PRNewswire (May 18, 10:17 AM) 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%.
Global AIDS Alliance
CONTACT: David Bryden of Global AIDS Alliance, +1-202-549-3664
Web site: http://www.globalaidsalliance.org/
