An Evaluation of US Food and Drug Administration’s Program to Register HIV Drugs for Use in Resource-Constrained Settings

Key Points Question What has the US Food and Drug Administration (FDA) program to review antiretroviral drugs for use in low-resource settings via the US President’s Emergency Plan for AIDS Relief (PEPFAR) achieved since its inception in 2004, and how could the program be more effective? Findings This cross-sectional study found that under PEPFAR, the FDA has authorized 216 applications for 272 antiretroviral drugs, including 26% for pediatric use. Ninety-five of 260 applications (37%) received 172 rejection letters, primarily for deficiencies in manufacturing processes (44%). Meaning The FDA’s efforts have made many HIV drugs available for use globally; however, more pediatric-specific therapies are needed, and the quality of applications needs to improve.