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Since 2005, the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) has relied on the FDA's tentative approval process to expedite review of generic antiretroviral agents (ARVs) and increase their use. How has the use of generics changed over time, and how much money has been saved?
To find out, U.S. government employees and contractors analyzed data from PEPFAR-funded treatment programs in 16 countries, gathered through annual surveys in fiscal years 2005 to 2008. These surveys included questions about the volume and purchase prices of drugs procured (in “packs,” each representing a 1-month supply). The investigators obtained comparative prices for branded medicines from Médicins Sans Frontières reports and country-specific sources. To…