Just as the U.S. hoped to turn the page on COVID-19, the omicron variant touched down, sending case counts to record levels and reigniting debate over social distancing measures. The FDA, which has accrued a hefty backlog of manufacturing inspections over the past two years, isn’t immune to the latest variant concerns, either.
Now, shortly after the FDA said it was getting a handle on pandemic-era oversight at home, omicron has forced the agency to pause its work yet again.
The FDA has put certain inspection operations on hold through Jan. 19 as it works “to ensure the safety of its employees and those of the firms it regulates” in the face of omicron. The pause began last Wednesday, shortly before the New Year, and will last for at least two more weeks, the regulator said Tuesday. Over that stretch, the FDA plans to continue work deemed “mission-critical,” with the goal to restart paused inspections “as soon as possible.”
The FDA will strive to continue foreign mission-critical inspections, too, though the latest pause has put a damper on plans to overhaul its larger oversight mission abroad—an effort that was scheduled to kick off in February. Now, the agency says it will have to postpone planning for foreign surveillance inspection assignments.
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Meanwhile, as it has throughout the pandemic, the FDA says it’s “leveraging other remote tools to maintain oversight of foods, drugs, medical products and tobacco.”
After pausing inspection work in early 2020, the FDA largely returned to “standard operations for domestic inspections” in July 2021, then-acting FDA commissioner Janet Woodcock said that month. By November, the regulator said it had wrapped up 1,139 domestic inspections out of 3,229 outstanding for medical products and devices.
In doing so, the FDA exceeded its goal for U.S. inspections that it laid out in its May 2021 “roadmap” for inspectional resiliency, Judy McMeekin, associate commissioner for regulatory affairs at the FDA, said in a recent interview.
Prior to the latest pause, it seemed possible that the FDA could complete its backlog of domestic drug plant inspections in 2022. That said, the problems facing the FDA abroad run deeper than COVID-19 and are unlikely to be resolved before the year is out, Mary Denigan-Macauley, director of healthcare at the Government Accountability Office (GAO), recently told Fierce Pharma.
Overseas staffing vacancies and language barriers pose two big problems for foreign inspections, Denigan-Macauley explained. The FDA’s McMeekin said the regulator is “actively working on these issues,” pointing to a pilot program the FDA planned to debut in 2022 that would endeavor to “enhance translator capabilities of foreign drug inspections.”
McMeekin also addressed staffing concerns, noting that the agency is actively hunting for “foreign cadre staff”—agency officials who would be based in the U.S. but travel to foreign countries to conduct inspections.
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Between April and September of 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.
Meanwhile, in its mid-November oversight update, the FDA reported 52 new drug application delays because of the agency’s pandemic-related inspection backlog, up from 48 delayed applications reported in May.
The omicron-prompted pause doesn’t come as a “huge surprise given the significant increase in cases globally,” Wells Fargo analysts wrote in a note to clients Wednesday. It does, however, pose a “potential problem to timing for certain approvals (and/or re-submissions) for a number of therapeutic companies,” the team said.
Much of the concern around the FDA's backlog has focused on delays in new drug approvals, but it also presents a problem for companies that have received write-ups from the regulator. Those firms depend on FDA inspections to clear warning letters or import alerts.
As for alternative oversight tools, the agency has relied upon remote inspections to supplement its work, but remote reviews don’t satisfy the in-person requirements for surveillance inspections. By turning to digital, the FDA could make a dent in the number of user fee delays it clears, but it will still be saddled with hundreds of surveillance inspections that require an in-person touch.
"We learned through our own experiences thus far and in discussing remote assessment approaches with our foreign counterparts, that remote assessments have presented meaningful technical challenges and require more resources than anticipated," FDA's McMeekin noted.