PAAB Guidance on Branded Patient Information APS
PAAB has performed several client surveys in the recent past in order to obtain client input regarding a wide range of topics including PAAB Code gaps, PAAB communication initiatives, and PAAB customer service. A consistent ask from the industry has been for additional guidance on manufacturer-generated, branded, patient information for prescription drug products. Our clients spoke and PAAB listened.
Click here for the new detailed guidance document.
What constitutes current medical opinion and practice?
PAAB Code s3.2 requires that claims be consistent with current Canadian medical opinion/practice. PAAB considers a claim’s alignment with authoritative Canadian consensus guidelines as evidence of consistency with current Canadian medical opinion/practice. This is based on the fact that consensus guidelines are widely recognized to be useful aids in clinical decision-making.
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PAAB Preclearance Review Mechanism Audit Report
Recognizing that consistency in reviews has been expressed by some as a concern, PAAB took the initiative to implement an independent audit of the preclearance review system commissioned by the PAAB Board of Directors. The audit was completed by Integrated Pharma Services Inc., under the direction of Richard Khambatta, General Manager. The audit assessed the overall operational performance within the PAAB preclearance review system and the level of consistency within the system. The full audit report is available upon request. Summary slides of the results can be accessed
here...
Clarification of the PAAB Escalation Process
The PAAB is committed to providing written correspondences which clearly outline code infractions and, where possible, provide suggestions on how to move forward toward approval. However, additional dialogue is sometimes helpful to clear up areas of contention or confusion. Should the need arise, a phone call can be scheduled with a reviewer in order to obtain clarification on a review comment. Contact our administrative staff to set up a call from a reviewer.
There is also a formal escalation process for important disagreements between the client and the reviewer. Clients may escalate the review decisions to the Deputy Commissioner upon receiving a PAAB letter about the same issue which was discussed on the phone with the reviewer. This process is outlined in the PAAB Code (s8.6.ii) and in the
“Guidance Document for the Submission Process” on the PAAB website. Representatives from the manufacturer will be required to participate on an escalation call. If you wish to escalate a review comment, please contact PAAB administrators with the eFile # and the issue to be discussed.
Please note that the formal process above relates to escalations for disagreements relating to particular comments within a submission under review. The PAAB is always open to discussing concerns and suggestions about broader issues such as customer service, efficiency, and consistency. As a continually improving organization, we welcome your input. Please contact Deputy Commissioner Patrick Massad or Commissioner Ray Chepesiuk.