U.S. Expected to Increase Purchase of Generic Antiretrovirals Under PEPFAR

The U.S. government this year has "dramatically increased" the amount of generic antiretroviral drugs distributed under the President's Emergency Plan for AIDS Relief, and some data suggests that generic drugs soon will comprise 70% of antiretrovirals distributed in three PEPFAR countries, the Boston Globe reports. According to data from the first three months of this fiscal year, generics will account for more than 70% of antiretrovirals distributed in Nigeria, Haiti and Zambia -- a sevenfold increase in one year that is a "direct result" of FDA in the last year finding 29 generic drugs safe, according to the Globe. Last year, 11% of antiretrovirals in PEPFAR's 15 focus countries were generic. Although figures for this fiscal year will not be available until January 2007, some U.S. officials have said that they predict significant increases in the number of generic drugs distributed in every PEPFAR country, the Globe reports. According to Paul Davis, director of U.S. government relations at Health GAP, it is a "good thing" that PEPFAR is providing increased access to generic antiretrovirals, but it "was still a waste of time" to wait for FDA approval. Mark Dybul, who serves as the U.S. global AIDS coordinator and administers PEPFAR, last week said that the FDA process is vital for PEPFAR's long-term sustainability and safety. He added that the U.S. government "always has wanted the lowest-cost product as long as it was safe and effective." According to Dybul, 14 of the 15 PEPFAR focus countries are buying generic drugs (Donnelly, Boston Globe, 11/12).

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