As we sit on the eve of the longest government shutdown in history, some food manufacturers are wondering how this affects the operations of the Food & Drug Administration (FDA). The shutdown began December 22, 2018 and continues as of the writing of this post (January 11, 2019). Questions about our current system of funding Continuing Resolutions as opposed to true budgets aside, this shutdown affects the operations of all federal agencies. The FDA is no exception, and activities such as the work on guidance documents, Federal Register updates, and other routine activities have stopped.
However, much of the work performed by the FDA is considered “mission critical” for the public health and can continue to protect the public. Imminent health hazards such as outbreaks from contaminated foods fall under this exception. The FDA issued a press release on their website stating their intentions to continue to respond to outbreaks from both contaminated food and the flu.
Other types of work permitted to continue include import screenings, supporting high-risk recalls of food and medical devices, and pursuing both civil and criminal investigations when they believe public health is “imminently at risk.” The types of activities permitted to continue do not appear to include routine investigations where the FDA does not believe there is an imminent health hazard, so Preventive Controls, current Good Manufacturing Practices, and Foreign Supplier Verification Program routine investigations are currently being reported as postponed by domestic and international companies.
Interestingly, the FDA is prohibited from accepting user fee payments until a true appropriation budget or Continuing Resolution is passed for FY 2019, so the Voluntary Qualified Importer Program (VQIP) application process is expected to stall because it is a new fee-based program. The FDA will continue to support activities funded carryover user fee balances. They state on the website that this will allow them to continue to bring “new therapeutic options” to patients who need them, but that’s on the medical side.
Once a new Continuing Resolution or Appropriation is passed for FY 2019, the FDA will fire back up. The agency is traditionally underfunded and relies heavily on user fees collected to support many programs. This lapse in collections may affect the total amount collected, and it certainly inconveniences businesses that need to submit payments as the next step to advance through programs that might expand the reach of their business.
We all anxiously await the next steps from Washington, D.C. Will this shutdown outlast the historic showdown between Bill Clinton and the GOP Congress in the mid-1990s? Only time will tell!