FDA Outlines Plan for Inspections in Wake of COVID-19By
The US Food and Drug Administration (FDA) has issued a new report outlining the agency’s inspection activities during the COVID-19 pandemic and detailing a plan for future inspection activity, including the FDA’s priorities going forward.
In March 2020, the FDA announced that it was temporarily postponing all domestic and foreign routine surveillance facility inspections while continuing mission-critical inspections when possible. Beginning the week of July 20, 2020, the FDA began to work toward resuming prioritized domestic inspections using its COVID-19 Advisory Rating system.
The FDA conducted a total of 821 mission-critical inspections from March 2020 through March 2021, including 29 in foreign countries. Additionally, the agency conducted a total of 777 prioritized domestic inspections since resumption of that work in July 2020. Of the more than 13,500 applications for medical product approval or authorization received since March 2020, an estimated 68 applications have been delayed due to the inability to conduct inspections, with a majority of those not deemed to be mission-critical, according to the agency.
The report outlines inspections that the agency was unable to complete during the past year due to travel restrictions or inability to ensure the safety of its workforce or the workforces the agency regulates. The report also outlines the number of mission-critical inspections the agency completed during that time, such as inspections of facilities for which there was a drug shortage, inspections needed for the approval of novel drugs or drugs related to the potential treatment of COVID-19, and support of pre-market and pre-license applications.
Additionally, the report outlines the FDA’s continued use of alternative tools and approaches where inspections were or are not currently feasible, including remote interactive evaluations (e.g., remote livestreaming video of operations, teleconferences or screen sharing), record requests, and leveraging information from regulatory partners.
The report further outlines the ongoing steps the agency is taking in order to resume standard operational levels of inspection activities, including how it intends to prioritize domestic and foreign inspections that were not performed during the pandemic. The plan highlights a variety of possible scenarios given the continued uncertainty of the trajectory of the ongoing pandemic. Inspections considered critical to the FDA’s mission will remain the primary focus.
When planning routine surveillance inspections, the FDA says it will prioritize higher-risk establishments. Therefore, a longer interval between inspections will occur for the less high-risk facilities as the FDA adjusts to the impact of the COVID-19 pandemic. This means that postponed inspections will be prioritized based on risk and conducted over a longer period of time, thereby ultimately increasing the amount of time between inspections of certain lower-risk facilities.
The agency says it will soon begin a multi-year modernization effort to further transform data enterprise platforms and cross-program interoperability infrastructure to better support innovation related to its regulatory oversight role, including remote approaches. The FDA is also establishing an agency-wide FDA Inspectional Affairs Council that will plan and coordinate inspectional activities.
Source: US Food and Drug Administration