263 - Has the PAAB ever considered a "priority review" stream, whereby Clients could receive a shorter initial review (3-5 days vs 10) for a higher fee ($1000, $2000, etc)? There are occasions where guaranteed expedited timing is vital, and this option would serve the industry while generating additional revenue for the PAAB. To restrict use, Submission Coordinators could limit Files to those of formulary/safety content, or those of shorter length.
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Yes. PAAB has considered this. You'll note that complexity of HCP advertising review is at the core of most concerns. But I'd like to raise an ethical concern first. Specifically, creation of two separate fee streams may accentuate imbalances in the market place (e.g. smaller manufacturers & agencies may find it harder to access the priority stream due to budgetary reasons). Fairness is an important ingredient for a healthy preclearance system. I am uncertain what benefit the proposed system would have above and beyond the existing system if access to the priority stream was limited to APS which are simple and short. PAAB already does what it can to expedite such files when client expressed needs intersect with PAAB capacity to help. Under the proposed system, I suppose we'd need to ignore all requests for rushes in the regular stream as accommodating such requests would be unfair to those who paid extra for that privilege. This also leads to other interesting questions like "What happens when the regular fee stream is below day 10?" For example, I suspect it would appear unfair for your competitor to have received a day 6 response on the regular stream ($450) if you've paid $2000 to receive your response on day 5. It would be hard for clients to assess the cost-benefit of paying extra unless the size of the "benefit" was static/fixed. Would this mean that, when the priority fee was not paid, the PAAB could not respond until day 10 (even if the review was completed long before day 10)? Say the turnaround times were not static/fixed, wouldn't stakeholders come to suspect that reviews for the regular stream are intentionally slow so as to induce clients to pay the higher rate for the priority stream? In my experience, most projects are "priorities" by the time they are submitted for PAAB pre-clearance. The complexity of HCP advertising review would make it difficult to deliver on the priority commitment. This means that additional staff would be required (which further adds to complexity as the specific number of staff required would be difficult to forecast and the training period is such that it takes at least 6 months before new staff contribute in a meaningful way). If most projects go into the priority stream, the proposed structure essentially acts as a sizable fee hike. Note that a shortened first response time does not necessarily equate to a fast approval. Other key factors include how long revisions stay on the agency/manufacturer end before getting sent back to PAAB and how many rounds of revisions are required. Client efficiency is a key determinant of how long the file stays on the client end, while response quality is a key determinant of how many rounds of revisions are required to get to approval. Ultimately, it may be worthwhile for our clients to consider whether their interests are best served by investing in their own internal processes rather than the proposed system which essentially adds up to buying a few days on the PAAB end.
