Drug safety: preliminary findings indicate persistent challenges with FDA foreign inspections : testimony before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, House of Representatives

Drug safety: preliminary findings indicate persistent challenges with FDA foreign inspections : testimony before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, House of Representatives

Collection:
Health Policy and Services Research
Contributor(s):
United States. Government Accountability Office, issuing body.
United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations, issuing body.
Publication:
Washington, DC : United States Government Accountability Office, December 10, 2019
Language(s):
English
Format:
Text
Subject(s):
Drug Industry -- legislation & jurisprudence
Government Regulation
Pharmaceutical Preparations -- standards
United States
United States. Food and Drug Administration
Genre(s):
Technical Report
Abstract:
Why GAO did this study. More than 60 percent of establishments manufacturing drugs for the U.S. market were located overseas in fiscal year 2018. FDA has estimated that about 40 percent of finished drugs and 80 percent of active drug ingredients are manufactured overseas. FDA is responsible for overseeing the safety and effectiveness of all drugs marketed in the United States, regardless of where they are produced and conducts inspections of both foreign and domestic drug manufacturing establishments. GAO has had long-standing concerns about FDA’s ability to oversee the increasingly global supply chain, an issue highlighted in GAO’s High Risk Series for the last 10 years. GAO recommended in 2008 (GAO-08-970) that FDA increase the number of inspections of foreign drug establishments. GAO found in 2010 (GAO-10-961) and 2016 (GAO-17-143) that FDA was conducting more of these foreign drug inspections, but GAO also reported that FDA may have never inspected many establishments manufacturing drugs for the U.S. market. This statement is based on ongoing work and provides preliminary GAO observations on 1) the number of foreign inspections FDA has conducted, 2) inspection staffing levels, and 3) challenges unique to foreign inspections. For this work, GAO examined FDA data, visited FDA foreign offices in China and India, and interviewed drug investigators based in these offices and in the United States. What GAO recommends. GAO will continue to assess these issues as part of ongoing work, and make recommendations as appropriate.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (28 pages, 1 unnumbered page))
Illustrations:
Illustrations
NLM Unique ID:
9918284259106676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918284259106676