All indications seem to be that all the User Fee reauthorizations (loving known as the UFAs) will be passed in a fairly clean bill by the end of the week. This is great news for FDA employees and for industry; however, we sure hope that they tell us what to do as that will basically give no time for firms to find out what the new fees will be and how to deal with submission of those fees for any UFA fee submission before FY 2023 begins.
We have been getting comments and questions regarding how to handle these and other issues associated with the delay in approving the UFA legislation, but FDA has been silent with regards to providing any feedback. Hopefully, the FR notices announcing the fees that are forthcoming will have some language about what to do, or perhaps FDA already has a guidance document ready to post once the reauthorization is signed.
Anyway, just know that you are not alone in your anxiety in this Congressionally created problem. The UFA is a must-pass piece of legislation so it will happen, but should we all be caught at the end of every 5-year period worrying about being in this place such as not to disrupt the process? I think I have a solution that I wrote about (here) that may be just the tonic this every 5-year period of indigestions needs. Fully fund FDA out of appropriated funds! Keep the goal dates and if industry continues to want more, then FDA will have to ask Congress for more to cover it. And while FDA is not supposed to lobby for such things, let the pharmaceutical, medical device, and other industries that are impacted do the lobbying for them!
This will also keep Congress from using the User Fee Legislation as an amendment net as catches and tack-ons any one of number of things they want to include that has nothing whatsoever to do with User Fees. They have other funding initiatives or legislative proposals they can use to tack on a net full of amendments and, in my opinion, they should not be using the net they cast on the UFA legislation to catch their fish.