Omicron Causes FDA Suspension of Most U.S. Inspections Through Jan. 19

Jan. 10, 2022 – The Food and Drug Administration’s (FDA’s) ability to catch up with its inspection backlog caused by the COVID-19 pandemic is slowing again after the FDA temporarily postponed many inspectional activities in the United States through Jan. 19 and deferred foreign inspection assignments that were slated for February 2022.

According to an FDA notice published last week, this action is an extension of the temporary inspection changes announced Dec. 29 that are designed to ensure the safety of its employees and those of the firms it regulates “as the agency further adapts to the evolving COVID-19 pandemic and the spread of the omicron variant.”

“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 notice states. “The FDA will continue conducting mission-critical foreign inspections and will reassess plans as needed based on its monitoring of foreign travel conditions.” According to the notice, the agency “also is postponing the planning of prioritized surveillance foreign inspection assignments that were scheduled to begin in February 2022.”

However, the FDA is continuing to conduct some domestic inspections. “State inspections under FDA contract have the discretion to make inspection decisions based on their local information,” the agency stated on Jan. 4.

Catching up with these inspections – which were backlogged before the COVID-19 made matters far worse – is a priority for the agency, which reported in its November 2021 “Update to the Resiliency Roadmap for FDA Inspectional Oversight,” that 52 human drug applications were delayed solely due to a pending inspection or facility assessment.

In March 2021, the Government Accountability Office issued a report asking the FDA to address its inspection strategy for eliminating the COVID-19 backlog. In April 2021, the FDA issued a final guidance document on remote interactive evaluations (RIEs) of facilities where drugs are manufactured, processed, packed or held, of facilities covered under FDA’s bioresearch monitoring program, and of outsourcing facilities. These RIEs will continue as long as there is a public health emergency. The FDA also awarded a $1.2 million contract for a remote drug inspection pilot program.

Despite those initiatives, the House Energy and Commerce Committee leaders put pressure on the agency over the summer to come up with solutions to address the continuing inspections backlog and its effect on drug approvals; it is worth noting that 2021 drug approval numbers were strong even though some inspections were delayed.

One thing that new programs and a continuing sense of priority cannot entirely overcome is the pandemic, which is putting a wrench in the FDA’s best-laid plans. FDA Commissioner nominee Robert Califf, M.D., likely will be asked to tackle this problem moving forward. To learn more about what the FDA will look like under Califf, register today for a Jan. 21 CHC webinar featuring Nancy Bradish Myers, president, Catalyst Healthcare Consulting.

For now, the FDA has stated that “Importantly, the agency is continuing remote foreign supplier verification program activities for human and animal foods, as well as leveraging other remote tools to maintain oversight of foods, drugs, medical products and tobacco.”