Role of Submission Letters in PARs
As regular readers know, the NYSID has developed and implemented a process to screen CL6 approvals for post-approval review priority. In a recent discussion of this process, the Department asked that submission letters to be as detailed as possible because they are used to prioritize files for post-approval reviews.
While one reaction to this request might be "Why should we provide additional information that could make it more likely that we will have a post-approval review?" I must confess to having had that reaction initially. It is hard not to get into a defensive mode when faced with the often adversarial feeling of post-approval reviews. However, if you put yourself in the place of the person reviewing these approvals for prioritization, and then the person writing that first PAR letter, is that really how additional quality information would be viewed?
It makes sense to think of what goes into the submission letters in the same context as that in which they will be reviewed. Most of us are used to thinking about submission letters that will be read prior to the approval of the product - and drafting them to give the reviewer a sense of what they are looking at, but leaving the actual policy forms to speak for themselves with respect to compliance. But these letters will be read for substance only after the product is approved. So it makes sense that different information would be included. In that light, some types of additional detail in the submission letter would be likely to help avoid PARs or, if the product is selected for a PAR, to get it off on the right foot.
One of the things we can do is make clear that the submission is based in NY law and we can draw a road map with respect to how the product features reflect that law. Even though the policy form compliance certification indicates compliance with NY laws, regulations and circular letters, NY submission letters are often based on generic ones and they could suggest that the product is drafted to comply with model laws/regs rather than NY-specific ones. This sense would seem to result a greater likelihood in the approval being flagged for review because it would suggest likely non-compliance and generic drafting. But if the submission letter describes the product clearly and in relation to NY laws and regs instead of models, it seems likely that the chance for a PAR would go down, absent any unusual product features that raise issues of their own. Specifically identifying and indicating a familiarity with the NY laws and regulations that apply to the product in the submission letter would seem to be a very beneficial thing to do in light of the prioritization process.
Because we are used to thinking about submission letters as being read prior to approval and because that is no longer the case in NY, the impulse might be to think that they don't serve any purpose - that they can only hurt and cannot help. That might be true if the PARs were random. But with the NYSID's prioritization process in place, I think that these letters may be one more area where some additional effort up front can save a lot on the back end!
