DEVELOPMENT
REPORT - New American Policy on AIDS Drugs
By Jill Moss
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.
| 
