FDA temporarily halts inspections due to Omicron COVID variant

  • January 11, 2022

Just before the New Year, on 29 December 2021, FDA “implemented temporary changes to its inspectional activities 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.”  FDA announced the changes on Tuesday, January 4, 2022…just one (1) day after the US recorded more than one million new COVID-19 cases.  While the staggering figure was driven in part by delayed reporting over the holiday weekend, the seven-day rolling average of cases in the US exceeded 500,000 on January 4, 2022.

FDA said it will continue conducting “mission-critical” work through 19 January 2022; however, will postpone other inspections for the time being.  The Agency said it will continue to conduct mission-critical foreign inspections and “reassess plans as needed” based on travel conditions abroad.  The Agency said it hopes to resume its routine inspectional activities “as soon as possible.”  FDA also said it will also be postponing its planned resumption of prioritized foreign surveillance inspections, which were expected to restart in February 2022.

In the meantime, FDA said it will continue to rely on alternative tools to supplement its oversight of drug and medical device makers, as it has throughout the pandemic.  The action echoes steps taken by FDA in the early days of the pandemic to halt most foreign and domestic inspections out of concern for staff safety and in light of travel restrictions in many parts of the country and the world.  Since then, FDA has taken a phased approach to restarting surveillance inspections, issued guidance on remote inspections and drafted a “Resiliency Roadmap for FDA Inspectional Oversight”.  However, the Agency is still faced with a large backlog of inspections despite progress made during the second half of FY2021.

REFERENCE:  RAPS; Regulatory Focus (News Articles 2022 1); 05 JAN 2022; Michael Mezher

Leave a Comment