NEW YORK - 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, 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
The FDA backing means the product made by Aspen Pharmacare, 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. 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
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
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.