[Ip-health] Global AIDS Alliance: New Policy on AIDS Drugs a Slap to WHO and European Allies

[Mike Palmedo]

http://biz.yahoo.com/prnews/040518/dctu034_1.html

Press Release    Source: Global AIDS Alliance

New Policy on AIDS Drugs a Slap to WHO and European Allies
Tuesday May 18, 10:15 am ET

WASHINGTON, May 18 /PRNewswire/ -- Sixteen months after proposing an
Emergency Plan to fight AIDS, the Bush Administration has finally
declared its willingness to allow grant recipients to purchase AIDS
drugs that combine various medications into one pill. Yet, the generic
companies that make the combination must submit to a new FDA review
process likely to be far from quick and easy.

A Senate hearing today at 10:30am will see tough questions about the
policy directed at the US Global AIDS Coordinator, Randall Tobias,
former CEO of Eli Lilly, and activists are planning a major protest for
Thursday.

"This is the US saying 'We Americans know best,'" said Dr. Paul Zeitz,
Executive Director of the Global AIDS Alliance. "The World Health
Organization has already declared these drugs safe on the basis of a
rigorous evaluation. This new policy is a slap in the face to our
European and other allies, whose regulatory agencies participate in
WHO's review process."

The US prohibition on purchase of generic AIDS medication has caused
anger and confusion in countries slated to benefit from the Bush plan.
The Global Fund, with US financial support, already finances the
purchase of the generic combination pills, even though they are not FDA
approved. And, a recent study published in the New England Journal of
Medicine found the generic combination was best for new patients.

It is unclear whether generic manufacturers can expect a fair review. In
a sign of favoritism, the Administration tipped off several brand-name
manufacturers prior to announcing the policy change. These companies
immediately announced their own combination AIDS drug, though their
proposed medication is not recommended as a first line drug by WHO.

"Promising that this new evaluation could take just two to six weeks is
unrealistic," stated Dr. Zeitz. "There are multiple hurdles the
manufacturers must jump through and so-called 'data exclusivity' could
lead to disqualification. Meanwhile, agencies already using US funds may
find themselves locked into continued use of brand-name medications. It
is far from clear this new process will lead to greater access to low
cost medication."

The US contribution to a major purchaser of generics, the Global Fund,
could be cut dramatically if President Bush prevails in spending
negotiations with Congress. The President has proposed cutting the US
contribution by 64%.