Forced by COVID-19 to suspend or adjust business as usual, the FDA accrued a massive backlog of facility inspections in 2020. Now, the agency is laying the groundwork to get its site reviews back on track.
Between March 2020 and March 2021, the FDA conducted a total of 821 “mission critical” inspections and 777 priority domestic inspections, the regulator said in a recent report on its pandemic-era oversight. Now, to catch up on last year’s backlog, the FDA says it needs to complete 26,250 site inspections in the fiscal year ending September 30. Most of the outstanding site inspections are for food producers.
“[T]here is no doubt that the pandemic has had an impact on our inspectional work,” Janet Woodcock, M.D., acting commissioner of the FDA, said in a newly released "resiliency roadmap."
Of the 26,250 inspections needed for its fiscal year 2021, the agency says it has completed nearly 3,000 as of March. The agency plans to tap international partners for help, but "if the agency’s partners are unable to conduct these inspections, FDA will be responsible for carrying them out," the document says. More than 15,500 sites are for food producers that need to be inspected every so often by law.
"Given the large number of outstanding inspections, prioritization will need to occur," the agency said in the document.
Aside from staring down a huge backlog, the agency acknowledges the pandemic could still disrupt its plans. Moving forward, the work will be "largely dependent on the course of the COVID-19 pandemic," the road map says.
The FDA last March decided to temporarily pause foreign and domestic inspections, save for those it deemed mission-critical. That distinction covers COVID-19-related products, breakthrough therapies, products used to treat serious diseases where there's no substitute, and products that require a follow-up because of recalls or other safety issues, the regulator said.
After developing a system to track the virus' trajectory state-to-state, the agency resumed certain U.S. inspections in July.
The new road map outlines a variety of scenarios for this year. Depending on the outcome of the pandemic, the FDA sees the remainder of 2021 playing out in one of three ways: Its "base-case" assumes the regulator will be able to complete 851, or 26%, of the 3,229 domestic inspections for human and animal drug products on the docket. In the best of all possible worlds, the regulator says it could knock out about half of those inspections this year.
But if things go sideways, and the pandemic continues to create barriers, the agency says it "would focus on oversight work most critical to its mission and limit inspection activities." In that scenario, it'd continue to use alternative oversight tools such as remote inspections and document requests.