Please see AskPAAB questions #587 and #455. (search “gating” and “gate” for further information)
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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.
Hello, We would like to know if PAAB would accept the following tool: A desk-calendar for HCPs to use as a counselling tool for when they are scheduling the next dose of a vaccine. It would also feature facts about the disease and best practice tips. Thank you.
Although the concept itself of creating a desk-calendar which can be used to council patients is possible, here are a few suggestions to try to ensure a smooth review process. First and foremost, this is HCP advertising and as such is subject to PAAB review. As the piece will be viewed by both HCPs and patients, it must be clear what information is intended for which audience. Finally, based on the question, it sounds like this will be a branded piece. Be cautious that the disease information does not go beyond the products TMA (i.e. it is on-label).
We're developing a pull-up banner and the amount of Fair Balance is not allowing for space for the message. Could we apply the principles allowed for journal ads? Specifically, have medium fair balance on the pull-up banner and direct the reader to a handout adjacent to the panel with the full fair balance?
No. The specifications for using middle level fair balance to link to highest level fair balance, are that it is within the same tool (e.g. Print tool X cannot direct the HCP to the separate print tool Y for highest level fair balance) AND in the same medium. As in a journal ad, this would mean later in the same journal; the highest level fair balance should appear within the pull-up banner somewhere. If the space required for fair balance is not sufficient, we suggest revising the nature of the claims to require only middle or lowest level fair balance.
Hello, If we want to do a video about the Mode of action of a drug, apart from the PM, what other references can we use?
Authoritative sources such as published medical text books, can be considered as additional support for the content within the TMA. The content should not go above or beyond the specifics of the TMA.
In a company sponsored presentation, can a physician talk about off-label for another drug (not the sponsors drug) e.g. "In my practice I use Drug X to treat nausea", but Drug X is not indicated for nausea.
No. All advertising content should be consistent with and within the limitations of the products respective product monographs. Off-label uses should not be discussed for any products.
Is it voluntary to get promotional materials approved and simply acts as a benefit to the product or is it this process mandatory?
Please see AskPAAB Question #670 (search “required”) for response.
Jennifer Carroll
Senior Reviewer Communications
Pharmaceutical AdvertisingDinner Meeting
Cocktails: 5:30 p.m.
Dinner: 6:00 p.m.
Panel Discussion: 6:30 p.m.