General Discussion
Related: Editorials & Other Articles, Issue Forums, Alliance Forums, Region ForumsEven after the shutdown ends, there will be more furloughs because of the shutdown
A friend who works in the FDA emailed:
"What I just found out: in a month, I'll be furloughed, too, because the user-fee money I'm currently being paid on will dwindle to nothing.
"FDA Commissioner Gottlieb noted that the carryover balance to run out first is likely the fees used for new drug reviews. We have about one month of funding left, Gottlieb said.
"FDA will continue to work on existing applications where user fees were paid prior to December 22, 2018, FDA can only use user fee carryover balances from FY 2018. Due to the shutdown, the FDA cannot accept new 2019 user fees."
I wrote back, "Well, maybe if Big Pharma finds out that their approvals/reviews are going to be delayed indefinitely, they can apply pressure to the GOP to end this shutdown now. Lord knows farmers not being able to purchase seed during the planting window due to federally backed loans coming to a stop hasn't....
Edited to add: More on this:
FDA will also use carryover funding to support development of medical products, he said. This includes participating in pre-approval discussions with sponsors seeking guidance on how to go forward with clinical research and other ongoing discussions to help advance development programs.
This lapse in funding, however, may limit medical product related activities. One of those includes the development of certain guidances.
We cannot accept new applications for medical products that require the payment of user fee. Gottlieb said.
He clarified the FDA cannot accept any regulatory submissions for FY 2019 for new drugs, medical devices, or biologics that require a fee payment and that are submitted during the lapse period, unless the required user fee was paid before December 22, 2018."
https://cancerletter.com/articles/20190111_9/
elleng
(130,732 posts)ehrnst
(32,640 posts)Others, indirectly will be impacted by the stopping of this work.
genxlib
(5,518 posts)Your title says more furloughs after shutdown ends.
I read this as more furloughs as shutdown continues. Some employees have remained employed utilizing user fees but the furloughs will continue as those fees run out. This is true in a number of agencies so far.
However, if the shutdown ends, funds will be available to keep people at work. And in this scenario, 2019 user fees would be allowed to be accepted.
No doubt, this is an effect of shutdown. The longer it goes the worse it gets. But I am not sure your title matches.
ehrnst
(32,640 posts)no money in the form of fees is coming in right now, because there is no processing of applications.
Had the shutdown not occured, applications submitted after December 22 would be in process, and the fees deposited. There will be a backlog when the government opens, and until that backlog is caught up, she will be on furlough.