On October 6, the U.S. Food and Drug Administration (FDA), within the U.S. Department of Health and Human Services (HHS), announced the approval of the 100th antiretroviral drug (ARV) in association with the U.S. President's Emergency Plan for AIDS Relief (PEPFAR).

"This milestone exemplifies the dedication, caring, and hard work of all who strive to better the lives of those infected with or affected by HIV/AIDS," said HHS Secretary Kathleen Sebelius.

In fiscal year 2008 alone, PEPFAR provided nearly $1.6 billion in support of treatment programs, including antiretroviral drugs and services.

Since the program's inception, the U.S. Government, through PEPFAR, has worked to increase the availability of safe, effective, low-cost, and generic ARVs in the developing world through an expedited "tentative approval" process conducted by HHS/FDA. Through this process, ARVs from anywhere in the world, produced by any manufacturer, can be rapidly reviewed to assess quality standards and subsequently cleared for purchase under PEPFAR.

The expedited tentative approval process is employed for PEPFAR-procured drugs used abroad that cannot be approved for marketing in the United States due to existing patents and marketing exclusivity.

Through this approval process, PEPFAR can ensure that the drugs purchased for use abroad meet all of HHS/FDA's manufacturing quality, clinical safety, and efficacy requirements. Additionally, tentatively approved drugs are added to the World Health Organization's prequalification list of generic ARVs.

PEPFAR is proud of this milestone and looks forwards to continuing procurement of safe, effective drugs that are of high quality and consistent with international law.

"PEPFAR is committed to supporting partner countries to build and maintain sustainable procurement and supply chain systems," said Ambassador Eric Goosby, U.S. Global AIDS Coordinator.