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US: $15 Billion AIDS Initiative to Purchase Only Drugs Whose Safety Has Been Proved - 2004-04-28

In a visit to South Africa, the coordinator of President Bush's $15 billion AIDS initiative said that the new money would be used only to purchase anti-retroviral drugs whose safety had been proved. Randall Tobias called for makers of generic drugs to submit their products for approval by the Food and Drug Administration.

There were applause and cheers when U.S. Global AIDS Coordinator Randall Tobias signed an agreement giving $10 million from President Bush's emergency AIDS fund to a South African non-governmental organization called Right to Care.

The organization is one of the first to receive money from the five-year, $15 billion AIDS initiative. Much of the fund's money is to go to groups like Right to Care which are providing anti-retroviral treatment to HIV-positive victims.

With the new money from the fund, the organization hopes to begin treating at least 4,000 people with the life-extending drugs by next March. In all, the goal of the president's program is to provide treatment for two million people in 14 of the world's hardest hit countries, as well as to prevent seven million new cases of infection and care for 10 million orphans and victims of AIDS.

While most AIDS activists laud President Bush's decision to devote new money to the AIDS fight, his administration has come under attack for its decision to use only AIDS drugs approved by the FDA or the corresponding regulatory agencies of countries that have equally strict standards.

This would exclude drugs produced by companies such as Cipla and Ranbaxy of India, which have struck deals with the World Health Organization and the World Bank to provide generic versions of anti-retroviral drugs at record-low prices.

AIDS groups argue that twice as many people could be treated with the same amount of money if generic anti-retrovirals were used.

The World Health Organization believes the anti-retroviral drugs produced by generic manufacturers are safe, but Mr. Tobias said the WHO's regulations were not stringent enough.

"The fundamental issue is that maybe these drugs are safe and effective, maybe these drugs are exactly duplicates of the research-based drugs," he said. "Maybe they are not. Nobody really knows."

The AIDS coordinator called on manufacturers of generic drugs to submit their products for approval and said the U.S. government would try to expedite their approval.

Until then, he emphasized, the United States would buy drugs for the president's AIDS program from companies that had received such approval, even if they were more expensive.