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FDA approves AIDS drugs for poor countries

Wed., Jan. 26, 2005

WASHINGTON – The $15 billion U.S. program to combat AIDS in poor countries won approval Tuesday to buy inexpensive combination drugs made by foreign companies, rather than more expensive brand-name products, opening the way to treat many more patients.

The Food and Drug Administration decision to approve a package of generic drugs by Aspen Pharmacare of South Africa effectively ends a bitter fight over whether President Bush’s ambitious AIDS initiative would be limited to buying patented drugs from drug makers in wealthy countries.

“It’s hard to exaggerate the importance of this announcement,” said Mark Isaac, vice president at the Elizabeth Glaser Pediatric AIDS Foundation, which uses money from the President’s AIDS initiative to treat patients in Zambia, South Africa, Tanzania and the Ivory Coast.

“For large number of people in Africa and beyond, this could be a true turning point,” he said. “This offers low-cost drugs for people who would otherwise face certain death. … We estimate we could serve two to three times as many people taking the same regimen.”

Other generics, especially from manufacturers in India, are in the same pipeline, and fixed-dose combination drugs are expected to become the mainstay of AIDS treatment in poor countries. By combining drugs made by different manufacturers into single pills, the generic companies offer easy-to-use formulations that are unavailable even to patients in wealthy countries, and at a fraction of the cost.

Tuesday’s approval brings the U.S. AIDS treatment initiative more into line with international treatment programs that have long advocated the use of cheaper generics. The drugs will not be sold in the United States because the combination pills violate U.S. patents.

“It’s wonderful news,” said Richard Feachem, executive director of the Global Fund to fight AIDS, Tuberculosis and Malaria, an independent foundation that is, along with the United States, among the largest funders of AIDS treatment programs in poor countries.

“This is an extremely significant step and very good news for the international effort to fight the global HIV-AIDS pandemic,” he said. “If one stream of money has one set of rules and another stream of money has another set of rules, it puts people on the front lines in an impossible position.”

The pharmaceutical industry has long raised concerns about the safety of such medications, but Tuesday’s announcement set concerns about Aspen Pharmacare’s package to rest, said Mark Grayson, a spokesman at the Pharmaceutical Research & Manufacturers Association of America.

Grayson rejected the notion that the industry had voiced safety concerns as a way to keep less expensive drugs from being purchased with U.S. funds: “It wasn’t a way to keep the drugs off the market. It was a way to make sure people got the appropriate medicines. … People in Africa deserve safe and effective medicines.”


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