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# LPAD Pathway Rarely Used: GAO Analysis
- URL: https://www.fdaweb.com/lpad-pathway-rarely-used-gao-analysis/
- Published: 2021-11-23T12:00:00.000Z
- Updated: 2026-09-14T17:23:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150633

The Government Accountability Office (GAO) says that since FDA established the limited population pathway for antibacterial and antifungal drugs (LPAD) in 2016, drug developers have formally requested approval under it for four drugs, two of which were approved. In a [report](ttps://www.gao.gov/products/gao-22-105042), GAO says FDA and stakeholders agreed that LPAD’s effect on the drug pipeline could be limited because the pathway does not address the economic challenges facing the development of these products.

As required by the 21st Century Cures Act, GAO produced the report describing **(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.