[Ip-health] AP on upcominig US announcement on FDC ARVs

[Mike Palmedo]

[snip]

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.

[snip]

http://www.ajc.com/health/content/shared/health/ap/ap_story.html/Health/AP.V6120.AP-Global-AIDS.html

FDA to Vow Fast Approval of AIDS Drugs

By LAURAN NEERGAARD
AP Medical Writer

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.''