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

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2005-2-20

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.