For prescription products and products for the treatment of a schedule A disease, a message of “new” or “now available” would be considered promotional and therefore would not be acceptable.
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Can branded DTC advertising include a claim of 'new' or 'now available'?
For prescription products and products for the treatment of a schedule A disease, a message of “new” or “now available” would be considered promotional and therefore would not be acceptable.
Can HCP branded materials and Patient branded materials utilize the same creative? If not, how different must the 2 be? What elements (colours, key features) can be shared between the two campaigns?
Please see Q&A #123.
We have an 8 page print leave-behind detail aid that includes full dosing information. We are thinking of redoing this tool with a half page sized tear off flap that has key reminder information on the dosing. Does this flap have to contain all of the dosing information, or can it just contain e.g., the steps and an example calculation. Thanks.
This would require a separate review of the tear off pad to ensure it meets the standards of the code as a stand alone piece. Often information which is required in an APS is based on the specific claims made and whether or not those claims require qualification. That said, in theory it may be possible to create a half page piece with selective dosing information, however this will be highly dependent on the product’s monograph and claims being made. The selective dosing information would generally require a prominent disclaimer “For more information related to dosing and administration please refer to the product monograph” and any dosing related cautionary copy or safety related issues would likely be required in the APS.
Change in Product Ownership - if Company A divests Product X to Company B, can Company B continue to use promotional material for Product X that was previously approved by PAAB for Company A during the DIN transfer, or only post-DIN transfer? If so, can it be used until the renewal date?
Please see Ask PAAB question #74.
Hi PAAB, I was wondering if expert guidelines for treatment option algorithms (first line, second line) are allowed to be included in branded pieces directed at HCPs. The goal would not be to compare treatments but to see under which situations / for what patients a therapy would be preferred. (Patient profile?) Thanks for your help!
This question has two parts to it. First, lets address “expert guidelines”. For consideration as evidence to support place in therapy messages, we first look to Canadian consensus guidelines, to ensure consistency with current Canadian medical opinion. In the absence of Canadian guidelines we can consider US or North American guidelines. Please see AskPAAB #593 for more guidance on the use of non-Canadian consensus guidelines. The guidelines must be endorsed or recognized by an authoritative medical body and it should be nationally recognized. It is not sufficient for the guidelines to simply be published and peer-reviewed. With respect to off-label content, guidelines cannot be used to support treatment recommendations which extend beyond a product’s monograph.
The second part of this question relates to the content in the APS which the guidelines are intended to support (i.e. “see under which situations/ for what patients a therapy would be preferred”). We can consider guidelines to support claims related to “place in therapy”, however patient selection may entail broader topics (e.g. concomitant conditions, age, gender, etc.). Selection of one first-line product over another generally suggests comparative significance, for which consensus guidelines would not be an acceptable source.
My client is preparing an HCP website that will include brand promotion as well as offer samples. The site will be 'gated' which will involve a landing page that asks the viewer if they are a Canadian physician and require that they input their license number. Does the website require a validation process to ensure that the license numbers and the physician name are accurate? Could the 'validation' be limited to ensuring that the correct number of digits/letters are input (as opposed to confirming that those numbers match to a licensed physician). I look forward to your feedback. Thank you! LC
Do OTC product materials require PAAB review? Does this change if they are rep delivered materials vs online (or other multi-channel mediums not driven by sales resp)?
Dear PAAB, The Product Monograph of one of our products has been updated with a new indication. We want to send a message to physicians informing them that the PM for AAA product has been updated with the results of BB study. Since there is no claim/indication in this message, our understanding is that this message is PAAB-exempt. Can you please confirm? Thank you.
A message of “new indication” would be promotional (promotes the feature of a product) and incomplete (what is the new indication). This is not considered an exempt message. Please see PAAB section 1.5 for exempt messages. A message similar to “new data within the TMA” is also a promotional claim and does not fall under the exemption criteria.
For messaging on formulary coverage, in accordance with the PAAB Advisory March 2019, while it is PAAB exempt to state "Drug X: Now on ODB Formulary", can a manufacturer also provide the HCP (along with the PAAB exempt message that the Drug X is on ODB Formulary), a link to the listing criteria on the "ODB Formulary" associated with that particular Drug X?
Please see Ask PAAB Question #577 (search “formulary”).
Would it be acceptable to use an image in a patient support material (PSP) if the same image is being used in healthcare professional branded material? The product only has one indication and PSP material would specifically be distributed to patients prescribed the product for the approved indication.
The fact that an image has been used in HCP branded advertising does not make it ineligible for use in patient information. Keep in mind however, that unlike HCP advertising, patient information cannot be promotional. So a key distinction is whether or not the image itself is promotional, in which case it would not be acceptable for a patient tool. This same concept applies even if the PSP is not overtly branded. In other words, by using imagery from a branded piece, the PSP becomes branded and as such should meet the restrictions of a branded patient piece.
Jennifer Carroll
Senior Reviewer Communications
Pharmaceutical Advertising