FDA's Foreign Inspections of Drug Manufacturers Have Not Rebounded to Pre-Pandemic Levels
Introduction
The Food and Drug Administration (FDA) is responsible for ensuring the safety and efficacy of drugs sold in the United States. As part of this responsibility, the FDA conducts inspections of drug manufacturers both in the US and abroad.
The COVID-19 pandemic has had a significant impact on the FDA's ability to conduct foreign inspections. In 2020, the FDA conducted only 225 foreign inspections, down from 557 in 2019. In 2021, the number of foreign inspections rebounded to 327, but this is still below pre-pandemic levels.
The Impact of Reduced Foreign Inspections
The reduction in foreign inspections has had a number of consequences, including:
- Increased risk of drug shortages
- Delays in the approval of new drugs
- Reduced ability to ensure the safety and efficacy of drugs
Drug shortages can occur when there is a disruption in the supply of a drug. This can be caused by a number of factors, including manufacturing problems, quality control issues, and natural disasters.
Delays in the approval of new drugs can occur when the FDA is unable to conduct the necessary inspections to ensure the safety and efficacy of the drug. This can lead to delays in the availability of new treatments for patients.
Reduced ability to ensure the safety and efficacy of drugs can occur when the FDA is unable to conduct the necessary inspections to verify that drugs are being manufactured in accordance with good manufacturing practices (GMPs). This can lead to the release of unsafe or ineffective drugs into the market.
The FDA's Response
The FDA is aware of the impact that the reduction in foreign inspections has had on the safety and efficacy of drugs. The agency is taking a number of steps to address this issue, including:
- Increasing the number of foreign inspections
- Developing new inspection protocols
- Working with foreign regulators to improve the quality of inspections
The FDA is also working to develop new technologies to improve the efficiency of inspections. These technologies include the use of virtual reality and augmented reality to conduct remote inspections.
Conclusion
The FDA's foreign inspections of drug manufacturers have not rebounded to pre-pandemic levels. This has had a number of consequences, including increased risk of drug shortages, delays in the approval of new drugs, and reduced ability to ensure the safety and efficacy of drugs.
The FDA is taking a number of steps to address this issue, but it is unclear how long it will take for the agency to return to pre-pandemic inspection levels.
