Drug Inspector Attrition Leads to 'Many Fewer' Checks Than 2016 Peak, GAO Says

Inspections Down

The number of drug manufacturing inspections conducted by the Food and Drug Administration (FDA) has declined significantly in recent years, according to a new report from the Government Accountability Office (GAO).

The report found that the FDA conducted 2,821 drug manufacturing inspections in fiscal year 2021, down from a peak of 3,414 inspections in fiscal year 2016.

Inadequate Oversight

The GAO report said that the decline in inspections is due to a number of factors, including attrition in the FDA's drug inspector workforce and the agency's increased focus on other priorities, such as the COVID-19 pandemic.

As per GAO, the FDA has acknowledged that the decline in inspections has led to "many fewer" checks on drug manufacturers than in previous years and that this could compromise the safety of the nation's drug supply

Assuring Drug Safety

The FDA is responsible for ensuring the safety of the nation's drug supply.

The agency conducts inspections of drug manufacturing facilities to ensure that they are following good manufacturing practices (GMPs) and that their products are safe and effective.

Impact of Fewer Inspections

The GAO report found that the decline in inspections has had a number of negative consequences, including:

• Increased risk of drug shortages
• Reduced ability to detect and prevent drug safety problems
• Diminished public confidence in the safety of the nation's drug supply

Recommendations

The GAO report made a number of recommendations to the FDA to address the decline in inspections, including:

• Increase funding for the FDA's drug inspector workforce
• Prioritize drug manufacturing inspections
• Improve the FDA's data collection and analysis capabilities

Conclusion

The GAO report's findings are a serious concern and should prompt the FDA to take immediate action to address the decline in drug manufacturing inspections.

The safety of the nation's drug supply depends on the FDA's ability to conduct thorough and timely inspections of drug manufacturing facilities.