FDA Outlines Contingency Plans for Shutdown

The U.S. Food and Drug Administration (FDA) contingency plans for a lapse in appropriations funding can be found here. FDA’s plans state that “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.”

“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.”

Under the Antideficiency Act, the only agency activities that are allowed to continue during a shutdown are those that are:

  • Funded outside current-year appropriations;
  • Specifically authorized by law to continue in the absence of appropriations;
  • Implied to continue in the absence of appropriations;
  • Required for the President’s constitutional duties; and
  • Related to emergencies where there is a reasonable likelihood that the safety of human life or the protection of property would be compromised.

These activities are open to interpretation and OMB gets to set the rules during a potential shutdown.