The Food and Drug Administration (FDA) is grappling with a significant backlog in factory inspections, struggling to return to pre-pandemic levels.
An analysis by The Associated Press reveals that approximately 2,000 pharmaceutical manufacturing facilities, representing 42% of the plants previously inspected before May 2019, remain overdue for follow-up inspections. This backlog poses potential risks for drug safety and quality.
The plants in question produce critical medications, including antibiotics, blood thinners, and cancer therapies. The delay in inspections has raised concerns about contamination and other quality issues. While the FDA has prioritized inspections of facilities that have not been inspected in over five years, many facilities—particularly in India and China—are still awaiting review.
David Ridley, a pharmaceutical industry expert at Duke University, emphasized the importance of inspections in maintaining drug quality.
“Generic drugmakers are under intense pressure to cut their costs, and some may do so by compromising quality… Without inspections, these issues might not be detected until it’s too late,” he said.
Last year, a significant incident highlighted the risks of inadequate inspections: tainted eyedrops from an Indian factory led to an outbreak of antibiotic-resistant bacteria, resulting in severe health consequences for several Americans. This factory was not registered with the FDA.
Despite an increase in inspections since 2021, the FDA’s inspection numbers were still nearly 40% below pre-pandemic levels in 2023. FDA Associate Commissioner Michael Rogers attributed the challenges to a wave of staff departures and increased workloads.
“The loss of experienced investigators is a significant challenge… We are working to retain our staff and address this backlog,” Rogers said.
The FDA halted most inspections in March 2020, resuming only critical inspections later that year and regular international visits in 2022. Although the agency has used remote tools like video inspections during the pandemic, these do not fully replace in-person evaluations.
The backlog has been exacerbated by a high turnover rate among FDA inspectors, with current vacancies numbering 225—nearly four times the pre-pandemic level. The agency faces difficulties in retaining staff who are often lured by higher salaries and better working conditions in the private sector.
Former FDA inspector Jose Hernandez highlighted the challenges of the job, noting the demanding travel and reporting requirements.
“Inspectors can earn significantly more working for industry than they do at the FDA,” Hernandez said.
The backlog also impacts the FDA’s ability to oversee drug manufacturing globally. In India, where 160 plants are overdue for inspection, the FDA has found significant violations, such as the destruction of drug testing documents. In China, political tensions have further complicated inspections.
To address the issue, the FDA is exploring various measures, including improving working conditions for inspectors and considering alternative approaches to monitoring drug quality. A pilot program by the US Defense Department, in collaboration with a private lab, is testing critical drugs for contaminants and quality, providing additional oversight.
Experts suggest that this situation may prompt broader changes in how drug quality is monitored and regulated.
“This might lead to a reevaluation of how we approach global drug manufacturing and regulation,” said Dr. Kevin Schulman from Stanford University.
