Drug manufacturing: FDA should fully assess its efforts to encourage innovation : report to congressional committees
- Collection:
- Health Policy and Services Research
- Alternate Title(s):
- FDA should fully assess its efforts to encourage innovation: report to congressional committees
- Contributor(s):
- United States. Government Accountability Office, issuing body.
- Publication:
- Washington, DC : United States Government Accountability Office, March 2023
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Civil Defense -- legislation & jurisprudence Drug Industry -- legislation & jurisprudence Government Regulation Legislation, Medical Pharmaceutical Preparations -- supply & distribution Public Health -- legislation & jurisprudence United States United States. Food and Drug Administration
- Genre(s):
- Technical Report
- Abstract:
- Why GAO did this study. FDA, a component agency within the Department of Health and Human Services’ (HHS), is responsible for ensuring that drugs marketed in the U.S. are safe and effective. The agency also plays a role in supporting manufacturing innovation. GAO has previously reported on challenges FDA has faced in its oversight of the drug supply chain and deficiencies in FDA and other HHS entities’ preparation for and response to public health emergencies. As such, GAO has designated both as high-risk areas. The CARES Act includes a provision for GAO to report on the federal pandemic response. This report (1) examines FDA’s efforts to support advanced manufacturing, including in response to the COVID-19 pandemic. In addition, it (2) describes stakeholders’ perspectives on the regulatory challenges to increasing the use of advanced manufacturing for drugs and (3) describes FDA actions to address challenges to increasing the use of advanced manufacturing. For this work, GAO reviewed FDA documents, national supply chain resiliency strategies, and interviewed FDA and 15 drug industry stakeholders, including companies with approved drugs and those seeking approval. What GAO recommends. GAO is recommending that FDA document and finalize performance goals and measures related to its advanced manufacturing program efforts and regularly assess program progress. HHS concurred with this recommendation.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (ii, 38 pages))
- Illustrations:
- Illustrations
- NLM Unique ID:
- 9918627774906676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918627774906676