National Institute of Allergy and Infectious Diseases - Monday, April 19, 2004
Contact: Sarah Danberg, (703) 299-0878, sdanberg@idsociety.org

Under a recent proposal, the United States would require low-cost, generic AIDS drugs already being used in developing countries with great success to undergo a rigorous approval process before being eligible for purchase with funds from the President's Emergency Plan for AIDS Relief (PEPFAR). Currently, PEPFAR grantees are prohibited from using their federal funds to purchase any generic combination antiretrovirals. HIVMA and IDSA point out that these generic drugs have already been certified by WHO as part of the WHO Prequalification Program for Certifying Drugs for Purchase by U.N. Agencies, which is administered by an international panel of experts and includes inspections at manufacturing sites.

"Ensuring access to low-cost, high-quality generic antiretrovirals in the 14 developing countries in Africa and the Caribbean targeted by the PEPFAR initiative is essential to expand and sustain access to lifesaving medications to persons with HIV infection," said Paul Volberding, MD, chairman of HIVMA's Board of Directors. "The drug approval requirements being proposed will unnecessarily slow the process of getting antiretroviral drugs to people dying of AIDS, and will likely limit the numbers of people who can be treated because of the higher cost of brand name drugs."

In letters to Ambassador Randall Tobias, the U.S. Global AIDS Coordinator, and Department of Health and Human Services Secretary Tommy Thompson, HIVMA and IDSA argue that U.S. efforts to create a parallel system for regulating drugs in developing countries will limit the effectiveness of PEPFAR resources; unnecessarily delay the expansion of treatment; isolate the United States in its efforts to combat the AIDS pandemic; and impose a U.S.-based system on developing countries that will be unsustainable when PEPFAR resources are withdrawn.

"IDSA and HIVMA support the WHO Prequalification Program because it offers a credible and stringent set of standards and oversight processes," said Joseph Dalovisio, MD, IDSA's president. "These standards have long been used by the United States in the context of medications and vaccines for other infectious diseases."

HIVMA and IDSA applaud the president's ambitious plan to respond to the pandemic of HIV/AIDS and encourage the United States to adopt the WHO standards and move forward. "Funds from the president's plan should be used to quickly expand access to treatment," said Dr. Volberding, "not to create additional barriers where there are already so many to overcome."

The letters that were sent to Ambassador Randall Tobias, the U.S. Global AIDS Coordinator, and Department of Health and Human Services Secretary Tommy Thompson can be found on HIVMA's homepage at http://www.hivma.org.

HIVMA is the professional home for more than 2,600 physicians, scientists and other health care professionals dedicated to the field of HIV/AIDS. Nested within IDSA, HIVMA promotes quality in HIV care and advocates policies that ensure a comprehensive and humane response to the AIDS pandemic informed by science and social justice. The IDSA is a professional society representing more than 7,500 physicians and scientists who specialize in infectious diseases.
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