In the case of a shutdown, the FDA estimates it would maintain around seventy-seven percent of its staff. This number is expected to have changed since it was reported in December 2024 due to recent staffing cuts throughout the Agency.

Of the estimated seventy-seven percent of FDA staff retained, sixty-fix percent (12,878 employees as of December 17) are termed “exempt staff” who support activities reliant on supplemental funding, rather than appropriations. Critically, these staff are maintained until their source of supplemental funding slows down. To prolong funds and make sure they are spent on the highest priority activities expect FDA to “triage programs and closely manage spend-downs of cash.” The Alliance for a Stronger FDA suggests that “ongoing activities and staff levels performing user fee activities” will likely “grow smaller in stages.” Supplemental funding sources throughout the FDA include carryover user fees, Working Capital Fund, and COVID-19 supplemental funding. We know as of the end of FY 2024, the FDA had enough carryover funding to support an estimated 9.82 weeks ($270,834,409) of PDUFA regulated activities. While there is no way of knowing exactly where these staff are positioned throughout the FDA, we do know that the estimated sixty-fix percent include:

• The entirety of the FDA’s Tobacco Center, which is funded entirely by user fees (1,303 FTE as of FY 2024).
• 622 Public Health Service Commissioned Corps Officers.

The other twelve percent of protected staff, termed “excepted staff,” support activities that are either 1) necessary to address imminent threats to the safety of human life or the protection of property or 2) or ‘necessarily implied’ from the authorized continuation of other activities. Again, while we do not know exactly where these staff are positioned throughout the FDA, we do know that the estimated twelve percent include:

• 363 Public Health Service Commissioned Corps Officers.

The remaining twenty-three percent of staff would be placed on administrative furlough. During the 2018-2019 government shutdown, many furloughed employees continued working without pay, anticipating the possibility of back pay, which was later secured through the Government Employee Fair Treatment Act of 2019. This may not be the situation this time around.

Typically, furloughed staff include:

• Individuals involved in the development of regulations or the conduct of administrative or policy work.
• A significant portion of Food program staff, apart from import inspectors, individuals working on recalls, and other front-line employees needed to address essential duties that protect human and animal safety.

Agency activity:

Drug and device product review programs are not entirely paid for by user fees; in 2018, the Alliance for a Stronger FDA estimated that about “30% of the drug review process is paid for by appropriations.” While this number has likely changed, any dependence on appropriations during a shutdown will slow the review process, even with the widespread use of user fees.

Expect staff working on products not covered by user fees to face furlough during a government shutdown. In 2018, the FDA paused:

• Non-emergency work on whole blood, blood components for transfusion, allergenic extracts, and HCT/Ps regulated solely under section 301 of the PHSA.
• The approval of products under ANDA and 351(k) biosimilar BLA.
• The approval of OTC monograph drugs, besides OTC products approved under NDAs.

Below is a series of tables including activities to expect to continue, come under threat, or halt during a lapse of appropriations.

Activities that CAN continue during an FDA shutdown include:

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