This is Robert Cohen with the VOA Special English DevelopmentReport.
The United States has announced a new drug approval process forAIDS medicines for developing countries. Health and Human ServicesSecretary Tommy Thompson announced it at a World Health Organizationmeeting in Geneva.
Mister Thompson said the program will speed up the release oflow-cost AIDS drugs to nations in Africa and the Caribbean. Theprogram is part of President Bush’s fifteen-thousand-million-dollaremergency AIDS plan. The Food and Drug Administration will supervisethe program.
Several different drugs aregenerally used together to suppress H.I.V., the virus the causesAIDS. The new policy urges drug companies to produce treatments thatwould combine up to three anti-retroviral drugs in a single pill.These are called fixed-dose combinations. Drug companies are alsobeing urged to put existing medicines together in the same package.This kind of combination is called co-packaging.
Several drug companies say they have already started to developcombination products. Such efforts might require competing companiesto work together.
The new policy involves AIDS drugs purchased by the United Statesfor developing countries. American officials say the new policy willhelp them make sure of the quality of the drugs.
Under the plan, companies that make name-brand drugs or theirgeneric copies can equally seek F.D.A. approval. They can offerexisting research to show that the drugs are safe and effective.Companies must also show that a proposed combination product couldbe manufactured quickly. In some cases, the Food and DrugAdministration could decide within two to six weeks if a requestwill be approved.
AIDS activists have long accused the United States of protectingdrug makers from competition from lower-cost versions of theirdrugs. They point out that there is already a list of AIDS drugsapproved by the World Health Organization. This list includesgeneric copies. But W.H.O. Director General Lee Jong-wook says hewelcomes the new approval program. He says AIDS drugs paid for byinternational agencies and governments must meet quality and safetyrequirements.
This VOA Special English Development Report was written by JillMoss. This is Robert Cohen.