A quarterly review of the eFiles tag report 

Total number of submissions

QUARTER 1	QUARTER 2	QUARTER 3	QUARTER 4
2969	2621	2452	2104

 Total number of client tags (prior to validation) 

QUARTER 1	QUARTER 2	QUARTER 3	QUARTER 4
0	17	21	12

Tag submitting company and manufacturer distribution 

QUARTER 1	QUARTER 2	QUARTER 3	QUARTER 4
0	5 & 9	7 & 8	3 & 4

 Therapeutic area breakdown

QUARTER 1	QUARTER 2	QUARTER 3	QUARTER 4
0   Not tags to report	7 Oncology 2 Gastrointestinal 1 Biologic / Immunomodulator	4 Endocrine & Metabolic 1 Dermatology 1 Immunology	7 Biologic / Immunomodulator 4 Oncology 1 Vaccine

 Total number of tags deemed valid following internal review

QUARTER 1	QUARTER 2	QUARTER 3	QUARTER 4
0	10	6	2

 

Validated tag breakdown

QUARTER 1	QUARTER 2	QUARTER 3	QUARTER 4
0	4 Inconsistent with code guidance 3 Inconsistencies with historic approvals for the same brand 2 Request unclear after clarifying call  1 Issue with level of expertise	2 Inconsistent with code guidance 1 Call not returned at agreed upon time 1 New issue raised late in the review 1 Particularly helpful comment 1 Issue with level of expertise	1 New issue raised late in the review 1 Inconsistent with code guidance

NEW: Q4 PAAB action taken:

For the tag on “New issue raised late in the review”, the issue was identified in the first round but was missed in the second and was caught on the third. The perception that the issue was adequately addressed is valid and reviewers have been reminded to double check that all issues have been addressed prior to sending the response. We’ll continue to track to ensure this does not become a trend.

Reasons for not validating a tag:

The tag “The requested revision was unclear to me even following a clarification phone call” was used when no call was requested or occurred. This tag should only be used when a call has occurred, otherwise it will be deemed invalid.

The tag “Inconsistency perceived because objection to content previously approved for the brand was maintained after directing PAAB to the prior approval file” is often invalidated when the client does not provide backfiles. For this tag to be valid, the client needs to provide relevant past files or concurrent files and a response needs to be provided in order for a reviewer to reconsider an issue. As a reminder, backfiles should be provided upfront as part of the initial submission.

Q3 PAAB action taken:

The issue raised about inconsistency with the code guidance was accurate and identified a training opportunity for the individual reviewer. The Director of Preclearance also presented the case at a reviewer meeting to ensure a consistent understanding of the code sections application was held across the office.

In the case where a call was not returned, the issue had been addressed in an email which was not received. The administrative staff will ask for confirmation of receipt to help address this issue moving forward.

Reasons for not validating a tag:

In a number of instances, the revision to the claim in question was not as the reviewer requested and the revised copy prompted a comment. The client viewed this comment as a new issue. It’s important to remember that copy is reviewed and approved as the totality of the presentation. When copy changes that effects other aspect or copy is added, it may prompt a comment that appears new, but would not qualify as “new comment late stage” because it’s been prompted by a change the client made. Nonetheless,  this did prompt a reminder to reviewers that clearly explaining this at first mention of the comment may help to reduce this perception.

“Perceived issue with expertise” with no additional context. A complete review of the file did not appear to have any aspects that would warrant or support this tag  In another case, a potential inconsistency was tagged as an expertise issue which was not an accurate use of the tag. PAAB added an inconsistency tag that was deemed valid in that case. As a reminder, adding additional context to a tag can help in the validation process. It helps the Director of Preclearance focus on the specific aspect that the client felt was an issue.

In another instance of this tag, the issue raised appeared to be based on not providing enough guidance around what had been done with the brand in the past. From a PAAB training perspective, we did remind the review team to provide accurate backfiles when they are readily available. As a reminder to clients, it is the clients’ responsibility to be familiar with their brand and previously discussed claims, copy, images etc. Sponsors should have access to all backfiles and communications. Sharing/requesting these when agency changes occur or turnover happens, may help to alleviate this issue.  

For tags regarding “Inconsistency perceived because objection to content previously approved for the brand was maintained after directing PAAB to the prior approval file”, these cannot be validated when previous approved presentation was not within the same context.  The same words when presented in a different context may not have the same message.    

Q2 PAAB action taken:

One key issue raised was not being clear on an issue even after a clarifying call. In both instances, the issues had been previously discussed in a past file, so the reviewer did not re-explain. Reviewers have been directed to reiterate the rationale for revisions to facilitate understanding. A trend across the “inconsistent with historical approvals” was that new information had been brought forward since the previous approval. Reviewers have been reminded to clearly convey this to clients when applicable and provide the rationale for why it requires changes to previously approved copy.

A case was identified where a reviewer was inconsistent with the guidance. Discussions with the review team were had on the application of guidance in relation to non-clinical claims.  

Q1 PAAB action taken:

No tags reported in Q1 of 2023. As a reminder, both CEI and Tags are important and serve different but complementary purposes. Additional details can be found in the PAAB resource Client Tagging System Advisory

Confidence in confidentiality As a reminder, client tags trigger internal audits for validation by PAAB’s Director of Pre-clearance Services, Yin Man. Any tags pertaining to Yin are validated by the Commissioner and removed from the report provided to Yin. No Reviewer, Senior Reviewer or Director is EVER aware of tags generated by clients. You can be confident in the confidentiality of the tagging system. For additional reassurance, the tagging system, tag assessments, and documented actions taken will periodically be reviewed by an external auditor. What does PAAB use the tags for? Staff and system performance metrics To identify trends and training opportunities To stay inform on what is going well (best practices) and areas for improvement If you’d like to learn more about the client tagging system, check out the Client Tagging System Advisory. You’ll also find links to useful videos on  tagging a review and tagging phone calls.

Is there more information you would like to know and see in the next quarterly update? Let us know on the Forum.