in the focus countries, all of which rely on the WHO Prequalification of Medicines Project to assure the quality of ARVs for purchase under their programs (see Box 5-4).

The majority of the focus countries have chosen to use generic versions of ARVs in their national programs, and a number of generic ARVs have been prequalified by WHO. When PEPFAR started, however, no generic ARVs had FDA approval, and thus the focus countries were unable to use PEPFAR funds to support their purchase—particularly first-line ARVs and medications that combine two or three ARVs into one pill, known as fixed-dose combinations. Consequently, focus countries whose plans called for generic ARVs made arrangements, whenever possible, to use other sources of funding to purchase the desired generics, and used PEPFAR funds for the purchase of ARVs for which no generic version was available—primarily second-line and pediatric formulations.

Subsequently, the Coordinator supported an expedited FDA review process for generic ARVs (DHHS, 2004; DHHS et al., 2006), and since December 2004 when the first such drug was approved, more than 30 generic versions of first-line ARVs have been FDA-approved for purchase by PEPFAR, including several of the two- and three-drug fixed-dosed combinations suitable for adults as well as several pediatric formulations (FDA, 2006; OGAC, 2007). However, some of the fixed-dose combination ARVs most desired by the focus countries were approved by the FDA only within the past year (FDA, 2006). Moreover, because some focus countries rely on WHO prequalification, they require it in addition to FDA approval. To partly address this problem, the FDA has agreed to share its drug files

BOX 5-4

The WHO Prequalification of Medicines Project

The WHO Prequalification of Medicines Project started in 2001 with the mission of facilitating access to medicines that meet unified standards of quality, safety, and efficacy for HIV/AIDS, malaria, and tuberculosis. The United Nations and the World Bank support WHO prequalification as a key contribution to the United Nations’ priority goal of addressing widespread diseases in countries with limited access to quality medicines. Prequalification evaluates products submitted by companies around the world according to WHO standards of quality, safety, and efficacy. When products are found to meet those standards, they are added to a list accessible to United Nations organizations, countries, and procurement agencies.

SOURCE: WHO, 2006b.

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