Drug Safety: FDA's Future Inspection Plans Need to Address Issues Presented by Covid-19 Backlog, Statement of Mary Denigan-Macauley, Director, Health Care, Testimony Before the Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, Committee on Appropriations, House of Representatives   [open pdf - 898KB]

From the Highlights: "The outbreak of COVID-19 [coronavirus disease 2019] has called greater attention to the United States' reliance on foreign drug manufacturers. FDA reports that 74 percent of establishments manufacturing active ingredients and 54 percent of establishments manufacturing finished drugs for the U.S. market were located overseas, as of May 2020. FDA is responsible for overseeing the safety and effectiveness of all drugs marketed in the United States, regardless of where they are produced, and it conducts inspections of both foreign and domestic manufacturing establishments. GAO [Government Accountability Office] has had long-standing concerns about FDA's ability to oversee the increasingly global pharmaceutical supply chain, an issue highlighted in GAO's High Risk Series since 2009. This statement is largely based on GAO's Drug Manufacturing Inspections enclosure in its January 2021 CARES [Coronavirus Aid, Relief, and Economic Security] Act report, as well as GAO's December 2019 and June 2020 testimonies. Specifically, it discusses (1) the number of FDA's foreign inspections, (2) FDA's response to the COVID-19 pandemic pause in inspections, and (3) persistent foreign inspection challenges. For that work, GAO examined FDA data from fiscal years 2012 through 2020, interviewed FDA investigators, and reviewed documents related to drug oversight during the COVID-19 pandemic, among other things."

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Government Accountability Office: https://www.gao.gov/
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