It will only be weeks until the User Fee carryover money for all the User Fee programs runs out. While Commissioner Gottlieb is doing his best to shuffle resources, the Agency will likely be up the perpetual tributary without any physical means of propulsion soon.
Because the Agency cannot accept any new fee-paying applications since the shutdown started, for some of the UFAs, this means no work for reviewers. For others covered under the GDUFA program, there are an abundance of ANDAs from the previous year in the pipeline but, even though the work is there, soon the people won’t be because of the lack of funds.
We posted our views here of the potential long-term impact of the hold-up of submission of new applications and the likelihood of some serious backlogs when the government is funded and the flood gates open. The ten-month review clock will certainly provide some challenges to meet UFA goal dates down the road. We have attempted to find out more about the FDA’s plans for dealing with this situation but have not been able to get a response from Agency officials.
We are certainly in uncharted waters. Let’s hope the shutdown comes to a rapid end and that no more leaks spring in the FDA boat.
