Content created by Office of Budget (OB)
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 would continue. This includes certain activities related to the regulation of human and animal drugs, biosimilar biological products, and medical devices, and all FDA activities related to the regulation of tobacco products. User fee funds specifically support the review and marketing 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, generics, biosimilars, and other medical products. User fee funding also supports FDA's regulation of tobacco products.
All FDA activities related to imminent threats to the safety of human life or protection of property would continue. This includes detecting and responding to public health emergencies and continuing to address existing critical public health challenges by managing recalls, mitigating drug shortages, and responding to outbreaks related to foodborne illness and infectious diseases. It also includes 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 related regulatory testing activities, 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 and promote public health and safety would be significantly impacted, with many activities delayed or paused. For example, for the duration of the lapse, FDA would not be able to accept new drug applications, generic drug applications, biological product applications, biosimilar biological product applications, animal drug applications, or medical device submissions that require payment of a user fee. This could delay the availability of these critical medical products. Additionally, FDA's Human Drugs Program would immediately halt most unapproved prescription drugs activities. FDA would not have the resources needed to support staff that work to protect patients from unsafe, ineffective, and poor-quality compounded drugs, unless such work is necessary to assess or address imminent threats to the safety of human life. Critical programs to advance health outcomes for patients and populations would also be negatively impacted. The Animal Drugs and Foods Program would end pre-market safety reviews of novel animal food ingredients for livestock, thus be unable to ensure that the meat, milk, and eggs of livestock are safe for people to eat; activities would be limited to those that address imminent threats to the safety of human life. Similarly, food safety efforts within FDA's Human Foods Program (HFP) would be reduced to safety surveillance and emergency responses. Longer-term food safety initiatives, including policy work to help prevent foodborne illnesses and diet-related diseases, would be halted, jeopardizing public health. Likewise, regulatory testing for medical products would be limited to activities necessary to assess and address imminent threats to the safety of human life, unless that work can be conducted with carryover user fees.
Certain research and innovation efforts would also suffer severely due to reduced resources. For example, some of 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, longer-term policy development related to national and global health security would be paused, slowing efforts to improve public health emergency preparedness and advance medical countermeasure development.
For programs without carryover user fee funding, core administrative functions such as recruitment, hiring, and staff development would face significant 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 to ensure evidence-based decision-making. FDA will be limited in the number and type of inspections to be conducted, unless the inspections are for cause or otherwise necessary to detect and address imminent threats to the safety of human life, or can be conducted with carryover user fee funding. Additionally, review work, guidance development, and pre-approval inspections related to whole blood, blood components for transfusion, and antivenom would cease completely during a lapse in appropriations, excepting work that is necessary to detect and address imminent threats to the safety of human life.
Summary of Contingency Staffing Plan
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).
Exempt Staff:
A total of 10,740 (66%) FDA staff who support activities with funding available during a lapse in appropriation will be exempt. Available funding includes sources such as carryover user fees and Working Capital Fund. For example, carryover user fee funding can be used for certain FDA activities involving products covered by user fee programs including the marketing 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 3,132 (19%) FDA staff are considered excepted. Excepted FDA staff include one HHS Officer appointed by the President and 3,131 staff who can legally continue their activities in the absence of appropriations. These staff 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 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 nonfunded 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 954 Public Health Service Commissioned Corps Officers employed at FDA. Of that amount, 596 would be exempt. The other 358 would be excepted and continue working during any lapse in appropriations.