The FDA’s audits or inspections of manufacturing facilities are critical to ensuring the availability of high-quality regulated products to US consumers. The Government Accountability Office (GAO) has raised issues with FDA auditing practices over the years. GAO’s latest report highlights a practical reason that may be affecting FDA audits: the cadre of its inspectors.
FDA employs about 230 dedicated auditors to inspect manufacturing sites worldwide. More than half of the inspections by the FDA inspectors are conducted outside the US. During the pandemic, the foreign audits by the FDA dropped by more than 2 fold due to travel restrictions. Since then the number of inspections has reached the pre-pandemic levels with a caveat; the FDA has about 15% fewer auditors than it had in 2019. There are several reasons why inspectors are a tough job to hire for the FDA. An inspector may need to travel up to 75 of the time with a heavy workload of conducting the audit and writing detailed reports for the audit. The inspectors often face challenges with work-life balance leading to rapid burnout. The pay for the inspectors is similar to that for other jobs within the FDA making it not as attractive a position to start with, and the high turnover means that there isn’t enough time to give proper training to the inspectors.
Although the FDA has explored potential solutions, such as reducing travel expectations or temporarily reassigning investigators to non-travel roles, no formal action plans have been developed. The main reason is that the FDA is already unable to meet all its inspection targets leaving little room to reduce the inspectors’ workload or travel. In the past, the GAO has criticized the FDA for reducing on-site inspections by increasing remote inspections. The FDA has discussed limiting annual foreign travel or reassigning investigators, these options remain theoretical due to their potential to disrupt current inspection schedules.
To address specific travel and workload concerns, the Office of Regulatory Affairs (ORA) has collaborated with FDA stakeholders to identify alternative strategies, such as optimizing travel planning to minimize stress. However, these measures do not resolve the fundamental issues of excessive travel or its impact on work-life balance. Moreover, these strategies are still under development and lack actionable implementation plans. Leadership across ORA, CDER, and the FDA is working to enhance inspection capacity through initiatives like transferring certain preapproval inspections from ORA to CDER. While this could reduce ORA’s overall workload, it does not alleviate the travel and inspection burden for individual investigators, as they are still required to meet other inspection goals, such as those for surveillance inspections. The GAO recommends that the FDA hire more inspectors which would require additional funding and senior investigators for training—a challenge given FDA’s current resource constraints.
There is no obvious and easy solution to this conundrum, under the current policies which require the FDA to primarily trust internal resources for regulatory oversight. Regulators in other countries do not have similar issues. Worldwide regulators have harmonized inspections by relying on organizations like the PICS whereby regulators share resources and trust each other’s findings. Although the FDA is a member of PICS, it does not use it to the same level as its counterparts in other countries. Perhaps it is time for a new plan.
