25 November 2021
More than a year and a half into the COVID-19 pandemic, the FDA has started to right the ship on the pace of its domestic drug manufacturing inspections. Still, the agency continues to struggle with oversight of foreign plants, and a growing number of new drug applications are facing delays, a report shows.
FDA site reviews in the U.S. largely returned to normal in July. With the lifting of pandemic restrictions that month, the agency has since pulled off what it called a "best case scenario" for pandemic oversight. Things are going so well at home, in fact, that the FDA exceeded its own expectations for the number of U.S. inspections it could conduct for the remainder of 2021.
Outside the U.S., though, the FDA continues to be hamstrung by COVID-19 demands. Between April and September 2021, the regulator carried out just 37 foreign drug inspections, three foreign animal drug inspections, four foreign medical device inspections and two foreign biologics inspections. Before the COVID era, the FDA typically conducted around 1,000 foreign inspections per year, Endpoints News points out.
Meanwhile, there are now 52 new drug applications facing delays because of the agency's pandemic inspection backlog. That's a slight increase from the 48 delayed applications the agency reported in May, back when it first unveiled its "roadmap" to get COVID-scuppered inspection activities back on track.
In March, the agency estimated that there were more than 15,000 domestic inspections that had been postponed because of COVID-19—a number that included drug, device and food plants. At the time, the FDA predicted it could complete about 14% of those inspections in the 2021 fiscal year, including 26% of outstanding medical product inspections.
By the end of September, however, the FDA had completed more than twice that number. On the drug and medical device front specifically, the agency says it's completed 1,139 inspections out of 3,229 outstanding.
The FDA has also turned to a combination of remote and in-person work to carry out its assessments. The agency says it has conducted more than 600 remote regulatory assessments in the U.S. and more than 200 remote assessments abroad. These assessments provided "critical oversight," but they can't be used in place of an actual, in-person inspection.
As the FDA plans for the rest of the year, it's looking at ways to ease the backlog into 2022. Drug applications that have been postponed because of COVID-19 will be "reprioritized" as the FDA plans for fiscal year 2022, the regulator said.
"As we have done throughout the pandemic, FDA will use every option available to meet our regulatory responsibilities and protect the public health," the FDA said.Print
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