FYI post-approval change/preclearance exemption/what requires review/PAAB scope
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767 - It is not uncommon for employees in a sales or marketing function to have the name of the product they support in their email signatures. If such an employee sends an email to a HCP and attaches materials that are not specific to a product (i.e. unbranded disease related) does that attachment now become an APS and therefore subject to PAAB review due to its association to the product name in the email signature?
• Jennifer Carroll -
763 - When and why was the following removed from the PAAB code? Disease information materials which make no mention of treatment by name, class, or category AND are not linked to healthcare product advertising in any way, are exempt from PAAB preclearance. Does it not still apply?
• Jennifer Carroll -
750 - We are creating a gated patient website that will show clinics near the patient's location. After initial PAAB approval, is it possible to continue to update the list of available nearby clinics as they open/close/move? Or are those updates subject to PAAB approval again, even if it is within the approved year?
• Jennifer Carroll -
752: My question is specifically regarding a sales rep emailing a (known, consented) HCP one on one with: A) A one line message that a product has now received Health Canada approval with approved indication. No claims, data etc B) A request to HCP to discuss Patient Support Program which may include info on the PAAB approved patient enrolment form Is this communication different if a Medical Affairs staff member sends the email? thanks very much.
• Jennifer Carroll -
750: I’ve reviewed your forum and website but my colleagues and I still have varying views. If a product receives Health Canada NOC, may an employee in a sales role email an HCP with this information with no efficacy claims? Would an employee in a medical affairs position be able to send same email? Is there a difference in who may send communication? Thank you.
• Jennifer Carroll -
749: We are looking to develop a corporate email that would be sent by the reps to outline the opportunity to communicate virtually with them. The layout would be corporate branded with no mention of any brands. The content simply outlines the benefits of a virtual call and how to connect/steps to make a video call. Would this type of information be exempt from PAAB review?
• Jennifer Carroll -
740 - 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.
• Jennifer Carroll -
739 - 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?
• Jennifer Carroll -
706 - Can sales representatives provide information on a drug's reimbursement criteria in response to a question from a HCP if the reimbursement criteria are not aligned with the TMA. For example, the approved Health Canada indication is for use as 2nd line therapy but the drug is only reimbursed for use in 3rd line. Could the sales representative respond to the question and provide information on reimbursement if not aligned with the TMA. Thank you.
• Jennifer Carroll -
699 - A pharma company wishes to produce an Unbranded video that will be used by reps for a call with HCPs. The video will feature a patient campaign that has already been approved by PAAB. There are no claims being made in the video, and it just provides an emotional story behind the campaign. Would this be considered PAAB exempt?
• Jennifer Carroll -
698 - Could you clarify a few points for us: 1 - Is a product indication (verbatim from the product monograph) seen as a claim by PAAB? 2 - If a detail piece, journal ad etc., contains only branding colours, brand name and product indication, does PAAB need to review this or is it exempt? 3 - Per question 2 above, if the piece also contains imagery related to the indication, does that change the PAAB review requirement? Thanks for the clarification.
• Jennifer Carroll