"Support for antiretroviral treatment is more than just drugs –
it is a sign of hope," said Ambassador Mark Dybul, the U.S. Global
AIDS Coordinator. "It reflects the idea that President Bush has
stated so well - that where you live should not determine if you
live or die from HIV/AIDS."
In 2004, FDA implemented an expedited PEPFAR application review
process for individual antiretroviral (ARV) drug formulations,
co-packaged versions of individual ARV drug formulations, and
fixed-dose ARV combinations. The process includes an FDA commitment
to work closely with manufacturers before they submit a marketing
application to the FDA, especially those who have never previously
submitted marketing applications, and to conduct a priority
assessment of those applications.
"The FDA has helped save lives by making these much-needed,
high-quality, generic drugs for AIDS available for patients in
countries served by PEPFAR," said Andrew C. von Eschenbach, M.D.,
Commissioner of Food and Drugs. "In addition, our goal is to assure
that drugs purchased by PEPFAR meet the same safety, efficacy, and
manufacturing standards as drugs used in the United States."
PEPFAR remains committed to funding the purchase of the
lowest-cost ARVs, whether they are innovator or generic drugs, as
long as the medications have been demonstrated to be safe,
effective, and of high quality. PEPFAR purchases also must be
consistent with international law.
As part of the PEPFAR initiative, FDA is collaborating with the
World Health Organization's Prequalification Program (WHO/PQ). As a
result of this collaboration, FDA approved or tentatively approved
antiretroviral drugs are placed on the WHO Prequalification Program.
This is a program many countries with developing economies use to
guide their purchasing of drug products from specific manufacturers
so that they can be assured they are purchasing quality medicinal
"The countries of the world that depend on the WHO
Prequalification Programme to help them purchase quality products
have benefited immensely by this cooperation between the FDA and the
WHO," said Dr. Howard Zucker, WHO Assistant Director General for
Health and Pharmaceuticals. "Assuring the quality of products like
this one made especially for children in developing economies is a
major cornerstone of our battle against the HIV epidemic and of our
effort to help assure children have access to quality medicines."
In addition, HHS and FDA continue to work to strengthen the
knowledge and training of in-country, national drug regulatory
authorities in the PEPFAR focus countries, alone and in
collaboration with each other, so that they can better ensure the
quality of the medical products available to their citizens.
For more information on PEPFAR, visit
To see a consumer article called Improving Access to HIV/AIDS
Drugs Abroad, visit