Post-Pandemic Struggles: The FDA's Inspection Dilemma

Federal regulators are facing challenges in resuming pre-pandemic levels of drug factory inspections. An analysis reveals that the FDA has not returned to approximately 2,000 pharmaceutical firms since before COVID-19. The backlog is raising concerns about drug safety, with significant delays in overseas inspections, particularly in India and China.

Federal regulators responsible for the safety of the US drug supply are grappling to regain their pre-pandemic momentum, according to an investigation by The Associated Press. Data reveals that the FDA staffers have not revisited around 2,000 pharmaceutical manufacturing facilities for surveillance inspections since before the COVID-19 outbreak.

These overdue inspections constitute about 42% of the 4,700 plants currently registered to produce US drugs. While most of these plants are in the US, over 340 of them are in India and China—key sources of low-cost drug ingredients. The lapse raises concerns about the potential for reduced quality standards amid intense cost-cutting pressures on generic drugmakers.

FDA Associate Commissioner Michael Rogers emphasized that foreign plants have been prioritized in resumed inspections, although the total number of inspections remains down by 40% from pre-pandemic levels. The agency halted most inspections in March 2020 but has since gradually resumed them. However, the inspection backlog continues to disrupt the global drug supply chain, and political challenges in China further complicate the situation.

(With inputs from agencies.)