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.
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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.
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While verbal correspondence between the sales representative and the healthcare professional does not fall under the PAAB scope of review, it is a promotional activity and as such it is subject to advertising regulations. Per section C.08.002 of the Food and Drug Regulations, promotion of a drug and/or indication, prior to market authorization is not permitted. We suggest advising sales representatives to direct HCPs to call the manufacturer’s Medical Information Department in response to these unsolicited questions.
