Ask PAAB

Is it possible to produce a teaser ad for a product? Does this ad need to be disease oriented "Something new in X disease area coming soon" or can a brand name be attached to it such as "Brand X coming soon"? Lastly, does this require PAAB review? Thanks you for your guidance.

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  The claim “Brand X is coming soon” can only be employed once the product is authorized for sale in Canada. This ad requires PAAB review. Although PAAB code 6.6 has an exemption for the claim “Now available”, this message is different from “coming soon”. Also note that this message is not accepted prior to product authorization as it promotes an unapproved product.

  The claim “Something new in X disease area is coming soon” would not be accepted as it points to a new product from the sponsor and thus indirectly promotes a product. Teaser ads prior to product authorization should be limited to messaging similar to “Company XYZ is committed to research in disease ABC”.

I am wondering if we are able to create stickers for our material to indicate that we have formulary however I would like to keep it simple and say something like "Now on formulary (special authorization) in your province" or "...in this province" without specifying the province itself. We would of course only place these stickers on tools where the province has received formulary and we would of course provide PAAB with an FYI as to what tools and where we would be placing the stickers. Is this doable?

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  For all provinces other than Quebec, you can generate a sticker with this proposed statement. The sticker would require PAAB review. In the context of that review, we can assess the sticker placement.

  RAMQ (i.e. for Quebec) you’ll need to include the coverage criteria (assume that there are such criteria). There will also be other requirements unique to the Quebec as conveyed in this link: http://www.paab.ca/Advisory_regarding_use_of_RAMQ_in_APS.pdf

We would like to ask PAAB regarding the interchangeability of the term “starter pack” used to identify a traditional sample pack. Certain products have starter packs specifically designed to initiate patients on treatment and help avoid dosing errors and contain patient educational materials. Our question is whether it is possible to refer to a simple sample pack as a “starter pack” when it is not specifically designed as a starter pack and is not mentioned in the TMA?

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  This would not contradict the PAAB code specifically. We advise that you check with your regulatory department to ensure that this would not contravene any Health Canada labelling regulations or contradict any Health Canada naming conventions.

Good morning, Can we disclose the name of the company behind an unbranded website, when such is being asked in a specific tweet? Thanks in advance

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  If any part of the campaign is help-seeking, the company may not be identified to the general public. If you receive a completely unsolicited request for disclosure of the company name from an individual, the request for identification of the company name may be granted in such a way that it is only visible to that particular individual (i.e. not visible to other users). i.e. this is only a response to an “unsolicited request” if the response is only provided to the individual who’s asking the question. This assumes that the individual has not been prompted in some way to ask the question.

Section 3(1) of the Food/Drugs Act implies DTC-A is prohibited for products treating Schedule A diseases. Yet, there seems to be many approved DTC-A campaigns for STDs, Arthritis, etc. How is Section 3(1) being implemented in PAAB practice?

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  PAAB DTCA reviews are a based on the Food & Drugs Act, the Food & Drug Regulations and the applicable Health Canada guidance documents. The PAAB would therefore question healthcare product advertising open to the general public which indicates that the product is for the treatment of a schedule A disease. Note that there are some nuances here which may explain what you’ve seen. For example:

  • Not everything generated by pharma is advertising (i.e. don’t assume that all pharma generated DTC is necessarily DTCA). For example, pharma tools meeting the provisions for “Consumer Brochures” and “Help-seeking announcements” in the Health Canada policy document “The Distinction Between Advertising and Other Activities” are not subject to the advertising regulations. Such tools would be DTCI (i.e. direct to consumer information). Those tools may be about schedule A diseases. The policy document can be found at the following link: http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/actv_promo_vs_info-eng.php
  • Non-prescription products can be advertised to the public (DTCA) for the prevention of schedule A diseases (assuming this is consistent with their Terms of Market Authorization).
  • Some DTC materials have not been reviewed by any of the preclearance bodies and may contravene the regulations (e.g. treatment of Schedule A diseases promoted to consumers). When coming across such advertising, it may be appropriate to launch a complaint. Per the Health Canada guidance document “Health Canada and Advertising Preclearance Agencies’ Roles Related to Health Product Advertising”, you can forward complaints related to DTCA of prescription drugs and Schedule D drugs (biologics, including vaccines) to the Regulatory Advertising and Risk Communications Section of MHPD. You can forward complaints related to DTCA of other healthcare products to Advertising Standards Canada (ASC) or Extreme Reach.

Can you please clarify why product MOA can only come from the TMA, and not published, peer-reviewed in vitro studies? MOA is frequently characterized post-NOC, particularly for products where ‘the exact mechanism of action is unknown’.

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  The qualitative description of a product’s action in advertising must be consistent with its current Terms of Market Authorization in order to satisfy PAAB code section 3.1. Therefore, if the MOA info in the TMA is outdated (e.g. because the MOA is no longer unknown), the TMA is required to be updated in order to include that info in drug advertising.

What is the status of advertising of Schedule II drugs (non-Pr but behind the counter) to the general public? Beyond name, price, quantity?

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  It is the Federal Schedules (not the provincial schedules) that determine the advertising regulations. The restriction you referred to (i.e. name price quantity) applies specifically to products on the Federal schedule “Prescription”. But please note that, as stated in several Q&A responses, even non-prescription products may not be promoted to consumers as treatments for schedule A diseases.

How long does PAAB approval on DTC last? 1 year or 2 years?

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  PAAB provides a “no objection number” rather than an approval per se for DTC. This reflects that we are doing a consultative review based on the Health Canada guidances and Act/regulations. The no objection number expires after a 1 year period.

I am wondering how or if section 103.2 of the Natural Health Product Regulations factors in to the review of NHPs as it appears to exempt some NHPs from part of section 3(1) of the Food and Drug Act.

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  Here are the regulatory provisions which are included in the questions.

  Section 3.1 of the FDA: No person shall advertise any food, drug, cosmetic or device to the general public as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical states referred to in Schedule A.

  103.2 of the NHPR: A natural health product is exempt from subsection 3(1) of the Act with respect to its advertisement to the general public as a preventative, but not as a treatment or cure, for any of the diseases, disorders or abnormal physical states referred to in Schedule A to the Act. Section 103.2 of the NHPR is an enabling provision which sets an exception to the relevant section of the overarching Food and Drugs Act. So yes indeed, a natural product can be promoted to the general public as a preventative for a schedule A disease (provided this is consistent with it’s Health Canada approved Terms of Market Authorization).

  Note that the PAAB provides advisory opinions on DTC for prescription, schedule D, and ethical drugs. PAAB does not provide advisory opinions for DTC advertising about NHPs.

If exacerbation rates are provided in a publication with other details with which NNTs can be calculated, would PAAB allow us to promote the NNTs?

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  The NNT is the estimated average number of patients who need to be treated to prevent one additional bad outcome (e.g. death, hospitalization). An NNT which is calculated by the manufacturer may be included in the APS provided the published paper conveys a statistically significant improvement in the corresponding absolute risk reduction (with multiplicity adjustments performed when required to manage risk of type I error).

  The number needed to treat is the mathematical inverse of the absolute risk reduction (i.e. 1 divided by the absolute risk reduction). Note that the absolute risk reduction is the control event rate minus the experimental event rate.