Drug safety: COVID-19 complicates already challenged FDA foreign inspection program : testimony before the Committee on Finance, U.S. Senate
- Collection:
- Health Policy and Services Research
- Contributor(s):
- United States. Government Accountability Office, issuing body. United States. Congress. Senate. Committee on Finance, issuing body.
- Publication:
- Washington, DC : United States Government Accountability Office, June 2, 2020
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Pharmaceutical Preparations -- supply & distribution Drug Contamination -- legislation & jurisprudence Government Regulation Legislation, Drug United States United States. Food and Drug Administration
- Genre(s):
- Technical Report
- Abstract:
- Why GAO did this study. The outbreak of COVID-19 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 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. 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 pharmaceutical supply chain, an issue highlighted in GAO’s High Risk Series since 2009. In particular: (1) GAO recommended in 2008 (GAO-08-970) that FDA increase the number of inspections of foreign drug establishments. (2) GAO found in 2010 (GAO-10-961) that FDA continued to conduct relatively few foreign inspections than domestic inspections. GAO found in 2016 (GAO-17-143) that FDA was conducting more of these foreign drug inspections, and GAO closed its 2008 recommendation to conduct more foreign inspections. However, GAO also reported that FDA may have never inspected many foreign establishments manufacturing drugs for the U.S. market. In addition, in the summer of 2018, FDA began announcing recalls of blood pressure medications manufactured overseas that were tainted with a potential carcinogen, raising further questions about FDA’s oversight of foreign-manufactured drugs. This statement is largely based on GAO’s December 2019 testimony (GAO-20-262T) and discusses: (1) the number of foreign inspections FDA has conducted, (2) inspection staffing levels, and (3) challenges unique to foreign inspections. For that testimony, GAO examined FDA data from fiscal years 2012 through 2018 and interviewed investigators from FDA’s 2019 cadre of investigators (who are based in the United States but exclusively conduct foreign drug inspections) and from FDA’s foreign offices in China and India.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (26 pages))
- Illustrations:
- Illustrations
- NLM Unique ID:
- 9918250409406676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918250409406676