What to Expect When You Are Expecting a Shutdown--FDA Edition
I have experienced numerous shutdowns and shutdown threats. Sadly, they have become a familiar part of my DC life. Most often, there is a last-minute deal--whether a 48-hour Continuing Resolution (CR), a week-long CR, or a 6-week CR.
No one expects a last-minute deal to happen this time. In the past, I have often been surprised when things seemed totally hopeless, only to have a temporary fix materialize out of nowhere. Let’s hope that occurs, if not today or tomorrow, then soon.
Regardless of what is being said, Congress feels the pressure and the sense of failure that accompanies a shutdown. The American people see this for what it is —a childish game— and wonder why there are no adults in the room. Additionally, it costs more money to run the government in partial shutdown mode than in full-service mode, and a shutdown has consequences for the economy that may manifest early next year and impact the 2026 Congressional elections.
At best, there will be a temporary reprieve. If there is no shutdown tomorrow, this column is likely to remain relevant in the weeks ahead.
What Happens in a Shutdown?
Today (September 30), every affected federal employee was given notice of their status for tomorrow (October 1). As a practical matter, there will be three categories: 1/ those who are expected to continue working, 2/ those who must report tomorrow and possibly Thursday to complete the activities necessary to shut down the government and they are then furloughed, and 3/ those who are immediately furloughed, laid off, or dismissed.
There are some important ground rules governing this process. First, the federal government does not “employ” volunteers, so furloughed employees are not supposed to access their work computers or continue government business. What happens, in fact, will vary by situation, project, and individual. I would not be surprised if many furloughed employees remain accessible.
Second, at least in past shutdowns, the people at Treasury and elsewhere who handle payroll have been furloughed. Therefore, regardless of whether a federal employee is working or furloughed, they are not receiving pay until after the shutdown is over.
However, one source has written that exempt employees at FDA will get paid on a regular basis until user fees run out, while excepted employees will have to wait to be paid until the shutdown is over. I was not able to confirm this today and am skeptical (but persuadable) as to the logic and logistics since user fees pay for activities not individual people. If any reader can clarify this, I will update the post to reflect their clarification.
Furloughed employees are generally not entitled to pay. However, after every previous shutdown, Congress has authorized payments to furloughed employees. In 2019, Congress passed a law to make this automatic without additional Congressional approval. Hopefully, there will be no problems in implementing the law for the shutdown that is about to begin and any future shutdowns.
Regarding federal employees who may be RIF’ed or dismissed (as opposed to furloughed), numerous existing rules would apply. How those net out (e.g., will their computers be confiscated?) will presumably be clarified today or tomorrow by the Office of Personnel Management. Reportedly, no FDA employees will be RIF’ed or dismissed (here).
FDA In a Shutdown
With most of its employees retained, the FDA will be less affected than almost any other federal agency that doesn’t provide clinical services (VA, NIH Clinical Center, Indian Health Service). However, the agency is only spared in comparison to others. There will be consequences.
The authoritative source for information is the HHS and FDA contingency plans for a lapse in annual government appropriations (HHS and FDA). Overall, HHS will retain about 48,000 employees....of whom nearly 14,000 are at FDA (not quite 29%) and 14,800 are at Indian Health Service (about 30%).
The FDA plan states: “In the event of a lapse of appropriation, 13,872 (86%) of FDA staff will be retained, including 10,740 (66%) who are exempt (their activities or position are already funded or otherwise exempted) and 3,132 (19%) who are excepted (their activities are deemed necessary by implication, or for the safety of human life or protection of property).”
In other words, a significant number of FDA employees are exempt or excepted for reasons other than user fees. For reference, user fees--both medical product and $700 million of tobacco fees--are about 47% of the agency’s FY 25 budget. Over the last few years, medical product and tobacco user fees have paid for about half of the agency’s staff, while the other half has come from appropriations.
When FDA faced this situation in 2012 and 2013, a much lower portion of the workforce was retained. In the intervening dozen years, Commissioner Makary and his predecessors have pushed hard to have FDA positioned as a public health and public safety agency that is needed at all times, including during a shutdown (here).
Thoughts for FDA Stakeholders
Those who have been furloughed are most likely to be clustered in specific non-user fee functions, such as routine food inspections, guidance development, database analysis, website management, and individuals responsible for accepting or disbursing funds, as well as other administrative tasks.
Even when teams and offices appear to be intact, everyone will be impacted by a colleague who is unavailable or by functions that are unstaffed.
User fee program-supported work is limited to funds collected by September 30, 2025. According to reports, all the programs have sufficient funding for the near future, but an extended shutdown might pose a challenge. Any application that requires a yet-to-be-paid user fee will need to wait until after the shutdown.
In a previous shutdown, FDA told me that they were going to prioritize applications (for which a fee was already paid) on the basis of which products were closest to approval. There is no way to know if they plan to repeat this.
FDA officials and staff will not be able to travel — whether to attend conferences or speak at a local venue. (As with most of these thoughts, this is based on past grounds rules that might not apply this time).
Nobody benefits from a shutdown. Let’s hope they find a way to make this a short one.
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