FDA Faces Challenges in Catching Up on Drug Facility Inspections
WASHINGTON — As the COVID-19 pandemic began in early 2020, the Food and Drug Administration (FDA) withdrew many of its safety inspectors from the field, resulting in a significant backlog of pharmaceutical plant inspections both in the U.S. and overseas.
Nearly five years later, the FDA’s effectiveness in addressing this backlog and ensuring the safety of drug manufacturing facilities is under scrutiny. The FDA maintains a list of drug facilities to inspect annually, prioritizing based on potential risks, yet this list remains confidential.
Reports indicate that approximately 42% of drug plants that should have been inspected have not undergone a follow-up since May 2019. These facilities produce essential medications, including antibiotics, blood thinners, and cancer treatments.
The FDA’s own regulations classify factories that have gone uninspected for five or more years as significant risks and mandate their prioritization for inspections. A concerning number of these overdue facilities, over 340, are located in India and China, key suppliers of generic drug ingredients for U.S. prescriptions.
FDA officials assert that the U.S. drug supply is among the safest globally. However, they emphasize that the agency must prioritize inspections based on public risk levels. To enhance their efforts, officials are leveraging online tools and data from international regulators.
Although inspections have increased since 2021, focusing particularly on overseas plants, the FDA’s inspection rates have not returned to pre-pandemic levels. Recent statistics reveal a 40% decrease in inspections compared to before COVID-19.
According to FDA officials, attrition has been a significant impediment to efficient operations. A considerable number of departures, both during and after the pandemic, have left the agency with a less experienced workforce. “We aren’t able to keep up with the pace of attrition,” noted an FDA associate commissioner, emphasizing ongoing training efforts for new inspectors.
Currently, over 220 positions remain unfilled within the FDA’s inspection team. Presently, the workforce is just 85% staffed, a decline from over 95% in fiscal 2019, which poses further challenges to their inspection capabilities.
Inspections that do occur, particularly those in India and elsewhere, often reveal severe compliance violations. For instance, during a recent visit to Intas Pharmaceuticals in India, an FDA inspector observed a worker discarding critical drug testing documentation. This plant has faced multiple warnings for inadequate manufacturing practices and recordkeeping.
