The Bush administration today will promise rapid approval of AIDS drug combinations that could be used for lower-cost treatment in Africa, which could allay criticism that U.S. standards could delay care to the world's poor.
The new system, being disclosed at a World Health Organization meeting in Geneva, is open to foreign makers of generic drugs, which makes those approved eligible for purchase under the $15 billion U.S. global AIDS program.
That is "a real change in policy," said Peter Piot, executive director of the U.N. AIDS organization, who has been closely watching the U.S. debate. "This is a big market" for foreign generic makers, he said, adding, "I see an incentive for brand-name companies to get their act together to pursue fixed-dose combinations, too."
Fixed-dose combinations put into one pill several treatments sold separately by brand-name companies. Foreign companies have begun manufacturing low-cost generic versions of anti-HIV drugs and combining them into single pills.
The World Health Organization has signaled which combinations are appropriate for use in its push to get lower-cost HIV treatment to developing countries.
U.S. officials have argued for more stringent standards: formal Food and Drug Administration approval of the one-pill combinations and of "co-packaged drugs" that combine doses of different medicines in blister packs for easier distribution and use abroad.
AIDS advocacy groups and members of Congress have criticized that position as a front to ensure the sale of more expensive patented medicines that will delay if not block lifesaving treatment in regions hit hardest by the epidemic.
Under the new plan, the FDA promises fast reviews that could permit approval of combination or co-packaged products within two to six weeks.
No scientific studies of the drugs in patients will be needed, only data showing that putting three medicines into the same pill does not affect their chemical makeup or how they are absorbed by the body, administration officials said.
"We must apply real discipline to ensure that the products we provide in poor nations are safe and effective," White House global AIDS coordinator Randall Tobias said. "The new expedited process provides us with a solid foundation for purchasing drugs that work."