What to Expect When you are Expecting…a Government Shutdown
February 18, 2025The government is currently funded through March 14th, 2025. Come Monday March 17th, if Congress does not pass a budget or continuing resolution, the FDA will enter a shutdown and shutter many offices and programs while Congress works out their inter-party squabbles on national priorities. While the political process plays out many FDA employees will be furloughed and told to not report for duty.
The question that is always on the mind of folks in FDA-regulated industries is, “what does that mean for my application/inspection/meeting?” The answers below are based on my experience as a reviewer and compliance officer at FDA during the 5-week 2018/2019 government shutdown.
What does it mean for FDA staff? If your position is exempt from appropriations, you may be asked to remain at your station and working while other FDA employees are furloughed. Most of FDA’s reviewers are exempt, while compliance, policy, and administrative support are typically furloughed.
What does it mean to be furloughed? When you are furloughed, you are expressly forbidden from working as you are not being paid. One’s furlough status during a shutdown can also be in flux. If you are a reviewer and you run out of user-fee work, you become furloughed until the shutdown ends or if user-fee work is assigned to you. Furloughed staff from other programs can be brought back into working status on an “as needed” basis to specific tasks.
Examples:
- A manager has three approval letters to review and a binder of lot release papers. Once those reviews are complete, the manager is furloughed for the rest of the day and goes home.
- A critical amendment to an IND is received. The staff required to process the submission are recalled from furlough to input the submission into the system so it can be reviewed by staff. Once processing is complete, the staff are returned to furlough status.
Drugs/Biologics/Devices/Tobacco (CDER, CBER, CDRH, CTP) – These centers are largely supported by user-fee programs that support their review staff (MDUFA, PDUFA, BsUFA, GDUFA). This means that while most of the FDA will be in shutdown mode, submissions under these agreements proceed as normal. The monies collected from the user-fee programs give FDA months of additional runway in the event of a funding lapse by Congress. The amount of runway that FDA has is dependent on the user-fee program. Each user-fee program is its own separate pool of money that is used to fund the review operations. During the 5-week shutdown in 2018/2019, PDUFA funding was the most robust and could have funded several months of review operations. Based on my own experience as a reviewer during the 2018-2019 shutdown, reviewers with active user-fee files continued their jobs without interruption.
What happens to my NDA/PMA/BLA/510(k)/IDE/IND under review? You should not expect a meaningful change to your review progress as a result of a short or moderate-length shutdown. It is only if a shutdown lasts a couple of months or more that programs may begin to run out of funding and have to furlough review staff. Some behind the scenes activities do get more difficult as some of the supporting program staff will be furloughed.
What happens to my Pre-submission or Type A/B/C/D Meeting? While these meeting requests do not have a specific user-fee tied to them, they are under the umbrella of the user-fee agreements and the staff working on these submissions are not furloughed. You should expect written response-only and teleconferences to proceed largely uninterrupted, but face-to-face meetings may not be possible due to support staff furloughs
What happens with Inspections and Compliance? For normal surveillance operations, those inspections are largely, if not entirely, funded by appropriations. If the shutdown were to occur on Monday March 17th, inspectors may be recalled from active or on-going inspections to be placed on furlough. For pre-license or pre-approval inspections, the outcome of a shutdown is less draconian as these are under the auspices of a user-fee program.
Example: I was scheduled to conduct an international pre-license inspection in early February 2019, and we continued planning for that activity assuming that the shutdown was not going to last until that date. In the event that the shutdown was still in effect, management indicated that the inspection could still proceed, but there would be significant logistical challenges with many of the necessary folks to sign-off on items being caught in the furlough.
For most of the compliance staff, when a shutdown hits, they are furloughed as compliance operations are generally not under a user-fee program. There can/will be exceptions to this as there are programs and specific projects that are critical to health, but one should not count on calls or emails being returned until after the shutdown ends.
Will FDA accept new submissions while shutdown? Submissions to FDA that have an associated user-fee will not be accepted during a government shutdown as they do not have the ability to process the payments (PMAs, 510(k)s, PFUDA Program Fees). For the submissions that do not have an associated user-fee (INDs, IDEs, Pre-submissions, certain supplements), these submissions may be accepted and reviewed. User-fee submissions sent to FDA will be placed “in the queue” for formal processing and acceptance after FDA returns to normal operations.
If you are preparing a submission to FDA in the next few weeks, you may want to consider the ramifications of the March 14th government funding deadline and plan accordingly.