The U.S. President's Emergency Plan for AIDS Relief (PEPFAR) is the U.S. Government’s response to save the lives of those suffering from HIV/AIDS around the world. This public health commitment is the largest by any nation to combat a single disease internationally. PEPFAR partially reimburses FDA’s Center for Drug Evaluation and Research (CDER) to review marketing applications for antiretrovirals (ARVs) to treat HIV/AIDS that are intended to be marketed outside of the United States. The Program has had a tremendous positive impact on the quality of life and life expectancy of people living with HIV/AIDS in the developing world by increasing the availability of quality-assured ARVs to combat HIV/AIDS globally. PEPFAR supports more than 14 million people with life-saving ARV treatment. FDA’s Tentative Approval/Approval Program along with the expedited review process has either tentatively approved or approved over 200 new and abbreviated drug applications (containing 256 ARV products) for procurement by PEPFAR and the Global Fund to Fight AIDS, Tuberculosis, and Malaria (the Global Fund).
PEPFAR only procures ARVs that have been granted tentative approval or approval by FDA/CDER to be distributed outside the United States.
The CDER International Program is the point of contact for CDER and coordinates with FDA’s Office of Global Policy and Strategy (OGPS), HHS, and USAID on PEPFAR efforts and outreach activities.