White House Aims to Answer Critics of Its AIDS Fight

In an effort to quiet controversy over whether its global AIDS funds can be spent on cheaper, foreign-made combination treatments, the Bush administration is working to develop a quick approval process for the drugs, according to senior officials.

At present, those receiving the U.S. funds are told to buy only brand-name products. Under the new process, the manufacturers of the copy drugs and brand-name pharmaceutical companies ostensibly would be able to go through the Food and Drug Administration approval process, which would take one to two months. "The Indian companies can apply to the FDA for approval for their new HIV drugs, and if the data they submit shows that these drugs are safe and effective, FDA could approve them," said a senior FDA official, speaking on condition of anonymity. "As a practical matter, the Indian companies would probably be free to market these drugs in Africa, since the innovator companies have already said they would not enforce their patents in that continent."

While no brand-name companies currently make the combination drugs at issue, the FDA process could pave the way for that to happen quickly. Expediting the approval process is one option being considered as administration officials set up rules for which drugs recipients of the funds can buy to treat patients in Africa. They also said they are working with the World Health Organization, which has approved certain treatments for use in poor countries, to get the data that would allow U.S. approval of their use. AIDS activists contend the WHO review should be sufficient.

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