with WHO to expedite the drugs’ addition to WHO’s list of prequalified medicines. Nonetheless, PEPFAR’s requirement for FDA approval rather than the globally accepted WHO prequalification was the most often-cited impediment to coordination and harmonization during the Committee’s visits to the focus countries, and continues to limit harmonization and rapid availability of PEPFAR-supported first-line ARVs. OGAC reported that only 10 percent of all PEPFAR-supported ARV purchases were for FDA-approved generics in fiscal year 2005, increasing to 27 percent in 2006 (OGAC, 2006f, 2007). Across the focus countries in 2006, the proportion of PEPFAR-supported ARV purchases for FDA-approved generics ranged from 0 to 87 percent (OGAC, 2007).

A previous IOM Committee strongly endorsed “a rigorous, standardized international mechanism to support national quality assurance programs for antiretroviral drugs” (IOM, 2005, p. 8). The Coordinator has not yet determined whether WHO prequalification provides such a mechanism and can adequately assure the quality of generic ARVs for purchase under PEPFAR. U.S. participation in such a mechanism would improve both coordination at the global level and harmonization at the country level, and facilitate more rapid availability of ARVs.

Recommendation 5-2: To support countries’ ownership of their responses to their HIV/AIDS epidemics, the U.S. Global AIDS Initiative should maintain its commitment to harmonization and participate fully in the development of harmonized procedures. To this end, the U.S. Global AIDS Coordinator should work to support World Health Organization (WHO) prequalification as the accepted global standard for assuring the quality of generic medications. Specifically, the Coordinator should provide an analysis of WHO prequalification that determines whether it can adequately assure the quality of generic antiretroviral medications for purchase under PEPFAR. If the analysis shows that WHO prequalification needs strengthening to provide a sufficient guarantee of quality for PEPFAR, the U.S. Global AIDS Initiative should work with other donors to support strengthening of the process, and work to transition from U.S. Food and Drug Administration approval to WHO prequalification as rapidly as feasible.

Human Resource Limitations

Although PEPFAR has supported the training of large numbers of health and laboratory workers, the human resource limitations facing treatment facilities are increasingly felt as treatment expands. A full discussion of human resource issues and the Committee’s related recommendation can be found in Chapter 8.



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