Inspections: GAO calls on FDA to plan for backlog, review alternatives

In a recent report to Congress on the federal government’s COVID-19 response, the Government Accountability Office (GAO) asked FDA to review its inspections approach and form a plan to address its emerging backlog. Early on in the pandemic, FDA stopped non-mission-critical foreign and domestic inspections and relied on alternative tools, such as inspection reports, to complement its oversight activities. Last year, the agency conducted less than half as many drug establishment inspections compared with the previous 2 fiscal years. According to GAO, the decline in inspections adds to its “long-standing concerns about FDA’s ability to oversee drugs manufactured overseas.” GAO found that from March, when FDA halted most foreign inspections, to September, the agency conducted just three “mission critical” foreign inspections. FDA also conducted just 52 domestic inspections during that period, compared with about 400 in that time in each of the prior 2 years. The report notes that FDA’s ability to rely on inspections carried out by its overseas counterparts may be limited going forward, as other regulators have also postponed inspections during the pandemic.