New American Policy on AIDS Drugs
By Jill Moss

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.

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