U.S. Says Expects to Approve More Generic AIDS Drugs

The United States expects to approve more generic AIDS drugs in coming months, the head of U.S. AIDS policy said on Wednesday, a move which would allow them to be included in a $15 billion U.S. anti-HIV program.

South Africa’s Aspen Pharmacare, Africa’s biggest generic drugs maker, in January became the first company to win regulatory approval from the U.S. Food and Drug Administration for its life-prolonging AIDS drugs. Activists have urged the FDA to speed up the process so that millions of people in poor countries living with the disease can have access to the drugs, less expensive copies of branded drugs developed in the United States and elsewhere. U.S. Global AIDS Coordinator Randall Tobias told the House of Representatives Appropriations subcommittee on foreign aid he expected more approvals to follow the Aspen Pharmacare decision. “We have put a lot of effort into hand-holding with generic companies around the world to encourage them so my guess is in the next few months we will see more generics approved,” he said. “The first company to apply was approved … and we expect more.” Last year, the United States announced a fast-track scheme for copycat drugs to get the FDA seal of approval for safety and quality, a move that allows recipients of U.S. grants to use the cheaper medicines rather than brands in developing countries. Activists are skeptical about the agency’s role since the World Health Organization already has its own “pre-qualification” scheme for AIDS drugs and they say the FDA is moving too slowly. “Cost effectiveness is very important but the Bush Administration’s process has turned out to be anything but fast track,” said David Bryden, director for the Global AIDS Alliance. “It has yet to provide any meaningful results and the (Aspen Pharmacare) drug in question is still not in use in any of the affected countries.” Generic antiretroviral drugs can costs as little as $140 per patient a year in poor nations compared to $470 for branded products, according to ActionAid. About 38 million people worldwide, including 25 million in sub-Saharan Africa, are living with HIV/AIDS. The number of people receiving the drugs in poor countries has jumped 75 percent in the past year, according to the United Nations. OTHER COUNTRIES MUST PAYThe Bush Administration’s $15 billion five-year AIDS initiative targets select countries in Africa and the Caribbean and Vietnam. The United States also contributes to a separate Global Fund to fight AIDS, Tuberculosis and Malaria. The size of the U.S. contribution depends on the contributions made by other countries, with Washington funding up to a maximum of one third of the fund’s overall operating budget. Tobias said it was not clear whether donations from other countries would allow the United States to use all of the $435 million Congress has set aside for the fund in the budget for the 2005 fiscal year. “We really need to encourage the rest of the world to step up,” he said. The Bush Administration has until July 31 to decide how much of the money it will use. Bush asked for $300 million in its budget for the 2006 fiscal year which starts on Oct.1, far less than the $1.5 billion the fund was hoping for. (Source: Reuters Health, March 2005)