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U.S. Approves Foreign-Made AIDS Treatment for Developing Nations

I'm Gwen Outen with the VOA Special English Development Report.

The United States Food and Drug Administration has given early approval to a lower-cost AIDS treatment for developing nations. The manufacturer is Aspen Pharmacare of South Africa. This is the first time the Food and Drug Administration has approved foreign-made copies of drugs to treat H.I.V. infections.

Different drugs are generally used together to suppress H.I.V., the virus the causes AIDS. The newly approved treatment involves two pills taken two times a day. It is a generic copy of one of the most widely used combinations of antiretroviral drugs. These drugs generally cost about six hundred dollars a year. But Aspen is expected to sell its copies for perhaps half the price.

Final approval by the F.D.A. is still needed. But the agency says its action means that the drugs meets the same quality and safety requirements as medicines for the United States. And that means President Bush’s emergency AIDS plan could pay for them.

Congress approved the five-year, fifteen thousand million dollar plan in two thousand three. But officials decided not to pay for drugs unless the F.D.A. had approved them. AIDS activists accused the United States of protecting drug makers from competition from lower-cost versions of their drugs.

Such criticism led the F.D.A. last year to establish a faster approval process. Agency officials say they completed their work within two weeks after Aspen requested approval.

The Bush administration says it hopes to provide AIDS treatment for two million people by two thousand eight. Most will be in Africa and the Caribbean.

The number of people receiving antiretroviral treatment in developing countries has increased sharply. The World Health Organization reports that seven hundred thousand people were receiving treatment by the end of last year. That was up about seventy-five percent from a year earlier. And it met a target for two thousand four.

W.H.O. Director General Lee Jong-wook praised the increase when he appeared last month at the World Economic Forum in Davos, Switzerland. However, he warned that governments and the international community need to do more.

The W.H.O. wants three million people living with AIDS to be receiving antiretroviral medicines by the end of two thousand five. This is known as the "three-by-five" campaign.

This VOA Special English Development Report was written by Jill Moss. I'm Gwen Outen.