• As of the time of this blog’s publication, without either a fiscal year 2019 appropriation or a Continuing Resolution, a partial government shutdown, which began on December 22, 2018, has continued to impact departments and agencies across the federal government. Both the U.S. Department of Agriculture and the U.S. Food and Drug Administration are directly affected.
  • In an announcement regarding the lapse in funding, FDA will continue activities within the scope of its user fee funded programs, including those for prescription drugs, generic drugs, biosimilars, medical devices, animal drugs, and tobacco products. FDA will also continue activities to respond to outbreaks, manage high-risk recalls, review import entries, and other activities critical to public health. However, the announcement notes that FDA will not be able to support some routine regulatory and compliance activities, including some medical product, animal drug, and most food-related activities. In addition, FDA will pause routine establishment inspections, cosmetics and nutrition work, and many ongoing research activities.
  • Starting January 1, 2019, a number of USDA activities have not been continued, including payments for agricultural research, issuing loans for rural development, etc. USDA announced that it will continue other activities beyond January 1, 2019, including meat, poultry, and processed egg inspection services, grain and other commodity inspection, weighing, grading, and IT support services funded by user fees. The full press release regarding the shutdown can be found here.