FDA struggles with inspection backlog of pharmaceutical plants post-COVID

Federal regulators are facing significant challenges in addressing a backlog of pharmaceutical plant inspections that accumulated during the COVID-19 pandemic. As of now, approximately 42% of the 4,700 registered drug production facilities in the U.S. are overdue for safety and quality inspections. This situation is particularly concerning as many of these plants are located in India and China, which are major sources of drug ingredients for the U.S. market. The lack of inspections raises serious safety concerns, as evidenced by a recent outbreak linked to tainted eyedrops from an Indian factory that resulted in multiple illnesses and fatalities. The FDA has acknowledged the difficulties in maintaining its inspection workforce, with 225 vacancies reported, nearly quadruple the number before the pandemic. The agency is struggling to retain inspectors who often find more lucrative opportunities in the private sector. This has led to a significant increase in the number of overdue inspections, particularly in India, where 11% of plants have been cited for violations. In response to the growing backlog, the FDA is exploring strategies to make inspection roles more appealing, such as offering additional pay and improved travel arrangements. However, the agency's reliance on international partners for inspection data complicates the situation, as it may not provide a complete picture of the safety and quality of imported drugs. The ongoing inspection backlog has drawn scrutiny from lawmakers and raised questions about the effectiveness of the FDA's current approach to ensuring drug safety. As the agency works to adapt to the new realities post-COVID, the health and safety of the U.S. drug supply remain at risk.