FDA Updates on Inspection Backlog Caused by Covid
FDA appears to be making progress in the backlog of inspectional work needed to render review decisions on outstanding medical product applications that were delayed due to the Covid-19 pandemic. In May, the agency released its “Resiliency Roadmap for FDA Inspectional Oversight” report (see earlier story) that said 68 applications were delayed solely due to a pending inspection or facility assessment.
In a 11/22 Resiliency Roadmap update, FDA now says it has conducted inspections or facility assessments that supported decisions for 30 of the delayed applications, including all seven that were deemed “mission-critical applications.” However, since the roadmap was published, FDA has received 31 new applications that require inspections and the backlog of application-related inspections stands at 61 delayed applications, according to the update. It also says that nearly 90% of the delayed applications require foreign inspections or assessments. “FDA will prioritize the completion of application-related foreign inspections, provided U.S. State Department and other information to ensure safe travel,” it says.
Regarding other routine inspectional activity, FDA says it has completed more than twice as many domestic surveillance oversight activities than projected in May. With over 15,000 domestic surveillance inspections postponed since the beginning of the pandemic, FDA projected performing about 2,000 of these by 9/30. Instead, FDA’s update says it completed more than twice as many domestic surveillance oversight activities than projected in the Roadmap. “FDA’s development of new oversight approaches and expanded use of a variety of surveillance tools signifcantly contributed to the agency’s ability to exceed these goals,” the update says.
Meanwhile, FDA Office of Regulatory Affairs assistant commissioner Elizabeth Miller earlier this month outlined how the agency has embraced the flexibility and information-enhancing abilities that alternative inspection tools, such as remote interactive evaluations, have provided compliance and enforcement staff during the pandemic. She acknowledged that while FDA does not intend to replace traditional inspections with remote interactive evaluations (RIE), it will, however, use inspections supplemented by additional tools (e.g. hybrid inspections), such as requests to participate in teleconferences, live streaming video of a facility operations, screen sharing of records or other real time activities.
Miller explained how RIEs are not the same as an inspection, and as the agency learns more and decides how and when these and other tools can be used, “it is committed to having transparent dialogs with regulated industry as to how this may affect our procedures in the future.” Internationally, Miller said ORA is working in collaboration with other regulators to share their alternative inspection experiences. “As with all regulators, we are evaluating how these remote tools and activities provide assurances and efficiencies,” she said.