particularly as the partner countries improve their national programs and become more directive with donors, there is room for the U.S. Global AIDS Initiative to improve on all three aspects of harmonization, and greater flexibility would facilitate this improvement.

Closer coordination and cooperation with other international donors at both the global and country levels is also necessary for harmonization to succeed in empowering countries. As the number of donors and the amount of available resources increase, so, too, will the need for coordination. As highlighted by the Leadership Act, a key feature of U.S. leadership is commitment to coordination at all levels. At the global level, it is essential for the United States to continue to work closely with other multilateral and bilateral donors to ensure that the comparative strengths of each are maximized and have a positive, synergistic impact on countries, rather than a duplicative, inefficient, and disempowering one (OECD, 2003; UNAIDS, 2005a; GIST, 2006).

To support country leadership, the U.S. Global AIDS Coordinator should seek to identify and remove barriers to coordination with partner governments and other donors, with a particular focus on promoting transparency and participation throughout the annual planning process. (3.1)

During the Committee’s visits to the focus countries, the most frequently cited example of an impediment to coordination and harmonization was PEPFAR’s requirement for U.S. Food and Drug Administration (FDA) approval of ARVs. A previous IOM Committee strongly endorsed “a rigorous, standardized international mechanism to support national quality assurance programs for antiretroviral drugs” (IOM, 2005a, p. 8). The international mechanism on which most other donors and the majority of the PEPFAR focus countries rely is the World Health Organization (WHO) Prequalification of Medications Project (WHO, 2006b). When PEPFAR was initiated, however, the Coordinator determined that FDA approval would be the standard for ensuring the quality of PEPFAR-provided ARVs (OGAC, 2004). This standard posed a major challenge to implementation because most of the focus countries had selected generic versions of ARVs for their formularies, and no generic ARVs had FDA approval (GAO, 2005). Subsequently, the Coordinator has fostered and supported an expedited FDA review process for generic ARVs, and since December 2004, more than 30 generic versions of the first-line ARVs have been FDA-approved for purchase by PEPFAR (DHHS, 2004; FDA, 2006; OGAC, 2006c). However, many of these medications, including some of the fixed-dose combination ARVs that are most desirable in the focus countries, were approved only within the past year (FDA, 2006). According to OGAC, only 10 percent of total PEPFAR-supported ARV purchases were for FDA-approved generics



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