Drug safety: FDA should take additional steps to improve its foreign inspection program : report to congressional requesters
- Collection:
- Health Policy and Services Research
- Contributor(s):
- United States. Government Accountability Office, issuing body. United States. Congress, issuing body.
- Publication:
- Washington, DC : United States Government Accountability Office, January 2022
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Drug and Narcotic Control -- organization & administration Government Regulation Pharmaceutical Preparations -- supply & distribution United States Food and Drug Administration -- organization & administration United States
- Genre(s):
- Technical Report
- Abstract:
- Why GAO did this study. 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—have complicated FDA's oversight of the more than 4,000 establishments manufacturing drugs for the U.S. HHS 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 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. For this work, GAO examined FDA data and documents and interviewed drug investigators and other FDA officials. GAO also visited FDA foreign offices in China and India in fall 2019. What GAO Recommends. GAO is making three recommendations: that FDA incorporate leading practices into the design of both its unannounced inspection and translation pilot programs and fully develop tailored strategies to ensure it has a sufficient foreign inspection workforce. HHS agreed with GAO’s recommendations.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (iii, 61 pages))
- Illustrations:
- Illustrations
- NLM Unique ID:
- 9918383088706676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918383088706676