ABSTRACT

Drug Safety: FDA Should Take Additional Steps to Improve Its Foreign Inspection Program, Report to Congressional Requesters   [open pdf - 5MB]

From the Highlights: "FDA is responsible for ensuring the safety and effectiveness of all drugs marketed in the U.S., regardless of where they are produced. Globalization--and the outbreak of COVID-19 [coronavirus disease 2019]--have complicated FDA's oversight of the more than 4,000 establishments manufacturing drugs for the U.S. HHS [Department of Health and Human Services] reported that 73 percent of establishments manufacturing active ingredients, and 52 percent of those manufacturing finished drugs for the U.S., were located overseas as of March 2021. GAO's [Government Accountability Office] concerns about FDA's ability to oversee the increasingly global drug supply chain led it to designate the issue as a high risk area in 2009. GAO was asked to update its work on FDA's foreign drug inspection program. This report (1) describes the number of inspections prior to and during the COVID-19 pandemic, (2) examines steps taken to address challenges related to preannouncing foreign inspections and language barriers, and (3) examines efforts to maintain a sufficient inspection workforce, among other objectives."

Report Number:
GAO-22-103611
Publisher:
Date:
2022-01
Series:
Copyright:
Public Domain
Retrieved From:
Government Accountability Office: http://www.gao.gov/
Format:
pdf
Media Type:
application/pdf
URL:
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