“Protecting the health and safety of our staff and their families is of paramount concern to the U.S. Food and Drug Administration,” FDA said in a statement. “As a nation we must do everything we can to help slow the spread of the virus and help flatten the curve of the COVID-19 pandemic. Now more than ever, the American people are depending on us. We must ensure our workforce remains healthy to carry out the FDA’s critical public health mission to keep Americans safe.”
 
All eligible FDA employees will now begin working from home. This does not apply to those conducting lab activities, such as those monitoring imported products. Adjustments will be made to how the agency approaches facility inspections for food, animal feed, drugs, biological products, devices, and tobacco.
 
This announcement came on the heels of a recent agency decision to postpone most foreign facility inspections, aside from inspections deemed mission-critical, such as those in response to serious adverse events reporting.
 
Domestic for-cause inspections will be considered, and will proceed if determined to be “mission critical,” the agency said. “We will continue to respond to natural disasters, outbreaks, and other public health emergencies involving FDA-related products.”
 
FDA Commissioner Stephen M. Hahn highlighted some alternative strategies the agency might employ while the crisis runs its course.

“I want to assure the American public that we have full confidence in the safety and quality of the products we all use every day and that the FDA will continue to leverage all available authorities to continue to ensure the integrity of the products we regulate,” Hahn said. “Importantly, during this interim period we’re evaluating additional ways to conduct our inspectional work that would not jeopardize public safety and protecting both the firms and the FDA staff. This can include, among other things, evaluating records in lieu of conducting an onsite inspection on an interim basis when travel is not permissible, when appropriate. In fact, inspections are just one part of a robust and multi-pronged approach to overseeing the safety and quality of FDA-related products, however inspections are not what cause quality to happen.”

Industries will still be required to fulfill cGMP reporting, which details operating procedures, manufacturing, sanitation, and processing controls, as well as preventive controls reducing or eliminating food safety hazards.
 
“From our experience across the agency, we also believe FDA-regulated firms understand and appreciate their shared responsibility to ensure the integrity of the supply chain and we will continue to communicate with them during this time to underscore this partnership,” Hahn said. “In fact, in last fiscal year, the overall domestic violation rate was only about 5%.”