PEPFAR: The President’s Initiative for Combating AIDS Globally
Discover the PEPFAR Interactive Database
Find details about tentatively approved and approved antiretroviral medications available for procurement under the President’s Emergency Plan for AIDS Relief (PEPFAR) Program.
Industry Insights
Gain insights into the FDA’s tentative approval process for the President’s Emergency Plan for AIDS Relief (PEPFAR) Program here.
The President’s Emergency Plan for AIDS Relief (PEPFAR) is a significant initiative by the U.S. Government, directed by the Department of State’s Bureau of Global Health Security and Diplomacy (GHSD), aimed at tackling the global HIV/AIDS crisis and providing assistance to individuals affected by the illness. Since its inception in 2004, the FDA’s involvement has played an essential role in PEPFAR’s efficacy by ensuring that reliable, high-quality antiretrovirals (ARVs), the drugs used to treat and prevent HIV, are accessible for distribution through this program. The efforts of the FDA have significantly improved the quality of life and longevity for individuals living with HIV/AIDS in developing nations.
The FDA’s Office of Global Policy and Strategy (OGPS) is the designated leader for PEPFAR-related matters. The PEPFAR Coordinator within OGPS acts as the primary liaison within the FDA and collaborates with other U.S. Government sectors, including the GHSD, the Department of Health and Human Services’ Office of Global Affairs, the CDC, and the USAID. This Coordinator also engages with external entities involved in HIV/AIDS initiatives. Furthermore, the PEPFAR Coordinator assists pharmaceutical companies aiming to navigate the FDA’s review process for ARVs intended for the PEPFAR focus countries. For further assistance regarding the FDA’s PEPFAR operations, please reach out via email at fdapepfar@fda.hhs.gov.
The FDA’s Center for Drug Evaluation and Research (CDER) evaluates marketing applications for ARVs associated with the PEPFAR program through a Tentative Approval/Approval framework. Only ARVs that receive tentative approval or final approval from CDER are eligible for procurement under PEPFAR for distribution beyond U.S. borders. Additionally, CDER offers a PEPFAR database hosted on its website, which contains comprehensive details about each approved or tentatively approved ARV available through PEPFAR. This database features a user-friendly mobile platform along with interactive dashboards, downloadable, and searchable formats. The International Program at CDER collaborates closely with the PEPFAR Coordinator and serves as the primary contact for CDER’s engagement in the FDA PEPFAR efforts.
Guidance Documents
Publications
- FDA launches mobile-friendly database with information on life-saving HIV drugs as part of ongoing mission to empower the public through increased access to information and data, FDA Press Announcement, January 2022
- Bookmark this Site! FDA’s Comprehensive Database on Antiretroviral Drugs for HIV under PEPFAR, From a Global Perspective, December 2020
- PEPFAR: FDA Approves 200th HIV/AIDS Therapy, FDA Voices, December 2018
- An Evaluation of US Food and Drug Administration’s Program to Register HIV Drugs for Use in Resource-Constrained Settings, JAMA Network Open, November 2019
- FDA’s Comprehensive Response to HIV — Part I, FDA Voices, September 2019
- FDA’s Comprehensive Response to HIV — Part II, FDA Voices, September 2019
- Impact of the US Food and Drug Administration registration of antiretroviral drugs on global access to HIV treatment, BMJ Global Health, 2018
- The US Food and Drug Administration’s tentative approval process and the global fight against HIV, JIAS, December 2017