Drug Safety: Improving FDA's Foreign Inspection Program - Director Summary

Mary Denigan-Macauley discusses our February 2022 report on the Federal Drug Administration's foreign drug inspection program. The COVID-19 pandemic postponed the majority of the foreign inspections FDA had planned to conduct in 2020 and 2021, resulting in a backlog that could make it more difficult for the agency to ensure the safety and effectiveness of these drugs. We recommended that FDA develop tailored strategies and time frames to recruit and retain investigators for its foreign inspection workforce, which could help address a backlog of inspections.