FDA inspections restarted earlier this month in the United States, finally giving the regulator a chance to work through the enormous domestic backlog which accumulated during the coronavirus pandemic.
But what about foreign inspections?
That’s a question that concerns members of the House Energy & Commerce Committee, who sent a letter to acting FDA Secretary Janet Woodcock with questions over how the agency can ensure the safety and quality of drugs that arrive from outside the country.
When the pandemic hit, the FDA prioritized inspections and conducted only those it deemed mission critical. From March to October of last year, the FDA performed only three inspections overseas, the Government Accountability Office said. Over that span in a typical year, the FDA would conduct 600 inspections of foreign facilities, the report said.
During an agency education conference last week, Woodcock said that foreign inspections still were being “prioritized,” sparking the interest of Congress.
“We remain concerned that more than one year into the pandemic, the strategy for resuming all inspections and addressing the backlog of delayed inspections remains unclear,” the lawmakers wrote.
Congress has given the FDA until Aug. 5 to answer several questions, including when the agency will resume normal operations for foreign inspections and whether it has determined the impact of inspection delays on potential drug approvals.
Congress also wants the FDA to explain how its Center for Drug Evaluation and Research is using a $38.3 million government grant, it received as part of the American Rescue Plan, to prepare for the resumption of foreign inspections.
In addition, lawmakers want the FDA to explain its plan to resume unannounced inspections in light of its revelation in March that it was pre-announcing all inspections because of the pandemic.
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The letter also asks the FDA to estimate how long it will take to eliminate the inspection backlog and how it can improve its remote inspections as part of its plan to modernize data platforms and infrastructure.
Congressional scrutiny of FDA inspections has ramped up with recent manufacturing problems exposed during the pandemic, especially those at an Emergent plant in Baltimore which forced the disposal of millions of doses of COVID-19 vaccines.
Back in May, the FDA said thousands of plant inspections had piled up in its backlog because of COVID-19 restrictions. Most of them were for food plants, but hundreds are for drug facilities.