FDA Global Drug Inspections: Surveillance Of Manufacturing Establishments Remains Well Below Pre-COVID-19 Levels.

Abstract

During the initial phase of the COVID-19 pandemic, the Food and Drug Administration (FDA) halted inspections of most overseas drug manufacturing establishments. Looking at data from the period 2012-22, we observed steep declines in both foreign and domestic inspections in 2020. By 2022, numbers of inspections remained well below prepandemic levels, with a 79percent decrease in foreign inspections and a 35percent decline in domestic inspections compared with 2019. There was no corresponding reduction in drug manufacturing or imports. Also, the resources allocated per inspection surged, although the FDA's overall budget and staffing remained steady. Finally, citations rose dramatically, despite all establishments being given advance notice of inspections. The findings of our study underscore the pressing need to explore alternative methods for ensuring drug safety.