Omicron Forces FDA to Temporarily Shut Down Inspections

It’s déjà vu all over again. With new COVID-19 cases surpassing record highs, the FDA announced on Jan. 5 that it is once more calling a temporary halt to domestic and foreign inspections. It’s the same basic approach the agency used during the early days of the pandemic to ensure the safety of its inspectors and the companies that receive them, and honor the travel bans that went into effect around the world. This newest round of inspection delays comes a week after the agency implemented “temporary changes” to its inspection activities in response to Omicron. It’s unclear how long the latest inspection shutdown will last. However, as it did the first time around, the agency said that it will utilize alternative tools to supplement its oversight of medical device and drug makers. It also plans to continue performing what the agency described as “mission-critical” work through Jan. 19. That includes foreign inspections, pandemic and travel conditions permitting. However, it will put off routine inspections for the time being with hopes of resuming normal inspection activities “as soon as possible.” In addition, the agency is shelving its plan to resume prioritized foreign surveillance inspections in February 2022. If the previous shutdown is any indication, the agency will likely implement a phased approach to restarting surveillance inspections. During that shutdown, FDA issued guidance on remote monitoring and drafted a Resiliency Roadmap for FDA Inspectional Oversight. But digging out from the hole will become even more difficult if and when the situation stabilizes, given the agency’s failure to completely resolve the inspection backlog created during the previous shutdown.