The Government Accountability Office (GAO) recently delivered testimony maintaining the lack of foreign drug manufacturer inspections removes critical information about the quality of drugs manufactured for markets here.
The GAO said the Food and Drug Administration (FDA) began postponing almost all foreign manufacturing establishment inspections in March 2020 in the wake of the COVID-19 pandemic, adding a growing number of foreign drug manufacturing inspections conducted by the FDA were in China and India, where most establishments that manufacture drugs for the United States were located.
The GAO said while the FDA has indicated it has other tools at its disposal to ensure the safety of the nation’s drug supply, the lack of foreign inspections creates an information void about manufacturing.
According to the GAO, the agency has had long-standing concerns with the FDA’s ability to oversee the advancing global pharmaceutical supply chain, which has been highlighted in GAO’s High Risk Series since 2009.
The GAO indicated while FDA inspections performed in the United States were almost always unannounced, the FDA’s practice of pre-announcing foreign inspections up to 12 weeks in advance may have presented manufacturers the opportunity to address problems ahead of the inspection.
Additionally, the GAO determined the FDA was not generally providing translators on foreign inspections, instead relying on translators provided by the foreign establishments being inspected, which the GAO said raised questions about the accuracy of information FDA investigators collected – citing there was more risk of conflict of interest if the establishment used its own employees to translate.