Brick by Brick: The Final Stretch

We’re closing in on comments-due on 8 August 2014. If you haven’t commented, I urge you to do so by then. I will be submitting my own comment as well.

The process from 9 August 2014 is for the FDA to read all the comments they have not yet read, process them, and then formulate their new view of the matters at stake. Then they will amend the proposed regulation and it goes through the OMB loop again, letting them push back a bit. And then it eventually gets finalized.

Once finalized, the fun really starts. Lawyers of various stakeholders will begin helping them formulate their compliance behaviors for the new rules (larger and more established companies probably already have regulatory compliance work ongoing, but it will have to be modified and extended to fit the new rules). Lawyers will also begin considering how challenges to various provisions of the rules on various grounds might play out.

The provisions will all have effective dates, compliance periods, and so on. The companies will have to decide whether they want to force the issue on certain provisions by failing to comply entirely or let the FDA come after them for partial compliance, etc. Posturing will go on. The media will do whatever it is that they do. Throw darts at the proposal and print the words they land on?

But right now we still have time to finish our comments. For a little under a week, anyway. And then we get to wait for the final rule. Or maybe another comment period. If the FDA believes enough has changed once they reformulate, they could offer us another chance to comment, on an updated proposal. I actually think this may be the case.

We asked the FDA to extend the comment period, which they did. But they didn’t extend it very much. A very strange move, that. My guess is that either they don’t think the comments matter very much, or they feel that enough will change that spending too much time on first-round comments will be somewhat wasted. Given the comments do tend to matter, I lean toward the latter.

Keeping it short today, as I want to spend more time on my comment. Good luck!