FDA inspections declined since pandemic, new study finds

FDA inspections of drug manufacturing facilities in the United States and overseas declined well below pre-pandemic levels between 2020 and 2022, according to a new study in Health Affairs.

The findings are further evidence of a fragile global supply chain at a time when some critical medicines are in short supply. Some shortages were due to inspections that took facilities abroad offline due to safety concerns.

Early in the pandemic, FDA said it would curtail many of its inspections, but work picked back up by July 2020. However, the agency did not resume nonprioritized domestic inspections and foreign inspections that were not mission-critical until last year.

“As the world moves beyond the pandemic, it is crucial for FDA to address the backlog of inspections and to consider new approaches for the future,” wrote the authors of the study, which found a 79% drop in inspections of foreign facilities and a 35% decline in inspections of domestic facilities in 2022 compared with 2019.

“Notably, FDA conducted no inspections in China or India between April 2020 and March 2021,” the authors of the study wrote.

The researchers found no corresponding reduction in drug manufacturing or imports. The study also found citations rose dramatically.