Government Accountability Office: Drug Safety: COVID-19 Complicates Already Challenged FDA Foreign Inspection Program
“The outbreak of COVID-19 has called greater attention to the United States’ reliance on foreign drug manufacturers. Much of the drug manufacturing for the U.S. market happens overseas — and drugs for treating COVID-19 are no exception. Food and Drug Administration inspections of foreign and domestic drug manufacturers are critical to ensuring drug safety and effectiveness. But FDA began to postpone almost all inspections of foreign manufacturing establishments in March 2020 due to COVID-19. We testified that this lack of foreign inspections removes a critical source of information about the quality of drugs manufactured for the U.S. market…” (6/2).