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US Says Expects to Approve More Generic AIDS Drugs
  Reuters (03.02.05)::Anna Willard
On Wednesday in Washington, US Global AIDS Coordinator Randall Tobias told the House of Representatives Appropriations subcommittee on foreign aid that more generic HIV drugs are expected to gain US approval soon - a move that would allow them to be distributed as part of the nation's $15 billion international AIDS program.
"We have put a lot of effort into hand-holding with generic companies around the world to encourage them so my guess is in the next few months we will see more generics approved," said Tobias. "The first company to apply was approved. and we expect more." In January, South Africa's Aspen Pharmacare became the first company to win US Food and Drug Administration approval for its generic AIDS drugs.
A fast-track plan announced last year aims to get FDA approval for the generics so that they, rather than more expensive name-brand drugs, can be purchased by US grant recipients in developing nations. Activists, however, are skeptical about FDA's role. They say the agency is moving too slowly, and they note that the World Health Organization already has its own pre-qualification system for AIDS drugs.
In addition to the Bush administration's five-year, $15 billion AIDS plan targeting Vietnam and selected nations in Africa and the Caribbean, the United States contributes separately to the Global Fund to Fight AIDS, TB and Malaria. However, its contribution cannot constitute more than one-third of the fund's budget. It is not clear whether the donations of other countries will be sufficient to allow the United States to use all the $435 million Congress allocated for the fund in fiscal 2005. The administration has until July 31 to decide how much of the money it will use. The president's $300 million Global Fund request for fiscal 2006 is far less than the $1.5 billion the fund was hoping for.

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