AskPaab

Is it possible to make a “#1 reccommended” brand claim? If so, what support would be required?

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For non-prescription products, we have considered the claim based on robustly designed surveys published in healthcare professional journals. We have not accepted the claim for prescription products. For prescription products, the answer is no. Claims relating to recommendations should emanate from Canadian consensus guidelines (i.e. these inform the extent to which a product is recommended), and guidelines don’t tend to structure their recommendations in this manner.

Additionally, for prescription products, Rx data (e.g. supporting “#1 dispensed”) captures a much larger number of datapoints than survey data, which often requires extrapolation from smaller samples to much larger populations. I suggest going the “#1 dispensed route” instead.

We would like to produce a non-branded APS that highlights the current medical practice on using a specific class of medication. The most recent Canadian consensus guidelines (updated in 2017) support the message that this class of medication should now be offered as an option to patients undergoing continued maintenance treatment (this is a big change vs the last consensus guidelines publication from 2003). 2 Questions: 1) We assume it would be acceptable to make a claim in an APS that outlines this recommendation, given that this is from an approved, authoritative source, correct? 2) This guideline document also provides context around why their position has changed. They provide details about how this class of medication was used historically, and also outline some of the evidence that supports their new recommendation, which included reviewing 3 RCTs among other sources (note: they communicate that there is data that supports the classes superiority, but also data that challenges it). Would it be permissible to also include a balanced presentation of these additional details in our APS? If not, why? Wouldn't a consensus guidelines document be an acceptable reprint that a company sales rep could distribute to HCPs? And if so, then why would be ok for them to distribute the document that includes this information, but it wouldn't be permitted to use the content on its own in an unbranded APS if referenced accordingly and presented in a balanced and objective manner?

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I can only speak in general terms as I don't know the particulars of your specific case. In general, Canadian guidelines can be used to support place in therapy recommendations that are aligned with the product's TMA. However, the basis for the recommendation tends to touch on topics such as comparative efficacy, safety, tolerability, adherence, cost-effectiveness, and so on. Guidelines are not an acceptable evidentiary basis for claims pertaining to these parameters. Please refer to the following document highlighting the evidentiary requirements for different types of messages in advertising:

http://code.paab.ca/resources/Marketing_benefit_claims._What_they_are_and_what_level_of_support_is_required.pdf

There are several differences between consensus guidelines and a detail aid. Arguably the most germane to your question is that consensus guidelines are created independently of the manufacturer and are therefore exempt from PAAB preclearance (provided that it is the complete and unedited document). The detailing aid is advertising which is subject to advertising regulations. You can also refer to the section "Reference texts, Peer-reviewed Journal Articles" in the Health Canada Policy Document "The Distinction Between Advertising and Other Activities.

In the "other relevant warnings and precautions" section of the highest-level fair balance, is there a requirement to include warning/precautions about effects that were not systematically studied/evaluated and that are not class warnings. Here is an examples of what I suspect needs to be included: bullet point " seizures" if PM has "seizures" bolded followed by "xxx has not been systematically evaluated in patients with a seizure disorder. Patients with a history of seizures were excluded from clinical studies. Seizures are a potential risk with antidepressant drugs. xxx should be prescribed with caution in patients with a seizure disorder." Here is an example of what I suspect does not need to included: bullet point "cognitive and motor disturbances" if PM has "cognitive and motor disturbances" bolded followed by "The effects of xxx on the ability to drive or to operate machinery were not systematically evaluated in the xxx development program." Please advice if my assumption is correct. Thank you.

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A definitive answer cannot be provided without consideration of the complete TMA in the context of the relevant area. There are times when the absence of information is an important factor in rational product selection. For example, disclosure of this absence of information is more important when there is reason to believe that the product may cause motor or cognitive impairment (e.g. say the pharmacodynamics section of the PM speaks to molecular interactions with a receptor implicated with motor or cognitive impairment, or say the product shares the same mechanism as other products in it's pharmacologic class known to cause motor and cognitive impairment). On the other hand, there's little reason to require inclusion in fair balance if the topic is included in the TMA merely for consistency with the standard monograph template.

Can baseline patient demographics (not outcomes) captured by Patient Support Program enrollment be used in HCP-directed advertising, in a promotional or claim-neutral manner?

