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If you are creating a Pt Booklet based on Part III of the Product Monograph, can you also include a patient-friendly description of the primary efficacy outcome? If so, how about primary and secondary efficacy outcomes?
Product content is limited to that which appears in part III of the PM. Unless the study endpoints are discussed in part III (which is unlikely), you cannot discuss the study outcomes in the patient piece (even in patient friendly language). PAAB s6.4.3.
Does PAAB let us place information in detail aids that is in a reference found in a PM but not in the PM text itself?
Mention of a study in the PM bibliography has no influence on the PAAB review. PAAB code section 3.1.2 states that citation in the bibliography section of the Product Monograph does not indicate proof of acceptance by Health Canada. For consideration in advertising, a reference must meet the PAAB code requirements relating to the desired claim regardless of whether that reference appears in the PM bibliography or not.
I am interested in PAAB training. How can I achieve this training?
Contact Reviewer/Trainer Jennifer Carroll by calling the PAAB office (905-509-2275).
If a pharma company is developing a brochure that includes general information about clinical research to better educate patients who might be considering participation in a clinical trial, is PAAB (or another regulatory body) required to review and approve the brochure? Please note that this resource would not be developed for use during a specific trial; it is strictly for general patient education purposes.
Patient information directed to patients through the physician would be reviewed under PAAB code s6.4.3. I am assuming that although the piece is general (i.e. not referring or alluding to a particular medication), information about clinical trials for drug therapy would be discussed (even if only on a concept level).
If you meant ‘general public’ rather than ‘patient’ then review from an advertising preclearance body would not be required. Nonetheless, you are free to use the PAAB consultative opinion service at your discretion (see www.paab.ca for fee schedule).
It sounds as though the piece is not intended to be a clinical trial recruitment piece. If it were, you’d also want to take a look at the section “Clinical Trial Recruitment” in the Health Canada policy document “The Distinction Between Advertising and Other Activities”.
I am curious to know how/why the product ColdFX can make DTC claims such as 'clinically proven' and '#1 doctor recommended'. Would this not fall under the NHP regulations of PAAB?
Thanks for your question. There is an important distinction to make here with regards to the Canadian regulatory landscape for drug advertising. The PAAB code applies to health care product advertising which is directed to healthcare professionals. Natural Health Products (NHPs) are indeed included in the PAAB code’s definition of health care products (PAAB s1 & 11); however, DTC for NHPs falls neither within the scope of the PAAB code nor within the scope of PAAB review activities. As a courtesy, concerns relating to NHP DTC advertising may be directed to Advertising Standards Canada, MIJO, or Health Canada.
The scope of the PAAB includes promotional healthcare product communication for prescription, non-prescription, biological and natural health products to health care professionals in all media.
PAAB also provides advisory comments on direct-to-consumer materials for prescription drugs.
You can learn more about the PAAB vision, mission, mandate, and scope at the following link: https://www.paab.ca/about.htm
Would a corporate message similar to "Company X is committed to research in prostate cancer" be PAAB exempt?
On its own (not linked to anything else), this statement is a corporate message without product mention. It is therefore exempt under s6.6(v). Please keep in mind that Health Canada is very concerned about pre-NOC product messages (whether direct or implied). If you plan on including additional information, it is advisable to submit the piece for PAAB review with the aim of avoiding inadvertently creating materials that contravene C.08.002 of the Food and Drug Regulations.
Are notes to HCPs allowed to be attached to PAAB material or approved studies. If not, where is this referenced in the code.
PAAB approved ads should be used exactly as approved otherwise it’s not really “preclearance” (e.g. without modification through inclusion of additional notes affixed to the piece). Affixing notes to independently generated materials could cause them not to be exempt. It is a best practice to have clear internal regulations either prohibiting use of notes in this manner or explaining the limited cases in which such notes can be used (e.g. best to restrict this to administrative notes like “sorry I missed you” and/or contact info).
Do STI cards (cards that patients use to obtain medications for free or as a copay) come under PAAB or is this another industry organization that handles how these are used.
It’s the content on the card (or auxiliary pieces) that cause a piece to be exempt rather than the specific media. If the card only has the drug name, it is exempt per PAAB code s6.6. Images on the card could cause it not to be exempt. Also, linking the card to other content (which is typically the case) could cause the card to be non-exempt (e.g. if the linked materials exceeds PAAB code 6.6. for exemption).
I would appreciate clarification of the Explanatory Note for 6.6 that says "Now on provincial formulary" (or equivalent). Does "or equivalent" allow you to mention a new strength and still be exempt? (e.g. The product is already on formulary but the product came out with an additional strength that was just added to the formulary and it is that new strength of Product X that is being announced as "Now on Provincial Formulary". Thank you!
The claim “Drug X 15mg [i.e. the strength] is now on [provincial] formulary” is exempt.
I am a journalist doing a story on what advertising and or perqs are allowed to be given to doctors and medical professionals to use/prescribe a drug. What regulations are in place governing what is aimed at the medical professional?
Hi. I am responding in Patrick’s absence. The PAAB website has a wealth of information regarding regulations and guidelines that govern health product advertising to health professionals, consumers and patients. See also the Rx&D code of ethical conduct and Health Canada information on their website. If you have specific questions please call the PAAB office and ask to speak to Ray Chepesiuk.
Jennifer Carroll
Senior Reviewer Communications
Pharmaceutical Advertising
