ABSTRACT

Drug Safety: COVID-19 Complicates Already Challenged FDA Foreign Inspection Program, Statement of Mary Denigan-Macauley, Director, Health Care, Testimony Before the Committee on Finance, U.S. Senate   [open pdf - 876KB]

From the GAO [Government Accountability Office] Highlights: "The outbreak of COVID-19 [coronavirus disease 2019] has called greater attention to the United States' reliance on foreign drug manufacturers and further highlighted the importance of ensuring a safe pharmaceutical supply chain. Much of the manufacturing of drugs for treating COVID-19 occurs overseas, which is also true of the majority of other drugs marketed in the United States. While the volume of drugs manufactured overseas for the U.S. market is not fully known, FDA [Food and Drug Administration] reports that about 70 percent of establishments manufacturing active ingredients and more than 50 percent of establishments manufacturing finished drugs for the U.S. market were located overseas, as of August 2019."

Report Number:
GAO-20-626T
Author:
Publisher:
Date:
2020-06-02
Series:
Copyright:
Public Domain
Retrieved From:
Government Accountability Office: https://www.gao.gov/
Format:
pdf
Media Type:
application/pdf
URL:
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