2004-5-23
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.