GAO criticizes FDA's current Inspections Approach

Recommendation

7/8 May 2024

KPIs and Quality Metrics - Live Online Training
How to foster Continual Quality Improvement

In a report published end of January, the U.S. Government Accountability Office (GAO) asks the US Food and Drug Administration (FDA) to review its inspections approach during the pandemic. They also fear an obvious backlog in inspections and that FDA "will face challenges with its drug approval and surveillance activities, particularly given that the alternative tools FDA is using while inspections are postponed are not a long-term or comprehensive substitute".

FDA has limited domestic and foreign inspections for the safety of its employees and started using alternative inspection tools like information from inspections conducted by foreign regulators, paper based inspections, and increased sampling and testing. But this is not a full replacement and FDA "could be faced with a backlog of inspections".

As outlined in the report, the "total number of FDA inspections of foreign and domestic establishments was 56 percent lower in fiscal year 2020 than during each of the previous two fiscal years". Between March and October 2020, FDA conducted only three foreign inspections (in Canada, Germany and India). Normally the agency performs around 600 inspections during this period. And currently it is not clear when FDA will be resuming regular foreign surveillance inspections. At least, according to FDA, "in January 2021, staff in the agency's China office had begun conducting surveillance inspections in China and staff in the agency's India office would begin conducting surveillance inspections in India shortly".

Recommendations made by GAO:

• FDA's future inspection plans should "identify, analyze, and respond to the issues presented by the backlog of inspections that could jeopardize its goal of risk-driven inspections"
• FDA should assess "alternative inspection tools and consider whether these tools or others could provide the information needed to supplement regular inspection activities or help meet the agency's drug oversight objectives when inspections are not possible in the future"

Source: COVID-19: Critical Vaccine Distribution, Supply Chain, Program Integrity, and Other Challenges Require Focused Federal Attention - Report to Congressional Committees