FYI post-approval change/preclearance exemption/what requires review/PAAB scope
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The responses, guidance, and advisories provided by the Pharmaceutical Advertising Advisory Board (PAAB),
including but not limited to those available through the PAAB Forum, the PAAB website, and any PAAB
correspondences, are specifically intended to assist individuals navigating the PAAB preclearance system.
Repurposing or reproducing this content without written consent from the PAAB Commissioner is strictly
prohibited. This prohibition includes, but is not limited to, use in machine learning or AI models.
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615 - Hi, I have a question regarding receiving pre-clearance from PAAB regarding promotional material related to a new product that has been approved under the NOC/c (Notice of Compliance with conditions) policy, as stated in the Qualifying Notice received from HC? Is this mandatory, or optional? Thank you!
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603 - Hi, We were thinking of providing our reps with iPad covers that have images from a campaign that we intend to launch. The iPad covers will be solely for the reps and won't have any sort of messaging on them, but will have the names of our brands. Do we need to put the covers through PAAB? Thanks.
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576 - We are in the process of developing a tool that will highlight a product's reimbursement program. It would state "reimbursement navigation assistance available for Product X" and would include a tear pad with necessary information to be completed by an HCP. This tear sheet would not be provided to patients, but would be faxed directly to the manufacturer. In addition, this tool would not include any product/promotional claims, only the name of the product would be mentioned. Given that messages limited to name and price are exempt from PAAB review, would "reimbursement navigation" also be considered exempt? If not, is there any way to make this tool exempt?
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568 - Questions in regards to provincial formularies: 1. Would providing the name of the "product now on province formulary" statement with the inclusion of the din number for ordering be considered exempt from PAAB? 2. If the link to the complete provincial formulary is included would this be considered the same as including the coverage criteria for the product? 3. Is including the complete provincial formulary link and directing to the section or page for product "X" be considered as providing the coverage criteria and thus requiring PAAB review?
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565 - Could you please clarify the formulary message for the province of Québec. If a company mentions the following message: “Drug X: Now on RAMQ formulary (médicament d’exception code)” and not linked in any way to additional product messages or disease/corporate messages. We would not allude to the indicated use and will add the RAMQ TM. Is the above mentioned text still PAAB exempt or not. Are we in the obligation in Québec to provide code and coverage criteria every time we mention RAMQ reimbursement (then subject to PAAB). I have read the information on the PAAB website, but still having different interpretation/confusion on this. • Memo dated April 15, 2016 - Advisory regarding use of Régie de l’assurance maladie du Québec (RAMQ) in APS • PAAB ADVISORY guidance on Provincial Formulary Coverage Statements • Q 519 in the Ask PAAB section
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535 - The manufacturers of a drug would like to provide patients (via HCPs) with a wallet card that alerts the patient to show the card to healthcare professionals to remind them to check for potential drug interactions. This focused bit of information is consistent with Part III. Does this require PAAB review?
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524 - Hi PAAB. Do communications sent in the context of a patient assistance program need PAAB preclearance? here is the situation. we have a patient assistance program for which we would like the vendor to use a standardized and automated system to communicate information pertinent to patient's enrollment status, notifications regarding reimbursement investigations, reminders of missing information to proceed with the service etc... The issue is that all of our Patient assistance programs are named after the therapeutic area (XYZ-Onclogy; XYZ hep C, XYZ HIV...) and within the body of the letter we have to specify the name of the product for HCP to know which product the communication is related to. These communications begin after a physician has made the decision to prescribe the product and decided to enroll his patient into the program either for reimbursement investigation or compassionate...
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500 - Can you advise on PAAB's role/interpretation of 'drug delivery system' advertising? Examples wold be prescription drug inhalers, injectors, etc. Would advertisements focused solely on the delivery system/technology be exempt from PAAB (perhaps as a medical device), or seen as an extension of drug advertising (and reviewed in the same manner)?
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492 - We will be running a webinar from our HCP website. The webinar will be delivered by an internal medical expert. The webinar content will be on-label and pre-cleared. HCPs will need to register for the webinar on the "events" section of our gated HCP website. This section would only contain a list of upcoming webinar events. The description for the webinar would include; title, date, time location and a basic bio of the speaker. If the webinar title does not include mention of any specific products and the remaining info is purely factual details about the event date, time & speaker credentials, does this content need to be pre-cleared by PAAB?
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491 - Healthcare professionals have asked for demo syringe kits to show patients how to inject. Would this be something we would submit to PAAB for review? It would have the product name on the box, and include: demo syringes, a squeeze ball, and a dose card in the kit that was previously PAAB approved? Would it matter if a dose card was not included? To summarize, does a demo kit fit Code Section 6.6 (iv) .....use of a drug name only in a context not linked to therapeutic or promotional messages. Or is it considered a Service-Oriented Vehicle under Code section 6.4, even if it's a demo kit?
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486 - Dear PAAB, Would a message that makes reference to the brand name and indication of a company's vaccines, that is intended to be posted on the company's intranet, for the purpose of informing the company's employees on what vaccines the company makes and which disease they intend to prevent, be considered promotional and require PAAB preclearance? if yes, would it make any difference if a disclaimer is added to prevent employees from sharing the information with outside people? Thank you!
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