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FDA to Vow Fast Approval of AIDS Drugs
.c The Associated Press
WASHINGTON (AP) - The Bush administration on Sunday will promise rapid approval of AIDS drug combinations that could be used for lower-cost treatment in Africa, despite criticism that requiring stricter 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 Dr. 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 them,'' he said of foreign generic makers. Thus, ``I see an incentive for brand-name companies to get their act together to pursue fixed-dose combinations, too.''
Stephen Lewis, the U.N. special envoy on AIDS in Africa, also praised the decision.
``This is an unexpected and excellent move,'' he said before flying to Geneva. ``The United States has been raising unacceptable questions about the legitimacy of generic drugs for treatment of AIDS and now they seem to have reversed their position and accommodated the force of world opinion.''
``Fixed-dose combinations'' put into one pill several expensive treatments already sold in the United States 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 international 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,'' where one-time doses of different medicines are put together in blister packs for easier distribution and use abroad.
AIDS advocacy groups and members of Congress have blasted that position as a front to ensure sale of more expensive patented medicines that will delay if not block lifesaving treatment in regions hit hardest by the epidemic. Since patients already swallow multiple pills in treatment cocktails, WHO's assessment of which can be combined is plenty of evidence, the critics say.
``Anything that will help get affordable, easy-to-use medicine to people with HIV in developing countries is positive, but the danger here is that the United States is using quite a unilateral approach, which could lead to undermining the role of the World Health Organization in standard setting,'' said Rachel Cohen, a spokeswoman for the humanitarian group Doctors Without Borders.
But Cohen said she the U.S. approach could still lead to further delays in the availability of medicines that are already saving lives in Africa and elsewhere in the developing world.
Under the new plan, the FDA promises special fast reviews that could permit approval of combination or co-packaged products within two to six weeks after receiving applications, significantly faster than the usual six-months or longer review.
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.''
``This opens the marketplace,'' Health and Human Services Secretary Tommy Thompson said.
Both brand-name manufacturers and foreign generic makers can apply. FDA approval for the foreign generics would not allow their sale in the United States because of patent laws but would allow purchase for distribution in developing countries.
``Will it be this fast? I hope so,'' said the U.N.'s Piot. ``There is also a question of willingness of generic producers to apply.''
On the Net:
FDA AIDS site: http://www.fda.gov/oashi/aids/hiv.html
U.N. AIDS outlook: http://www.who.int/mediacentre/releases/2004/pr33/en/
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