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
Congress provided The Food and Drug Administration (FDA) its appropriations for FY 2026 (FDA) will not be impacted by a lack of congressional action in January. FDA will be able to continue its activities through September 30, 2026, with the 16,089 staff currently onboard.
Exempt Staff:
N/A
Excepted Staff:
N/A