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President's Emergency Plan for AIDS Relief (PEPFAR)

Explore the PEPFAR Interactive Database

Search for information about tentatively approved and approved antiretroviral drugs that are eligible for procurement under the President’s Emergency Plan for AIDS Relief (PEPFAR) Program.

PEPFAR Database

The United States President's Emergency Plan for AIDS Relief (PEPFAR) is the U.S. Government’s initiative led by the Department of State’s Office of the U.S. Global AIDS Coordinator and Global Health Diplomacy (S/GAC) to address the HIV/AIDS epidemic around the world and help save the lives of those suffering from the disease. Since 2004, FDA’s support has been vital for PEPFAR’s success by ensuring that safe, effective, quality-assured antiretrovirals (ARVs), the medicine used to treat and prevent HIV, are available for distribution within the program. The contributions of the FDA have had a tremendous positive impact on the quality of life and life expectancy of people living with HIV/AIDS in the developing world.

The FDA’s Office of Global Policy and Strategy (OGPS) serves as the agency lead for PEPFAR issues. The FDA’s PEPFAR Coordinator, who resides in OGPS, is the primary point of contact internal to FDA and with other U.S. Government agencies including S/GAC, the Department of Health and Human Service’s Office of Global Affairs, the Centers for Disease Control and Prevention, and the U.S. Agency for International Development. The PEPFAR Coordinator serves as the point of contact for external organizations working on HIV/AIDS and related programs. In addition, the PEPFAR Coordinator works with drug firms seeking to participate in the FDA’s review process for antiretroviral (ARV) therapies for use in the PEPFAR focus countries.  For more information on FDA’s PEPFAR program please email fdapepfar@fda.hhs.gov. 

The FDA’s Center for Drug Evaluation and Research (CDER) reviews marketing applications for ARVs for the PEPFAR program through a Tentative Approval/Approval Program. PEPFAR only procures ARVs that have been granted tentative approval or approval by CDER to be distributed outside the United States.  CDER also maintains a PEPFAR database on the FDA’s website, with information about each approved or tentatively approved ARV drug eligible for procurement under PEPFAR. The database provides information on a mobile-friendly platform through interactive dashboards and in downloadable and searchable formats. CDER’s International Program works closely with the PEPFAR Coordinator and is the point of contact for CDER’s work under the FDA PEPFAR.


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