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UN Health Bodies Welcome Revised US Guidelines on AIDS Treatments
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Associated Press
May 18, 2004
Sam Cage
On Tuesday, the UN-administered Global Fund to Fight AIDS, TB and malaria welcomed the news that the US Food and Drug Administration will fast-track its review process for generic combination drugs for AIDS patients in developing nations.
US Health and Human Services Secretary Tammy Thompson said Sunday that FDA will propose new guidelines aimed at cutting the time needed for the approval process - potentially to as little as a few weeks.
"I welcome the announcement," said Lee Jong-wook, director-general of the World Health Organization. "It is essential that medicines used in treatment programs financed by international donors be affordable and meet international quality, safety and efficacy requirements," he said.
"Clearly FDA approval of these drugs would lead many more countries to choose them," said Global Fund Executive Director Richard Feachem. The fund is financing a new effort to increase AIDS treatment access in more than 100developing nations. The fund welcomed the announcement from Bush administration global AIDS coordinator Randall Tibias that patent issues should not impede medication purchases under the president's $15 billion AIDS emergency plan. This will make it "much easier to harmonize drug protocols in countries where both the Global Fund and the... emergency plan finance drug purchase," Feachem said.
"For every additional person we are able to reach, this could literally mean the difference between life and death," said Mark Isaac, vice president of the Elizabeth Glaser Pediatric AIDS Foundation. "Now there must be a sense of urgency about implementing this new system as quickly as possible,both on the part of the administration and the pharmaceutical companies...so that we can be certain of the safety and efficacy of the drugs provided."
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