FDA was hoping to have the User Fee Bill passed and to begin work on publishing fees and the accompanying Federal Register Notices that must go out ahead of the September 30 expiration of the funding measures. Remember, FDA must have legislation in place in order to request the fees, collect the fees, and spend the new money that comes in for the fees. In addition, there is a lot of work that must go on behind the scenes at the Agency to get things in place so the industry will know how much, when, and if it need to pay fees under the new set of UFAs (User Fee Authorizations).
This year, with a change in the GDUFA fee structure and the advent of a new Program Fee, FDA will be struggling to get the information out to industry in a timely manner. From recent report, it appears that the bill should get approved prior to the Congressional August recess. The Association for Accessible Medicines (AAM) is urging Congress to act quickly (see here).
I am sure there are some nervous folks at FDA who are anxiously awaiting Congressional action. While FDA should still have some carryover money from past UFAs to avoid sending out layoff letters to employees, there certainly must be an urgency felt by the Agency as well as potentially affected staff. There is a push for a clean bill to avoid any delays in conference, so let’s hope the deed gets done quickly and FDA can get on with its now compressed timeline for getting things in order for the new UFAs in place for an October 1 implementation.