FDA pauses domestic drug inspections again, this time to protect against Omicron
The FDA quietly announced on Tuesday that just before New Year’s eve, the agency again paused all of its non-mission-critical inspections in the US, likely leading to an even larger backlog of inspections worldwide.
The pause, which will last at least two weeks, is meant to ensure the safety of FDA employees and the companies it regulates as the agency further adapts to the spread of Omicron.
“Through Jan.19, the agency intends to continue mission-critical work but has temporarily postponed certain inspectional activities with the hopes of restarting these activities as soon as possible,” the FDA said in a statement.
The agency had only just returned to relatively normal domestic inspections last July, after a long previous pause that began as the pandemic hit in early 2020. In a report from last November, the agency noted that 52 new drug applications were delayed as a result of the inspection backlog created by that long pause.
On the foreign inspection side, where activities have still been mostly on pause since early 2020, FDA said it’s postponing the planning of prioritized surveillance foreign inspection assignments that were scheduled to begin in February 2022.
But the FDA said it will continue conducting mission-critical foreign and domestic inspections.
Between April and September 2021, the FDA said it completed just 37 foreign drug inspections, which compares with more than 1,200 in 2019.
And the FDA’s total tally for drug and biologic inspections in 2020 shows how the agency conducted 1,500 fewer inspections in 2020, when compared to 2019 (and over 2,600 fewer when compared to 2011). Only 74 inspections ended with an Official Action Indicated in 2020, which compared with 202 OAIs in 2019.
The agency has sought to shift to more remote assessments of facilities, but that hasn’t proven to be a major help as the backlog is filled mostly with surveillance inspections, and the legal definition of an inspection is one that is conducted on site.
