The U.S. Food and Drug Administration tentatively approved on Tuesday a generic and less costly version of one of the most widely used combination of AIDS drugs (search), an action that is expected to expand AIDS treatment in the developing world.
The approval came as part of an expedited FDA review process program that was started last year after the Bush Administration was criticized for refusing to purchase drugs that hadn't been reviewed by the FDA. AIDS activists contended the administration was trying to bolster the sales of U.S. AIDS drugs manufacturers at the expense of AIDS patients in the developing world.
The FDA backing means the product made by Aspen Pharmacare (search), South Africa's largest drug maker, which combines two pills in a package, can now be purchased by relief organizations funded by President Bush's $15 billion Emergency Plan for AIDS relief (search). The five-year relief program were approved by Congress in 2003, but a policy decision was made to not pay for drugs unless they had been approved by the FDA.
It marks the first time the FDA has approved a generic AIDS product made by a foreign drug company. The FDA did approve a generic drug made by Barr Laboratories last December, but Tuesday's announcement is considered a major advancement because the Aspen drug combination is so widely used as a first-line therapy.
Aspen's product combines one pill that contains a generic equivalent of two drugs made by GlaxoSmithKline PLC of the United Kingdom, and a second pill that is a generic version of the Nevirapine drug made by Boehringer Ingelheim GmbH of Germany. The two drugmakers earlier licensed Aspen to produce the drugs.
"For people in Africa and beyond this can be a turning point in providing low cost, safe and effective drugs to people who otherwise would have died," said Mark Isaac, vice president of the Elizabeth Glaser Pediatric AIDS Foundation, which receives funding from the President's plan.
Aspen officials could not be reached for comment but Isaac estimates that the cost of the combination treatment will be about $20 to $30 per person per month. His foundation now pays $55 per person per month for the same drugs.
In the U.S., there are no AIDS pills that combine medicines from different manufacturers, although some companies are working on such an approach.
The approval is considered tentative because Aspen won't be able to sell its regimen in the United States where its components remain under patent protection, said Dr. Murray Lumpkin, the FDA's acting deputy commissioner for international and special projects.
Last year, the administration created an expedited review process for generic manufacturers wanting a single drug approved or any manufacturers looking to combine a mixture of drugs. Generic manufacturers that sell their products in the developing world routinely combine drugs made by different companies in one pill. Activists say combination pills help increase compliance.
The FDA said it reviewed Aspen's application in two weeks but had been working with the company for several months.
"I think this demonstrates that we are committed to providing low cost (AIDS) drugs as long as they are safe and effective," said Dr. Mark Dybul, assistant U.S. Global AIDS Coordinator.
Isaac said the Elizabeth Glaser Pediatric AIDS Foundation treats about 3,000 people with the product that Aspen has been cleared to sell. But that number could rise to as much as 9,000 depending on the price and availability, he said.