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I realize that ads with only name, price, and/or quantity are considered exempt. If I was to compare the price of Drug X to Drug Y, and have a statement that said "Drug X offers a __% savings vs Drug Y", would this be considered promotional and render it non-exempt?
PAAB code section 6.6iv addresses what is considered exempt. It states that “company price lists containing no therapeutic claims, price comparisons or claims of company or product merit, status or issues” are exempt. As a claim of “offers savings vs a competitor” would be viewed as a price comparison, this message would not be exempt.
As follow-up to Questions 291/328/500, would medical device (class II)-sponsored advertising be subject to PAAB review, if comparisons were made between the medical device and a non-medical (drug-containing) device?
It is our understanding that you wish to compare features of a drug-delivery system for a class II medical device and a drug-delivery system which is not classified as a medical device. The latter cannot be presented as a stand-alone device, but must be presented in the context of the drug & device. Although it may be possible to make non-therapeutic comparisons of the device features, the content is subject to the PAAB code provisions.
Exactly when does a 'consumer' become a 'patient' -- is it the point at which they receive a prescription for a specific brand, or when they are dispensed a specific brand? In certain therapeutic categories (eg., epinephrine, insulin), patients receive a prescription for the molecule, which can be associated with multiple brands. At this point before a specific brand is selected, is it permissible for an HCP to expose the 'consumer/patient' to branded material, in order to facilitate brand selection? This scenario assumes that all brand options would contain the identical active molecule.
A patient is someone who has been instructed to take a healthcare product (e.g. someone prescribed a product) or someone for whom the HCP is considering providing such instruction and deems it appropriate to provide information about the product. It is the role of healthcare professionals to distribute health and treatment related information to patients. Given a scenario where multiple brand products contain the same active ingredient, it is at the HCPs discretion to provide the patient with information about a specific brand. As the manufacturer, you are simply providing the HCP with patient information which they may or may not choose to distribute to the patient. The key point here is that the HCP is making the decision for which brand product they are recommending. HCPs should not be instructed by manufacturers to provide information about drug X to patients on drug Y. However, the HCPs may choose to do so unprompted (that’s just medical practice).
If we are developing a postcard with a link to a patient education website on it (website will go through ASC approval) that is designed for the sales rep to give to an HCP to give to their patients, will PAAB have to review the entire website who's link is on the card? The website will have nothing brand specific, it will display all treatment options for patients, however it will have the company logo on it. Thanks!
Patient information, whether branded or unbranded, which is provided via the healthcare professional is subject to the PAAB code (See PAAB code section 1.1). The postcard is intended to be distributed to patients by the HCP and therefore requires PAAB preclearance. PAAB requires that websites controlled/influenced by drug manufacturers included in APS containing the PAAB logo undergo preclearance by an agency recognized by Health Canada for providing advisory opinions relating to DTCI Rx (i.e. PAAB or ASC). The website content in this case has been reviewed by ASC for adherence to provisions relating to consumer information. There is generally no need for PAAB to re-review consumer information because patients are being directed to it. However, the PAAB will require to review the linkage between the postcard and the website. As such, the website will need to be provided to PAAB as part of the postcard review.
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.
Patrick Massad
Commissaire adjoint
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