Drug development: Pathway for approving antibacterial and antifungal drugs for patients with limited treatment options is infrequently used : report to congressional committees
- Collection:
- Health Policy and Services Research
- Alternate Title(s):
- Pathway for approving antibacterial and antifungal drugs for patients with limited treatment options is infrequently used
- Contributor(s):
- United States. Government Accountability Office, issuing body. United States. Congress, issuing body.
- Publication:
- Washington, DC : United States Government Accountability Office, November 2021
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Drug Development -- legislation & jurisprudence Drug Resistance Government Regulation Legislation, Drug -- organization & administration United States United States. Food and Drug Administration
- Genre(s):
- Technical Report
- Abstract:
- Why GAO did this study. It is estimated that at least 2.8 million antibacterial and antifungal-resistant infections occur each year in the United States, and more than 35,000 people die as a result, according to the Centers for Disease Control and Prevention. The development of new antibacterial and antifungal treatments is one strategy to address the threat of antimicrobial resistance. The 21st Century Cures Act, enacted in 2016, established LPAD to help facilitate the approval of certain antibacterial and antifungal drugs. FDA oversees the approval of such drugs. The 21st Century Cures Act includes a provision for GAO to review and report on FDA’s LPAD activities. This report describes (1) the extent to which LPAD changes FDA’s drug approval process, (2) the extent to which drug developers have sought to use LPAD for drugs under development, and (3) stakeholders’ and FDA’s views on the effectiveness of LPAD in benefiting the development and approval of antibacterial and antifungal drugs. GAO reviewed FDA guidance documents; documentation from the approval process; and drug developers’ written statements to investors and FDA on LPAD. GAO also interviewed FDA officials and obtained information from 10 stakeholders selected because they sought approval for a drug through LPAD, considered using LPAD, or provided written comment to FDA on LPAD. These included two industry associations, one think tank, and seven drug developers. HHS provided technical comments on a draft of this report, which GAO incorporated 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 (ii, 19 pages))
- NLM Unique ID:
- 9918383084806676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918383084806676