As of July 1 2013, Provided the fair balance is formatted per the guidance on the PAAB website (which includes a URL to the complete product monograph) the publication is not required to contain the PAAB format prescribing information.
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As of July 1 2013, Provided the fair balance is formatted per the guidance on the PAAB website (which includes a URL to the complete product monograph) the publication is not required to contain the PAAB format prescribing information.
I think you are referring to the base fair balance (correct me if I am mistaken). The base fair balance may appear inside of the booklet. Of course, there are times when a specific claim on the cover triggers the need for a particular element of the fair balance to be presented on the cover (i.e. copy-specific balance).
As of July 2013, the PAAB code will require content setting the boundaries of patient selection from the Indication and Clinical Use section of the product monograph to be presented on the first surface containing drug claims. This requirement is already in place for new products, but it will apply to all healthcare product advertising reviewed by PAAB as of July 1st 2013. If this information is already conveyed in the NOC/c box, there is no need to repeat it.
This type of question is best answered during the review or prior to it in the context of an opinion submission. In general, the efficacy results of a controlled trial are only interpretable in the context of both the treatment arm and the control arm (along with the corresponding statistical significance). Based on the limited info I have about your scenario, I'd have to advise reflect the PM (i.e. show both versions with the corresponding stats).
I'd like to provide a useful response. But doing so would require me to get more information. Please call me at 905-509-2275 to discuss.
We are considering a partnership that will allow us to place unbranded, disease awareness information into a variety of large public health portals. The portals contain disease awareness information but also have separate areas that disseminate drug specific information. (We are not providing any drug specific information.) As part of this partnership, we are being offered the ability to have banner ads run throughout the site. The ads are not just for our unbranded content. There is the potential for us to have branded ads that point to our gated product-specific website. The banner ads are "run of site" and there is no influence on where they appear within the portal. There are two possible situations that we are concerned about.
These situations are out of control but may occur. Does this make us out of compliance with the spirit of the DTC advertising code?
Generally, in a run of site context, those linkages should occur very rarely in a large/diverse portal (or sets of portals). The same random incidents occasionally occur in print publications. The core principle is that the manufacturer (or its agent) should not take steps to influence the ad environment in such a way that promotes the general public's ability to associate the product with its therapeutic use. Unlikely random incidents which are not under the manufacturer's or agent's control are unlikely to cause the manufacturer to be non-compliant with the consumer advertising regulations. For example, from a statistical perspective, the Arbace ad will appear much more frequently with unrelated condition content (e.g. mood disorders, erectile dysfunction, menopause, pain...etc.) than with disease content relating to its indication (i.e. hypertension).
Having said this, these electronic portals provide the opportunity to set exceptions to the run of site command. For example, in my Arbace example, it is simple to allow for run of site except for pages containing the keyword hypertension. Many clients are doing this as a best-practice to make sure their advertising does not contravene (or appear to contravene) the regulations.
In the new PAAB code, it says: "The PAAB can allow the use of observational studies when specific acceptance criteria are met." What are the specific acceptance criteria? Also, does a natural history study fall under an 'observational study' or 'meta-analysis'? Thanks
A natural history study is a type of observational study which simply follows a group of people (e.g. on a drug or having a condition) over time. They tend not to have a control group and thus would not be considered as evidentiary support for claims in drug advertising.
A high quality cohort study or case-control study can be considered as evidence for adherence claims. These two groups of non-experimental trials can also be considered corroborating evidence for therapeutic claims of efficacy and safety. The guidance document on our website provides more information on observational studies.
For any analysis (including observational studies and meta-analyses) "high quality" means that adequate steps were taken to ensure that the observations are not due to random luck or systematic bias (whether methodological or confounding). This can only be assessed if the study report is comprehensive. For observational studies we look to the STROBE checklist, for meta-analysis we look to the PRISMA checklist. These checklists do not tell you whether a study is high-quality, but they do tell you what parameters one needs to know in order to make that assessment.
It is sufficient to submit the French copydeck with the English layout.
Is including the names of Rx products on sales rep business cards and email signatures allowed ? Or are these considered APS or potentially DTC advertising . Thank you
It appears that there is a chance that these cards will fall into the hands of consumers. We must therefore consider consumer regulations. The name of the drug alone would not exceed consumer regulations (provided the drug is not a narcotic or a controlled drug as consumer promotion of such products is completely prohibited). However, inclusion of anything which would allude to the therapeutic use of the listed drug (e.g. a drug rep title such as "Neuroscience Specialty Mood Representative") would exceed consumer restrictions for prescription products and for products used for the treatment of a schedule A disease. It is advisable to limit distribution to HCPs if including anything beyond the company name/address, the drug rep name & contact info, and a generic title such as "Product Representative". Should distribution be limited to HCPs as they contained specific drug rep types, PAAB would review these as corporate pieces with product mention. All cards across the company's product offerings may be submitted as a single piece. For each product we'd ensure the implied therapeutic classification is accurate and on-label. Note that inclusion of product claims would require fair balance.
The following response was drafted by our file coordinators. Please contact Laurie or Sabrina at the PAAB office if you have any questions. Submissions which require full review will receive a first response within 10 business days. Direct to Consumer pieces and Opinion requests receive a first response within 4 business days. Subsequent responses will be received in 3 business days.
You may submit to PAAB for review, finalized copydeck or layout for the initial review, copydeck to be followed by a final layout prior to approval of an advertising piece. Please include the most recent product monograph and the Health Canada approved letter which supports this monograph. All references should be uploaded to the electronic submission and cross referenced on the copydeck or layout in a manner directing us precisely to the support for each claim. Responses will be emailed to the current email address that we have for your personal registration within the efile system. The final approval letter will contain your PAAB acceptance ID # for future reference. An invoice initiated at the time that the first response has been sent to you. For a more detailed explanation of the submission procedures, please refer to the Submissions Guidance Document on our website.
In side-by-side comparisons of non-therapeutic information from Product Monographs, it is not necessary to include all comparators with the same indication. The comparison should be representative of the section of the Product Monograph that it is based on and should not be selective as to which attributes are included.
Jennifer Carroll
Senior Reviewer Communications
Pharmaceutical Advertising