Access to High-Quality, Low-Cost Antiretrovirals in Developing Countries Major Challenge in Fight Against HIV/AIDS, Opinion Piece Says

A "little-noticed milestone was reached in the fight to save lives from AIDS 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 opinion piece. "One of the many needs that had to be met" in the fight against HIV/AIDS when President Bush announced PEPFAR was for a "supply of inexpensive, high-quality" antiretrovirals, Dybul and von Eschenbach write, adding that in 2004, FDA and HHS "adapted and expedited its review process for generic antiretroviral drugs products" to meet this need. Under the process, "products undergo the same rigorous scientific quality review that would make them eligible for use in the U.S. once patents expire," according to the authors.

The "benefits" of the expedited review process are not "limited to programs supported by PEPFAR," Dybul and von Eschenbach write, adding that through PEPFAR's Supply Chain Management System, the "lowest-priced products are now available for other programs serving the developing world as well." The expedited review process also has "made three generic drugs originally approved under PEPFAR now available" in the U.S. "because their patents expired," according to the authors. They add that in "short, the process has benefited both Africans and Americans."

Although "much progress has been made" in the fight against HIV/AIDS, "many challenges remain," Dybul and von Eschenbach write. "Because there is no cure or highly effective vaccine in sight, the need for HIV/AIDS treatment likely will be with us for generations," the authors write, adding that a "continuous stream of new, high-quality products to overcome the inevitable development of drug resistance" also will be needed. The U.S. approach "balances current and future needs for high-quality drugs that are affordable in resource-poor settings," according to Dybul and von Eschenbach. They conclude that this "effort plays a vital part in the American people's long-term commitment and leadership in the global fight against HIV/AIDS -- and it is something to celebrate" (Dybul/von Eschenbach, Washington Times, 8/31).

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