Food and Drug Administration

Topics on this page: Summary of Activities that Continue | Summary of Activities that will Not Continue | Summary of Contingency Staffing Plan

Summary of Activities that Continue

The Food and Drug Administration (FDA) activities funded through carryover user fee funding and other unlapsed funding will continue.  This includes certain activities related to the regulation of human and animal drugs, biosimilar biological products, medical devices, and tobacco products. User fee funding specifically supports the review and authorization of new medical products, the review of requests to conduct important clinical research, the issuance of certain guidance documents and regulations, and other necessary activities to help patients have access to new therapies, diagnostics, vaccines, and other medical products, including important generic and biosimilar treatment options.  User fee funding also supports FDA's regulation of tobacco products.

All vital FDA activities related to imminent threats to the safety of human life will also continue. This includes detecting and responding to public health emergencies and continuing to address existing critical public health challenges; for example, this includes managing recalls, mitigating drug shortages, and responding to outbreaks related to foodborne illness and infectious diseases. Other vital activities that will continue are surveillance of adverse event reports for issues that could cause human harm, the review of import entries to determine potential risks to human health, conducting for cause and certain surveillance inspections of regulated facilities, and criminal enforcement work and certain civil investigations.

Summary of Activities that will Not Continue

In the event of a lapse in appropriations, FDA's ability to protect public health and safety would be significantly impacted, with many activities delayed or paused. Work to protect animal health would be limited, only addressing imminent threats to human life. Similarly, food safety efforts within FDA's Unified Human Foods Program (HFP) would be reduced to emergency responses, as most of its funding comes from appropriations. Longer-term food safety initiatives, including the prevention of foodborne illnesses and diet-related diseases, would be halted, jeopardizing public health and the implementation of the Unified HFP reorganization.

Research and innovation would also suffer due to reduced resources. FDA's regulatory science research, crucial for advancing product innovation, safety, and quality, would be curtailed. Interrupted studies could increase costs and delay results. Similarly, policy development related to national and global health security would be affected, slowing efforts to improve public health emergency preparedness and medical countermeasure development.

Additionally, core administrative functions such as recruitment, hiring, and staff development would face delays, compromising FDA's ability to attract and retain top talent. Critical investments in laboratory equipment, innovation, and research would also be postponed, further hindering the agency's progress.

Summary of Contingency Staffing Plan

In the event of a lapse of appropriation, 15,223 (77%) of FDA staff will be retained including 12,878 (65%) who are exempt (their activities or position are already funded or otherwise  exempted) and 2,345 (12%) who are excepted (their activities are deemed necessary by implication, or for the safety of human life or protection of property).

Exempt Staff:

A total of 12,878 (65%) FDA staff will be exempt to support activities that have funding available during a lapse in appropriations. Available funding includes sources such as carryover user fees, Working Capital Fund and COVID-19 supplemental funding. For example, carryover user fee funding can be used for certain FDA activities involving products covered by user fee programs including the authorization of new medical products, the ability to review requests to conduct important clinical research, issue guidance, and conduct other necessary activities to help patients have access to new therapies diagnostics, vaccines, and other medical products, including important generic and biosimilar treatment options.

Excepted Staff:

A total of 2,345 (12%) FDA staff are considered excepted and can legally continue their activities in the absence of appropriations. Excepted FDA staff include one HHS Officer appointed by the President and staff that fall into three categories: 1) those whose work is necessary to address imminent threats to the safety of human life, 2) those whose work is necessary for the protection of property, and 3) those whose work is "necessarily implied" from the authorized continuation of other activities.

Excepted FDA staff will continue to perform vital tasks related to imminent threats to the safety of human life including detecting and responding to emergencies, managing recalls, pursuing criminal enforcement work and certain civil investigations, reviewing import entries to determine potential risks to human health, conducting for cause and certain surveillance inspections of regulated facilities, conducting surveillance of adverse events reports for issues that could cause human harm, and other critical public health issues as appropriate. These excepted staff will also be responsible for continuing efforts to address other serious public health challenges, including medical product shortages and outbreaks related to foodborne illness and infectious diseases.

Excepted staff will also continue activities ensuring the protection of government research property, animals, and inanimate property. Examples include the care and feeding of any animals associated with research activities and maintaining research property used for regulatory science research such as high-performance computational equipment.

Additionally, staff will be considered excepted and continue to work if their duties are necessary to ensure the ongoing support and operations of activities to avert imminent threats to the safety of human life; necessary to ensure the ongoing support and operation of activities to protect government property; or if they are needed for the orderly phase down and suspension of non-funded activities. These FDA staff will continue to provide the necessary operational support to ensure the centers and offices can continue authorized activities.

Commissioned Corps:

The numbers summarized above include a total of 985 Public Health Service Commissioned Corps Officers employed at FDA. Of that amount, 622 would be exempt. The other 363 would be excepted and also continue working during any lapse in appropriations.