As per PAAB Code 2.2, the federal drug schedule (e.g. Pr for prescription products) in addition to the brand and generic names of the product must appear in juxtaposition as least once in both the advertising copy and prescribing information.
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As per PAAB Code 2.2, the federal drug schedule (e.g. Pr for prescription products) in addition to the brand and generic names of the product must appear in juxtaposition as least once in both the advertising copy and prescribing information.
Press releases to the public should be nonpromotional and thus, are exempt from PAAB review, and you should avoid conflicting with the federal Direct-to-Consumer advertising regulations. Please refer to the Health Canada guidance document "The Distinction Between Advertising and Other Activities" for the section titled "Press Releases/Press conferences". It is available at http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/actv_promo_vs_info-eng.php It gives criteria when a press release is nonpromotional and therefore not subject to advertising regulations. The company logo would be fine in most cases. The brand logo may be questioned if other elements appear to make the document promotional of a particular drug. Branding is seen as a promotional activity and we would recommend not using the brand logo if the intent is to make a nonpromotional press release.
Pourquoi ce site web: http://cavabiencavamal.ca/index_fr.html n'a pas l'approbation du PAAB. Est-ce que les sites web ne comptent pas comme un médias? De plus, il n'y a pas la mention de qui sponsor le site,ce ne serait-il pas contraire à l'article 6.5.2?
Le CCPP ne répondra pas aux questions spécifiques au produit, l'entreprise ou les individus dans ce forum public. S'il vous plaît appeler notre bureau à 905-509-2275 pour demander à notre Chef Réviseur Patrick Massad de répondre à votre question. Le but de ce forum est de discuter l'application du Code d'agrément de la publicité quant aux problèmes ou scénarios généraux.
Would a card describing the Ontario Drug Reimbursement process (codes, who to contact, etc) for a drug be PAAB exempt?
Example - Title might say "Reimbursement of [drug class] including drugX".
Drug logo (no tagline) included.
Yes, this item would require PAAB review under code section 7.5 i.e. institutional message with product mention. Please note that if you only say "Now on Formulary" and nothing else, it is exempt (s6.6).
As follow-up to Question #91 and as referenced in question and answer #46, if the off-label content of the educational material (publication) is not the focus and will not be discussed by the rep, and that the reps are trained to use the material in a non-promotional manner, would this then comply to PAAB exemption?
You appear to be trying to create a grey area. The issue that you have to address is "Are you 'advertising' your product by the use of this material?". The definition of advertising includes "promote the sale of a product". If you are using the "educational" (no such designation exists in the regulations) material to promote the sale of your product then you are advertising. Health Canada has a guidance that says that if you link advertising and non-advertising materials then all of it becomes advertising. I suggest to stay away from the perception of promoting off-label information. There must be a valid source of information regarding the on label stuff if it found its way into the "educational" material. Many companies are setting policies to not let their sales reps distribute materials that are not intended for promotional use for perception and control reasons.
I have a question regarding minimum font size for safety and balancing copy. It is clear in the PAAB code that it is required to be 75% of the main claim in size. The reasons for this are obvious if one is producing a journal ad or printed piece - the balance copy must be legible.
However, if the APS is a 10 foot high panel, does the same ratio apply? In such a case, the balancing copy is almost beyond legible (too big) and consumes the entire bottom of the panel.
I am not aware of the 75% requirement being in the PAAB code. There is a requirement that advertising be accurate, complete and clear and contain fair balance to not mislead (s2.1) The proportion of 75% is a guideline used by review staff to help advertisers meet that requirement for most APS reviewed at the PAAB. Therefore, for a large exhibit panel we would recommend that the type size be large enough to be legible to a reader from an appropriate standing distance i.e. if they can get close to it to read it easily then it does not have to be 75% of the main body copy. It would depend on the booth size and the panel location.
Terminology is important because "advertising" is federally regulated. Therefore, the material is either "advertising" or "not advertising" for regulatory purpose. There is no such category as "educational" within the terminology of the law If the material has been produced independently and is to be distributed in its entirety without additional comment or editing by the company, it is exempt from PAAB review as per code s6.6. However, because of the context of the distribution (eg: drug rep), this may still be considered to be "advertising" if there is focus on the sponsor's product in the content. As such, we suggest ensuring that there is no off label content in violation of the PAAB Code and federal law. The sales reps should be thoroughly trained on SOP to handle this material in a non-promotional manner. We can provide an opinion if they so choose to submit for opinion. Also see the Health Canada document " The Distinction Between Advertising and Other Activities" for the section on distribution of advertising material related to CME/Symposiums see http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/index-eng.php with reference to the section that speaks about distribution of material after the event.
Does PAAB follow the US Pharma codes requirement that companies can not provide giveaways at promotional conventions as of 2009. However, for a US company that is participating in a canadian international convention that is currently licensed in the US for a particular product or use but not licensed in Canada, are giveaways at the booth appropriate, and if so what kind of giveaways are appropriate?
This is not within the PAAB mandate or scope. PAAB Code section 2.8 covers giveaways mentioned in advertising and this is not the case in your question. The Rx&D Code of Conduct sections 7a and 11 cover distribution of gifts and service-oriented items and the PAAB encourages all companies to follow that code when marketing health care products in Canada. See http://www.canadapharma.org/. Also see the Health Canada document " The Distinction Between Advertising and Other Activities" for the section on distribution of advertising material at international conferences see http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/index-eng.php.
This would be a promotional meeting and the meeting itself is not subject to PAAB review. However, if the pharma company sponsor provides slides to the speakers or materials to the meeting health professional attendees, they would be an Advertising/Promotional system (APS) subject to PAAB review. Prescribing information (could be a product monograph or a package insert) should be available at the meeting.
Yes
Jennifer Carroll
Senior Reviewer Communications
Pharmaceutical Advertising