Ask PAAB

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.

• View Answer [+]

  ---

  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.

• View Answer [+]

  ---

  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?

• View Answer [+]

  ---

  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?

• View Answer [+]

  ---

  Please note that the complete definition for New Healthcare Products reads &ldquo;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 &lsquo;new&rsquo; or statements implying &ldquo;new&rdquo; in advertising should be restricted to 1 year after initial marketing</em>.&rdquo; 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?

• View Answer [+]

  ---

  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?

• View Answer [+]

  ---

  As the concern is that consumer generated content may contravene the regulations, one option is to deactivate the review section (this may be possible depending on the particular App store in question). Alternatively, you could monitor the reviews and have them corrected or removed if they contravene the regulations. More information on monitoring can be found in the guidance document https://www.paab.ca/resources/Online_Activities.pdf

  Guidance document for Online Activities - paab.ca www.paab.ca PAAB Supplementary Guideline Online Activities 2012-FEB Page 3 of 22 INTRODUCTION The growing popularity of online forums to share information and connect with a virtual

In a DTC Consumer Brochure discussing treatment options for a given disease, can narcotic treatments be included in a balanced list of treatment options? We are assuming a Consumer Brochure is not defined as advertising under the Narcotic Control Regulations s70.

• View Answer [+]

  ---

  You are correct in that a piece meeting all the provisions of the consumer brochure would not be considered advertising (and would therefore not be subject to advertising regulations). I advise caution though. If you inadvertently execute the piece in a manner which happens to render it subject to the advertising regulations, NCR 70 would come into play. I therefore strongly urge you to submit the piece to a preclearance body for a DTCI advisory opinion. Be particularly vigilant about focusing mostly on disease information (as opposed to creating a tool which is mostly about drug therapy) AND ensure that all treatment options (pharmaceutical and non-pharmaceutical) for the specific condition are discussed in a manner which is balanced with respect to risk and benefit. The complete list of provisions can be found in Health Canada’s policy document “The Distinction Between Advertising and Other Activities”. If any competitor would not likely be just as happy to sponsor this piece, you may be threading on dangerous waters.

We would like to do a table comparing non-clinical aspects (indication, route of admin, dosing, monitoring, etc.) of various products indicated for a specific disease. There are more than 10 drugs with this indication, so it will contain a lot of information, all of which will be based on the respective product monographs. It is our intention to give each brand equal prominence (i.e., it will not be specifically branded to one drug). What are the balance requirements for a piece like this? Normally, we understand that dosing warrants high-level balance. However, we can't possibly fit high-level balance for all of the product that will be mentioned in this piece. What do you suggest? Thank you!

• View Answer [+]

  ---

  Please note that dosing messaging in and of itself does not prompt requirements for the highest level fair balance. Dosing messages limited to optimal administration of the product(s) would generally be subject to lowest level fair balance.  However, we note that your question mentions a comparison of indications and monitoring warnings. In HCP advertising, comparison of indications, contraindications, warnings and precautions, drug interactions or overdose would trigger the need for highest level fair balance.  

  The piece would require review to determine the appropriate level of fair balance.

  We’ll need to consider more than simply the type of content in the piece. For example, we’d need to consider whether the piece qualifies for editorial provisions outlined in code section 7.5.  You may consider submitting the piece for an opinion (see the fee schedule on our website).

Dear PAAB, Our Pharmaceutical Company is planning to do a Patient Support Program gated website; we will send this website to PAAB for review. We would like to add links to an independent patient association website that has different resources for patients. If we link to the home page of the patient association, will PAAB need to review the entire website even if we with a disclaimer that they are leaving the company website? Can we link to separate documents (e.g. disease state , treatment options)? In this case does PAAB need to review each document ? Since our website is branded are these going to be reviewed as branded pieces? Thank you.

• View Answer [+]

  ---

  When setting out to link branded and unbranded content, all content becomes branded. It is possible to link to third party independently created website from a standard setting organization (i.e. reputable patient associations). We suggest that the link be made to the homepage, in which case the PAAB would assess the link as part of our review of the Patient Support Program submission to ensure that the linkage is not off-label. However, if the manufacturer were to link the submission to specific sections of the independent site (instead of the simply linking to the home page), the PAAB would need to perform a complete review of those sections as one or more separate submissions. Those reviews would be performed under a product branded lens.

Are there any limitations for using Phase II studies as support for therapeutic claims, apart from disclosing the Phase II nature?

• View Answer [+]

  ---

  Whether you are using a Phase II or a Phase III study to support therapeutic claims in advertising, the same standards apply:

  • Clinical or therapeutic claims must be based on published, peer-reviewed, controlled and well-designed studies with clinical and statistical significance clearly indicated. The study (and the claim you wish to base on the study) must meet all relevant criteria listed in the PAAB code and the PAAB guidances.

  and

  • The study must be consistent with and within the limitations of the TMA

  The PAAB code does not specifically differentiate between phase II and phase III studies. Having said, keep in mind that phase III studies are much more likely to meet all the criteria listed in the PAAB code and PAAB guidances than phase II studies. If unsure of the acceptability of a study as the evidentiary basis for a particular claim, consider submitting a opinion request (see the fee schedule on our website).