Q&A: Shutdowns at FDA Are Complicated
Q: How likely is a government shutdown on October 1 (the beginning of the new fiscal year)?
A: As described in this week’s Advocacy at a Glance, a Continuing Resolution (CR) will be needed and the Senate is hoping to add additional disaster relief funds and additional military support for Ukraine. Conservatives in the House Republican caucus have said they won’t vote for a CR without substantial concessions from the Senate and President.
There is no obvious way to get a CR passed by October 1 and official Washington is girding for a possible government shutdown. Hard to give odds, but there is a significant probability of a shutdown of unknown duration.
As a footnote: October 1 is a Sunday. That leaves room for a “symbolic” shutdown that might extend from Saturday midnight into the early hours of Monday morning when OPM has to tell federal workers whether to report to work.
Q: What are the FY 23 FDA Lapse Plan and the 2023 HHS Contingency Staff Plan?
A: We have heard these described as “the plan” for FDA if appropriations lapse on October 1, 2023. They are not. They were created and are accurate only for a potential lapse on October 1, 2022, a year ago.
Nonetheless, until the FY 24 plans are released (later in September), these documents are the best guide we have. However, interpretation and implementation of “who works and doesn’t work” are subject to change. They were noticeably different a decade ago. Additionally, all the numbers will be different to reflect growth in FDA’s headcount and possible changes in the mix of employees.
Q: Knowing the numbers will change–and possibly underlying policies and interpretations–are there ways to ascertain who is most likely to be working and who is not?
A: The FY 24 plan, when released, will specify that “x% of FDA employees will be retained” and “y% will be furloughed.” Behind those numbers:
Members of the Public Health Service Commissioned Corps will be working
Also unaffected would be individuals working in areas where their absence would constitute a threat to public health and safety or property.
Emergency inspections would be staffed, but presumably not routine ones.
Criminal enforcement work and civil investigations related to imminent threats to human health or life will be staffed.
The FDA would be staffed to continue to address existing critical public health challenges, including drug shortages.
Not working: Most individuals who are involved in the development of regulations or the conduct of administrative or policy work.
Distribution will be uneven.
Food programs (more than 5,000 employees of CFSAN and CVM) are likely to be thinly-staffed, apart from emergency inspectors and other front-line employees who are responsible for human and animal health and safety.
The Tobacco Center is fully funded by user fees and presumably 100% will be working.
Note that policies may have changed since last year and that will have some impact on who is included in each category.
Q: Will staff supported by user fees be among those who will be working during a shutdown?
A: In a shutdown, FDA cannot collect user fees. User fee activities are thus limited to how much carryover funds are in each user fee account as of September 30.
In a short shutdown, there will presumably be enough money to cover all ongoing activities. In a longer shutdown (as in 2018-2019), the amount of carryover funds could become an issue with regard to continuation of activities.
Q: Where can stakeholders turn for additional information?
A: The Alliance will be on full alert throughout September and until the threat of a shutdown has substantially diminished or gone away. Send your questions to sgrossman@strengthenfda.org. We will answer them in Friday Update or in special mid-week editions.
Also, we are in the process of updating a “shutdown toolkit” that we distributed in the lengthy shutdown that occurred five years ago.
Editorial Note:
The Analysis and Commentary section is written by Steven Grossman, Executive Director of the Alliance for a Stronger FDA.