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 anti-HIV drugs, 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. antiretroviral drug manufacturers at the expense of AIDS patients in the developing world.
The FDA backing means the product made by Aspen Pharmacare, South Africa's largest drugmaker, which combines two pills in a package, can now be purchased by relief organizations funded by President Bush's $15 billion President's Emergency Plan for AIDS relief. The five-year relief program was approved by Congress in 2003, but a policy decision was made to not pay for drugs unless they had been approved by the FDA. The generic combination therapy will not be available in the United States or other Western nations because of patent protections on the brand-name versions of the medications.
Tuesday's approval 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 and a second pill that is a generic version of Viramune, made by Boehringer Ingelheim. Aspen officials could not be reached for comment, but AIDS experts estimate that the cost of the combination treatment will be about $20 to $30 per person per month. (AP)