In 2019, the FDA began to increase the number of inspections of foreign drug manufacturing establishments after decreases from fiscal years 2016 through 2018. However, beginning in March 2020, the FDA postponed most inspections because of the COVID-19 pandemic, conducting three foreign inspections from March to October 1, 2020. In comparison, FDA conducted more than 600 foreign inspections over the same time period in each of the two prior years.
The GAO recognizes the FDA faces unique challenges conducting foreign inspections—including inspections have generally been pre-announced, and investigators may rely on the establishment being inspected to provide translation services. While drugs manufactured overseas for the U.S. market must meet the same requirements as those manufactured in the U.S., these unique challenges raise questions about the equivalence of foreign to domestic inspections.
 | Cold Chain Logistics: Poised for Growth with Lessons Learned fro the Pandemic |
As a result of the COVID-19 pandemic and the reduction in inspections, the GAO was asked to update its previous work on the FDA’s foreign drug inspection program. According to the resulting report, the GAO is making three recommendations that the FDA Commissioner should ensure the agency:
- Incorporates leading practices the GAO identified for designing a well-developed, documented pilot program as it finalizes its plans for implementing a pilot program to evaluate the effectiveness and efficiency of unannounced foreign inspections
- Incorporates leading practices the GAO identified for designing a well-developed, documented pilot program as it finalizes its plans for implementing a pilot program to evaluate the costs and effects of using different types of translation services during foreign inspections
- Fully develops tailored strategies—including detailing implementation steps and time frames—focused on recruiting new and developing and retaining current investigators to specialize in conducting foreign drug inspections
