Sharp Reductions in FDA Operations Under Shutdown: HHS
FDA would experience sharp reductions in operations if Congress fails to reach a deal to fund the government and avert an ensuing shutdown, which now seems likely to occur beginning 10/1, according to contingency plans released by HHS. While critical safety functions and some drug and device reviews funded by industry user fees would continue, many public health activities would be delayed or halted.
HHS says 13,872 FDA employees — about 86% of the agency’s workforce — would continue working during a shutdown. Of these, 10,740 are considered “exempt” because their activities are supported by carryover user fees or other non-lapsing funds, and 3,132 are “excepted” because their work is deemed essential to protecting human life or property.
Under the contingency plan, FDA would continue to review applications for drugs, biologics, biosimilars, and medical devices that are supported by user fee funding. It would also carry on with activities related to tobacco regulation, monitoring adverse events, responding to foodborne illness outbreaks, managing recalls, mitigating drug shortages, and conducting “for cause” inspections of regulated facilities.
However, many other functions would be suspended. HHS says that during a shutdown, FDA would not be able to accept new applications for medical products that require user fee payments, potentially delaying the approval of new drugs, generics, biologics, and devices. Oversight of unapproved prescription drugs and compounded medicines would largely stop unless tied to imminent safety threats. Pre-market reviews of novel animal food ingredients would also be halted, raising concerns about the safety of meat, milk, and eggs entering the food supply.
Longer-term policy and research work would be among the hardest hit, according to HHS. FDA’s regulatory science research could be interrupted, increasing costs and delaying results. Efforts to advance national and global health security, including medical countermeasure development, would also be put on hold. Routine food safety initiatives designed to prevent outbreaks and diet-related diseases would be paused, leaving only surveillance and emergency response in place.
Other consequences would include delays in hiring, recruitment, and laboratory investments, as well as the suspension of regulatory testing for blood products and antivenom unless tied to immediate safety threats.