Thoughts on NY Outlines
Over the last few months as more and more of my NY workload is comprised of post approval reviews, I have been thinking about the NYSID outlines. I have serious questions about the value of the current process of trying to reach a consensus between the industry and the Department on various interpretations of laws, regulations and circular letters as well as the limits of the Department's discretionary authority on a variety of issues prior to publishing revised outlines. The result of this process is that no outlines get published at all.
The problem is this: The outlines on-line are between 5 and 10 years old for the most part and they no longer accurately reflect many positions of the NYSID. Those positions ARE reflected in the post-approval review letters, but no where else. That means that these positions are selectively enforced, based on which companies' products happen to be reviewed post-approval. It also means that companies do not have any resources to consult for the NYSID's current positions prior to making CL6 filings.
While it would be great if the industry and the Department could work quickly and effectively to examine positions, develop revisions to those positions and publish them on-line, many years have shown that not to happen - at least not in a timely manner. The group term product outline has been touted as the closest to being ready for publication for years now. Yet it has not been published.
I would like to see publication of the Department's positions as they are. Of course, I would love to see some movement in some positions that the department takes, but for my clients, that is secondary to knowing what is being enforced NOW.
We have seen the Department do this in some instances. Typically this has been in the form of guidance on particular issues and that is appreciated. What I am asking for is something more. I am looking for outlines that reflect the standards for post-approval reviews today, whether I agree with them or not. It is more important to my clients from a compliance and disciplinary action viewpoint to KNOW what will be sought on post-approval review rather than to wait for the possibility that some interpretation will change somewhat. In my experience, the actual movement on interpretations through this process is minor. There are few radical changes in Department positions that result from the outline drafting process. So what do we really gain from all the delay?
I know in my office, I compile the comments and objections I see on PARs. I imagine others do too and I certainly would expect that the NYSID has a compilation of the objections they raise that do not appear in the outlines and are new or different interpretations. Again, those are the positions we need to know about when we are doing certified filings. And we need to know them in real time as they develop.
The current outline process started when I was at the department over 10 years ago. It may have worked when we were in a slower paced, prior approval environment and even as we began certified filings. But today things move so much more quickly and approvals and post-approval reviews happen much too quickly for that old process to work any longer. We need current information quickly.
I would like to volunteer me and my staff to work with the Department on putting together such a process. I think it is only fair to the companies doing certified filings to make the information necessary to minimize the risk of those filings available in a timely manner. It can be done, and I would like to see it get done.
I am so there !!