews the APS as a whole and we advise that they check with Rx&D regarding the plastic portfolio since they have ruled against similar vehicles.
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ACME Pharma ha 20% of the share in Rx's in its class and has been gained about 5% share over the previous year.
NEWGUY Pharma has a 2% share, up from 1% the previous year. Can NEWGUY claim "fastest-growing" product within its class by virtue of a 100% growth? Even though ACME experienced only a 20%, twenty percent of a million is a lot more 100% of 20,000.
How would PAAB rule NEWGUY's claim of "fastest-growing" or "largest annual growth"?
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View Answer [+]
The PAAB would reject the claims. For "Fastest growing" claims, there must be a minimum growth of at least 5% (absolute) over all other products in the same category during each of the last 6 consecutive and the product must have been on the market for at least one year. See the "Supplementary PAAB Guideline for the Review of Market Share Claims in Advertising".
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What does "well-controlled and/or well-designed" in s. 3.1.1 mean?
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View Answer [+]
We generally ask for double-blind, randomized trials as reference support for advertising claims. They should be controlled by either placebo or an active comparator, and should be statistically analyzed. In the case of active comparators, it is important to note that the drugs must be compared under the same conditions of use (s. 5.2).
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If we put a BRC regarding a patient program regarding our product in the product package, do we have to send the patient program for PAAB review?
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View Answer [+]
You should check with Health Canada regarding "labeling" requirements when you add information to the product package or inside the package. Some companies choose to send these BRC's to Health Canada as labeling. If Health Canada accepts them, they are exempt from PAAB review. If not, it would usually be a promotional item subject to PAAB review. You can check with us. Remember federal labeling requirements apply to sample packaging. This would usually fall under Code s6.4.
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I was curious, to your knowledge , how many companies are currently operating within the PAAB meeting report exemption , either legitimately or otherwise . I know if anybody has this information it would be likely yourself. I am curious and was hoping you could shed some light on this issue
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View Answer [+]
There is no meeting report exemption. The PAAB did away with that supplementary guideline on April 1. PAAB Code section 6.6.a was rewritten and it allows an exemption from review for reports that are not advertising by the PAAB definition in Code s11.1 i.e. it is unbiased information not about the sponsor's products. Anything with some emphasis on the sponsor's products distributed to a broad audience in an unsolicited manner is "advertising" by the Food & Drugs Act definition of advertising and the PAAB Code definition. The content and relation to the sponsor are the key elements, not who the publisher is. Thus, if a company commissions a report about a study related to their product, it is most probably "advertising".