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I assume you are asking whether you can support a statement like X% of patients with condition Y have characteristic Z. Patient support program enrollment data would not meet the standard level requirements for epidemiological statements about the disease (e.g. demographics). A published and peer-reviewed epidemiological study which is relevant to the Canadian market could be considered as could an authoritative source such as Canadian guidelines.

Another important consideration, in addition to the evidentiary issue, is whether discussion of that particular sub-population would be acceptable in the branded piece (e.g. is the subpopulation discussed in the TMA?)

Hi Patrick, I have the following question: When using the terms "proven efficacy" in a headline in the context of what the product is indicated for, why do we need high level fair balance? For example, "Product X has proven efficacy in the treatment of Arthritis." If the product has received an indication for the treatment of arthritis, it has been shown to be effective - otherwise it would not have received such an indication. So, this headline is simply a factual statement, as opposed to a clinical claim. Thanks in advance for your clarification.

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Although the indication is the evidentiary basis for a claim such as “Proven efficacy”, the statements, “Indicated in condition X” and “Proven efficacy in condition X”, are not equivalent.

The message “Indicated in condition X” is a legal statement setting the parameters around marketing and clinical use. As such, lowest level fair balance is sufficient.

The statement “Proven efficacy in condition X” is not a simple legal statement; it is a therapeutic claim. In HCP advertising, APS containing therapeutic claims (e.g. efficacy, effectiveness, safety, tolerability) are required to disclose the highest level of fair balance.

In an HTML email, does the layout need to include the full product monograph address i.e. www.Bestpharma.greatdrug.ca/productmonograph.English , or can it just read click here for Product Monograph. The word 'here' would be bolded and link directly to the unmodified PM. Please let me know.

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Yes, it is acceptable to have an available link via a prominent “click here” or a truncated URL in electronic pieces. The code does not require that the full weblink destination be spelt out in its entirety in web-based pieces where an active link is possible.

A IMC Member is questioning their obligation to submit slides to PAAB under the IMC Code Section 9.6 which states: "9.6 Speaker Training (Faculty Training) and Workshops 9.6.1 General Principle 9.6.1.1 For learning programs, irrespective of the format, on new products, new indications or disease state or significant label changes (i.e. patient safety), a need may arise to train an appropriate number of Health Care Professionals who are recognized experts on this information so as that they may disseminate this information to their colleagues for the benefit of Canadian patients. A product or indication is considered “new” up to one year after its initial marketing. " Assuming we are referring to a new drug or new indication. If the slides for these programs are developed by a scientific committee consisting of HCPs and the slides are then presented by HCPs to other HCPs - do these slides require PAAB approval since they make reference to a specific drug/use?

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Questions about membership obligations should be directed to the association(s) you belong to. With respect to the PAAB code, healthcare product advertising directed to healthcare professionals requires PAAB preclearance.

Health Canada employs the Food and Drugs Act definition of advertising and the policy document “The Distinction Between Advertising and Other Activities” to differentiate between materials that are subject to advertising and materials that are not. If you are unsure, feel free to submit a PAAB opinion such that we can fully assess the nature of the content, how it is generated (e.g. the manufacturer’s role), and all details pertaining to distribution.

As per the PAAB Code section 1.8 Definitions, the New Healthcare Product is defined as follow: "Any prescription or non-prescription product manufactured and/or marketed in Canada by a particular company for a period of less than 2 years". It is our understanding that for any APS we are limited to one year of usage of the word "New" from initial marketing. However, please clarify, what is the less than two years period in the above statement for the “New Healthcare Product" is referring to?

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Please note that the complete definition for New Healthcare Products reads “Any prescription or non-prescription product manufactured and/or marketed in Canada by a particular company for a period of less than 2 years. <em>Use of the word ‘new’ or statements implying “new” in advertising should be restricted to 1 year after initial marketing</em>.” The portion relating to 2 years relates to a category threshold used by Health Canada for administrative purposes. It has no bearing on drug advertising. The 1 year provision comes from case law and is reflected in several codes and guidances within this industry and others.

Are there any circumstances under which data from a reference arm could be included in an APS?

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Only one comes to mind. If the data is presented within the TMA. In this case, we would assess to ensure the same context and content.

I'm working on building an app for a pharma client. It's a companion for a drug they market. But I'm concerned that the review section in the App Store will put us at risk of being non-compliant. Do you have any suggestions to help?

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Have a great summer and see you in September.