Consequences of an FDA shutdown at the beginning of FY 22
What an FDA Shutdown at the Beginning of FY 22 Might Look Like
Through our Friday Update archive, we have a contemporaneous account of the 2018/19 shutdown on FDA. The initial rules in 2018 were different from 2013 and evolved as the weeks went on. However, changes during the shutdown did not eliminate the bulk of damage done, but only fixed some especially egregious situations.
Without seeing the FY 22 rules—likely to be released by HHS on Monday or Tuesday—we cannot be certain that what we wrote 3 years ago will reflect what will happen this time. However, many features of shutdown protocol are inherent to the situation.
Here are the “set-up” columns, comparable to where we are now. They reflect rules as we understood them. There are also links to earlier documents:
https://strengthenfda.org/2018/12/15/is-a-shutdown-on-the-horizon/ (December 15, 2018)
https://strengthenfda.org/2018/12/21/advocacy-at-a-glance-341/ (December 21, 2018)
https://strengthenfda.org/2018/12/21/what-happens-at-and-after-midnight-cinderella/ (December 28, 2018; what happens each day at the beginning of a shutdown)
Note that there were several factors in 2018…that would not be the case now.
Funding for HHS was already enacted into law, so only FDA (Ag funding bill) and the Indian Health Service (Interior funding bill) were subject to furlough and the rest of HHS was unaffected.
It was late December when a significant percent of the workforce had scheduled leave, plus there were federal holidays—so the initial impact was less that it would likely be October 1 this year.
Timing:
Usually CR’s end on Friday, which gives Congress until the wee hours of Monday morning to reach a deal (in time for OPM to tell workers whether to come to work). That is, the bulk of federal employees who work weekends—military, security, etc.—are exempt from furlough.
In contrast, this year the fiscal year ends on a Thursday, so Congress cannot give itself that leeway without a short CR extension…. although the President can, by declaring that a deal is close enough (a subjective call, for sure) so that government can keep working at least on October 1.
User fees: not nearly as cut and dried as it might seem. Among other things:
User fee funds are task-allocated, not people-bound. There are no “user fee people” who automatically get to show up. Supervisors will have to decide activity by activity and person by person. Also, people who come in to do user fee work (or other exempt work) cannot work on other projects just because they are in the office.
Assuming it follows past shutdowns, starting October 1, there will be no one to accept and deposit user fee checks….so: 1/ the balances in user fee accounts as of September 30 are what is there to spend 2/ those funds will not last forever and each user fee programs will have different balances, different rules for prioritizing work (some set by statute).,3/ anyone who can file/pay filing fees before October 1 might consider doing so because it might affect how much work FDA will do on their application during any shutdown. Presumably, this will not apply to COVID-19 work, assuming all that work is allowed to continue unaffected.
To varying degrees, product reviews are paid by appropriations as well as user fees. As a result, there are certain to be cutbacks in review activities during a shutdown for lack of appropriated funds--even before you get to any limitations imposed by the available balances in each user fee fund.
We speculated that FDA would prioritize products closest to approval and for which any review fees had been paid for prior to the shutdown. To the best of our knowledge, that is what occurred.
The payroll situation (at least in 2018) was: people who were working and not furloughed accrued their pay but did not receive it until after the shutdown ended. People who were furloughed did not accrue pay…they are dependent on Congress subsequently passing legislation that reinstates their pay as if they had been at work. While I believe that has always happened, it is not guaranteed.
Editorial Note: The Analysis and Commentary section is written by Steven Grossman, Executive Director of the Alliance for a Stronger FDA.