Broadcast: May 24, 2004
This is Robert Cohen with the VOA Special English Development Report.
The United States has announced a new drug approval process for AIDS medicines for developing countries. Health and Human Services Secretary Tommy Thompson announced it at a World Health Organization meeting in Geneva.
Mister Thompson said the program will speed up the release of low-cost AIDS drugs to nations in Africa and the Caribbean. The program is part of President Bush’s fifteen-thousand-million-dollar emergency AIDS plan. The Food and Drug Administration will supervise the program.
Several different drugs are generally used together to suppress H.I.V., the virus the causes AIDS. The new policy urges drug companies to produce treatments that would combine up to three anti-retroviral drugs in a single pill. These are called fixed-dose combinations. Drug companies are also being 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 develop combination products. Such efforts might require competing companies to work together.
The new policy involves AIDS drugs purchased by the United States for developing countries. American officials say the new policy will help them make sure of the quality of the drugs.
Under the plan, companies that make name-brand drugs or their generic copies can equally seek F.D.A. approval. They can offer existing research to show that the drugs are safe and effective. Companies must also show that a proposed combination product could be manufactured quickly. In some cases, the Food and Drug Administration could decide within two to six weeks if a request will be approved.
AIDS activists have long accused the United States of protecting drug makers from competition from lower-cost versions of their drugs. They point out that there is already a list of AIDS drugs approved by the World Health Organization. This list includes generic copies. But W.H.O. Director General Lee Jong-wook says he welcomes the new approval program. He says AIDS drugs paid for by international agencies and governments must meet quality and safety requirements.
This VOA Special English Development Report was written by Jill Moss. This is Robert Cohen.