Access To Antiretrovirals In Developing Countries Challenge In Fight Against HIV/AIDS

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A "little-noticed milestone was reached in the fight to save lives fromAIDS with high-quality antiretroviral treatment" last week when FDA "granted its 50th and 51st priority approvals for HIV/AIDS medications, making them eligible for purchase" by the President's Emergency Plan for AIDS Relief, Ambassador Mark Dybul, who serves as the U.S. global AIDS coordinator and administers PEPFAR, and FDA Commissioner Andrew von Eschenbach write in a Washington Times opinionpiece. "One of the many needs that had to be met" in the fight againstHIV/AIDS when President Bush announced PEPFAR was for a "supply ofinexpensive, high-quality" antiretrovirals, Dybul and von Eschenbachwrite, adding that in 2004, FDA and HHS "adaptedand expedited its review process for generic antiretroviral drugsproducts" to meet this need. Under the process, "products undergo thesame rigorous scientific quality review that would make them eligiblefor use in the U.S. once patents expire," according to the authors.

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The"benefits" of the expedited review process are not "limited to programssupported by PEPFAR," Dybul and von Eschenbach write, adding thatthrough PEPFAR's Supply Chain Management System, the "lowest-pricedproducts are now available for other programs serving the developingworld as well." The expedited review process also has "made threegeneric drugs originally approved under PEPFAR now available" in theU.S. "because their patents expired," according to the authors. Theyadd that in "short, the process has benefited both Africans andAmericans."

Although "much progress has been made" in thefight against HIV/AIDS, "many challenges remain," Dybul and vonEschenbach write. "Because there is no cure or highly effective vaccinein sight, the need for HIV/AIDS treatment likely will be with us forgenerations," the authors write, adding that a "continuous stream ofnew, high-quality products to overcome the inevitable development ofdrug resistance" also will be needed. The U.S. approach "balancescurrent and future needs for high-quality drugs that are affordable inresource-poor settings," according to Dybul and von Eschenbach. Theyconclude that this "effort plays a vital part in the American people'slong-term commitment and leadership in the global fight againstHIV/AIDS -- and it is something to celebrate" (Dybul/von Eschenbach, Washington Times, 8/31).
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