PAAB changes to application/requirements for pieces
-
Hello,
I recently submitted a piece with an approved claim of "X years in Canada across indications," and found out that PAAB is now requesting that the year of each indication's NOC be added to the claim. Would it be possible for PAAB to provide an explanation of why this change happened, why the code was previously considered in accordance with the code, and also would it be possible for PAAB to provide notices when general changes on how PAAB decides to interpret and apply the code are made? It is difficult for us to explain to clients on why PAAB suddenly feels that the content violates the code, as no explanation is provided on the change.A similar example is that directing HCPs to pre-gate websites now requiring a disclaimer, no notice was given to agencies prior to receiving response letters requiring this disclaimer. These changes in how the code is interpreted and applied creates a lack transparency.
-
Hi @username,
Without knowing the specifics of the file you are speaking to; we can convey that experience claims tend to have nuances to them that are set by the context around them which the reviewer can help you better understand in the context of the review. In the context of this being the only claim on the page, the copy “X years in Canada across indications” is inherently misleading as not all indications have been authorized for X years. It creates an erroneous impression for time on the market for some indications. For this type of experience claim, the underlying PAAB code section 2.1 and principle has not changed. The request for clarity and accuracy regarding years of experience have been applied for many years with the initial appearance of such claims in advertising.
We do our best to inform clients about changes and will continue to look for opportunities to do so. When an issue does not affect a large number of pieces, we do tend to error on the side of conveying the change in files when the issue is noted. This helps to ensure that we are not overwhelming clients with every review ruling. We can look for opportunities to increase that scope and frequency.
In the second example, there has been no change to the requirement to disclose to HCPs when you are directing them to content that was designed for consumers or patients. The perception that this is a change might be rooted in the fact that PAAB noted that clients were adding consumer messaging to HCP pre-gate landing pages. As such, we would ask for the clear disclosure that they were being directed to content intended for a consumer audience. The nature of the content on the pre-gate page changed, which is what prompted the request. The application of the Code did not change. The reviewer can help explain the nuances of your example in the file. Please reach out through efiles.
