Federal regulators are grappling with a significant backlog of factory inspections for drug manufacturing, with many facilities not reviewed since before the pandemic.
An analysis by The Associated Press of FDA data revealed that approximately 42% of the 4,700 registered plants have not undergone FDA surveillance inspections since 2019.
These facilities produce crucial medicines such as antibiotics, blood thinners, and cancer therapies, raising concerns over potential contamination and quality issues.
An AP analysis reveals that approximately 2,000 pharmaceutical manufacturers have not undergone FDA surveillance inspections since before the pandemic. This oversight raises potential contamination risks and other safety issues in medications.
A scholar from Duke University expressed concerns about generic drugmakers reducing costs at the expense of quality, which remains unchecked without proper inspections in an ABC News report.
Tainted medications, like the 2022 incident involving antibiotic-resistant bacteria in eyedrops from an Indian factory, underscore the risks of insufficient oversight.
These factories, particularly in India and China, are critical suppliers of low-cost prescription ingredients in the U.S.
Despite the challenges, FDA Associate Commissioner Michael Rogers asserted that the FDA is the world's most stringent drug regulator. However, he acknowledged that inspection rates are still nearly 40% lower than pre-COVID levels, with no set timeline for clearing the backlog.
The situation is exacerbated by staffing challenges, with many experienced inspectors leaving for more flexible job opportunities.
Internationally, the FDA has been using video and online tools for preliminary assessments, but these do not substitute for physical inspections.
The Government Accountability Office has consistently marked this area as high-risk, signaling that more proactive measures are necessary. In the meantime, the FDA focuses on a risk-based approach to prioritize inspections that pose the greatest public health risk.
