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U.N. welcomes new U.S. antiretroviral guidelines

U.N. welcomes new U.S. antiretroviral guidelines

United Nations health authorities on Tuesday welcomed new U.S. guidelines on drug approvals, which they say will make it easier for AIDS sufferers in developing countries to receive lower-cost treatment. The United Nations-administered Global Fund to Fight AIDS, Tuberculosis, and Malaria said the fast-track U.S. Food and Drug Administration review process could reduce approval time for generic combinations of drugs to as little as a few weeks. "Clearly, FDA approval of these drugs would lead many more countries to choose them," said Richard Feachem, executive director of the global fund, which is financing a major scaling up of AIDS treatment in more than 100 developing countries. U.S. Health and Human Services secretary Tommy Thompson said Sunday the FDA will propose new guidelines to ease the approval process for products that combine several expensive treatments already approved individually by the FDA. "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." Mark Isaac, vice president of the U.S.-based Elizabeth Glaser Pediatric AIDS Foundation, said faster approval for combination drugs would mean his organization would be able to help more people suffering from AIDS. "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," he said.

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