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When advertisers work with the PAAB for a pre-clearance approval what do they receive in terms of official approval?
Once all PAAB comments have been addressed an approval letter is provided. The approval letter includes an approval code which specifies the 1 year approval period for the advertisement. During the indicated approval period, the advertiser has permission to use the PAAB logo on the approved APS.
Can we provide marketing items such as pencils, cups or post-it with braded name only of future prescription drug currently under NOC review (not approved yet in Canada) but FDA approved. Distribution would be to general Canadian public and health care practionners during Canadian conventions.
The Food and Drug Regulations prohibits the advertising of drugs prior to NOC (C.02.008), so the distribution of branded gifts or product branded advertising (i.e. coupons) prior to receiving approval from Health Canada would appear to contravene Federal Law. With respect to gifts and giveaway items, you should refer to your trade organization’s code of ethics. For example, The Innovative Medicines Canada Code of Ethical Practices covers the distribution of gifts and we encourage all companies to follow that code when marketing health care products in Canada.
Can we provide a link from our disease state page on our local website to our global disease state page containing information about the same topic? If a disclaimer pops up prior to the user leaving the Canadian website and viewing content on that disease state global page, are we able to do this?
To answer this question, there are a few important details which would need to be considered. Who is the intended regulatory audience, are the sites gated, is the disease information on a product branded site (i.e. are we creating a link between branded and unbranded content). For example, if we assume that the question relates to linking disease information on a product branded HCP gated site to disease information on the global corporate site, the answer is ‘no’. Per section 6.5.4 of the PAAB code, you may link to a corporate global site only by linking to the homepage.
An important exception to the ability to link to the global (or local) corporate website homepage follows: based on direction from Health Canada the product branded pre-gate portion of a prescription drug website must not contain a hyperlink to a corporate website containing product monographs. The link between the two may exceed the restrictions set out in Section C.01.044 of the Food & Drug Regulations.
On an HCP gated website that provides branded drug information, is it mandatory that the very first page after the gate is cleared be the "safety information" for that drug? Assuming the "safety information" link is accessible from the main navigation menu, can the landing page after the gate be some other content? Thanks.
When assessing safety information or fair balance requirements, particular care is required for tools like websites as it is difficult to predict the path in which the information will be consumed. Additionally, the entire content is not typically consumed in one sitting. The simplest way to ensure physicians are exposed to the required fair balance copy is to include it on the brand product homepage. Linking middle level to highest level of fair balance on the homepage is an option which may help address space issues. Inclusion of a “Safety Information” menu item on every screen cannot replace the fair balance requirements described above. Please refer to the guidance document “Guidance on Base Fair Balance Level Selection and Placement” for more information.
Can you use "New" in APS for a product that has been on the market but has had their indication revised/expanded?
Terms related to or suggesting “new” should be restricted to one year post marketing (Code section 11). If there is a change to the terms or market authorization that changes the products scope, it can be used for one year post the change, however, the copy should be clearly limited to the feature that is new (i.e. “new data”, “new indication in population X”). As an example, addition of an indication in pediatrics, should be clearly limited to this population, not a broad and open statement of “new”. Similarly, a revision to the indication which creates a greater restriction on the use of the product, should not be positioned as a “new” indication, but as a new restriction on use.
In the indication for a product has been updated (ie. expanded), can you put a "New" sticker on the front page of the Product Monograph for distribution to HCPs?
The product monograph is the Terms of Market Authorization approved by Health Canada. The document itself should not be modified outside of the regulatory process described on the Health Canada website (regarding the processes for each level of change).
What you can do is generate a promotional monograph. Promotional monographs should not be labeled as “Product Monograph”; they should be identified as advertising/ promotional systems (APS) with titles similar to “Promotional Monograph”, “Marketing Monograph”, or “Clinical Monograph” and reviewed to approval by the PAAB. Please see Guidance on Promotional Monographs document on the PAAB website (http://www.paab.ca/advisories-guidance.htm) for more information.
Note that “new” is a broad and unclear statement. What is new? Is it the product? Is it an indication? Is it a dosage form? Etc… During the PAAB review process, PAAB will ensure your promotional monograph is aligned with the PAAB code.
We have a patient survey conducted by a patient association looking at reasons for stopping therapy. Can we use this information in an unbranded APS to highlight the most common reasons for stopping therapy?
For the use described in your question, the surveys would either need to be published in a peer reviewed journal, or it would need to be designed, conducted & analyzed without sponsor’s influence (s5.10.2). The messaging would be limited to aspects which are non-clinical (so as not to require a clinical trial as evidentiary support) and you’ll need to remove messaging deemed to be disparaging to a product or product class/category. CAVEAT: This is a very general answer to a general question. There are MANY factors which could impact whether a survey is acceptable as evidentiary support. In my experience, things have gone more smoothly when clients first submitted the survey (or at least a thorough description) in a written opinion request (see our fee schedule) along with the types of messages they wished to convey. Sometimes the issue is the reference, but often the issue is the underlying message.
Can a company have a corporate pre-launch journal ad that speaks to an unmet need/care gap for a disease state that they don't yet have a product?
As per Ask PAAB question 99, you can speak to the disease and to some degree "patient's unmet needs" but not if it is disparaging to current therapy or points at a specific alternative.
A company is entering into a new disease state in which they don't already market a product in Canada.If they produce a corporate ad (pre NOC) indicating that they are now entering into the therapeutic area/disease state, can they mention the therapeutic area/disease state in the ad?
In the context of a corporate message, a company can discuss the areas in which it is doing research regardless of whether it has an approved product for that condition. There are regulatory provisions you need to be aware of when creating such pieces. For example, as per C.08.002 of the Food and Drug Regulations, advertising must not allude to products which have not yet been approved for use in Canada. The PAAB preclearance system will help you discuss the therapeutic area in a manner which is consistent with the regulations. As a general comment, a message that “Company X is doing research in condition Y” would enable you to accomplish your stated goal.
1. Can a modified intent-to-treat (mITT) analysis be used in promotional materials? mITT analysis excluded patients who discontinued due to adverse event, lost to follow-up, or subject withdrawal. 2. If yes, would also need to show the primary endpoint analysis, ITT, as shown in the PM? 3. Are there any specific requirements on how the primary ITT and mITT analyses need to be displayed?
Claims supported by a superiority trial should be based on ITT. This means that all patients who were enrolled & randomly allocated to treatment are included in the analysis and are analysed in the groups to which they were randomized.
Note that mITT, by definition, is a deviation from ITT. It should not be used as the basis/evidence for a claim.
Patrick Massad
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