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Date: October 6, 2009
For Release: Immediately
Contact: FDA Press Office
(301) 796-4649
Headline: FDA Marks 100th HIV/AIDS Drug Authorized for Purchase Under PEPFAR
The U.S. Department of Health and Human Services (HHS) today marked
today marked the recent approval of the 100th antiretroviral drug in
association with the President's Emergency Plan for AIDS Relief
(PEPFAR), aimed at the prevention, treatment, and care of people
infected with and affected by HIV/AIDS worldwide.
The PEPFAR program is a cooperative effort that involves the Food and
Drug Administration (FDA) and other HHS agencies, the State Department's
Office of the U.S. Global AIDS Coordinator, U.S. Department of Defense,
other federal agencies, host country governments, and many other
international partners.
"This milestone exemplifies the dedication, caring, and hard work of all
who strive to better the lives of those infected with or affected by
HIV/AIDS," said HHS Secretary Kathleen Sebelius.
To date, more than 100 products have been assessed by the FDA and either
fully or tentatively approved in association with the PEPFAR program. Of
these, 29 have been new products and 71 have been generic copies of
previously authorized antiretroviral products in the United States.
Twenty-two of these new products are new combinations or regimens that
have not previously been authorized in the United States. In addition,
there are seven new pediatric products considered innovative for
patients in developing economies.
"As we recognize the 100th product authorized in this program, it is
estimated that FDA's actions are allowing PEPFAR to spend $150 million
more each year on patient access to care," FDA Commissioner Margaret A.
Hamburg, M.D., told those attending an event marking the approval at the
Pan American Health Organization (PAHO) headquarters in Washington, D.C.
"I look forward to developing and expanding FDA's international
collaborations."
As of Sept. 30, 2008, the most recent figure available, PEPFAR supported
life-saving antiretroviral treatment for more than 2.1 million men,
women, and children living with HIV/AIDS. In fiscal year 2008, PEPFAR
provided nearly $1.6 billion in support of treatment programs, including
antiretroviral drugs and services.
"PEPFAR is committed to supporting partner countries to build and
maintain sustainable procurement and supply chain systems," said U.S.
Global AIDS Coordinator Eric Goosby.
Drug products used in PEPFAR receive a "tentative approval" and cannot
be approved for marketing in the United States because of existing
patents and marketing exclusivity. However, these products meet all the
FDA's manufacturing quality, clinical safety, and efficacy requirements
to produce them using the same standards as required for marketing in
this country.
FDA performs all of its reviews of applications received in association
with the PEPFAR on an expedited basis. After receiving approval or
tentative approval from FDA under this expedited process, a generic
anti-retroviral passes quickly on to the pre-qualification list
maintained by the Secretariat of the World Health Organization (WHO),
because of a confidentiality agreement that allows FDA to share data
from its evaluations with the WHO team in Geneva.
"Improving access to good quality medicinal products is a core objective
of public health efforts and one with a direct and measurable impact on
health," said Margaret Chan, M.D., director-general of WHO.
The goal of PEPFAR is to work with host nations to support treatment of
at least 3 million people, prevention of 12 million new infections, and
providing care for more than 12 million HIV-infected and affected people
by 2013. In addition, PEPFAR will support training of at least 140,000
health care workers in HIV/AIDS prevention, treatment, and care.
"We need to urgently and actively implement strategies to promote
greater affordability of both first and second line HIV/AIDS
antiretrovirals," said Mirta Roses, M.D., director of PAHO, an
international public health agency that works to improve health and
living standards in the Americas. "PEPFAR has made a tremendous
difference in the health of disadvantaged people."
For more information
PEPFAR Web site
http://www.pepfar.gov Improving Access to HIV/AIDS Drugs Abroad
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048558.htm ###
Note: All HHS press releases, fact sheets and other press materials are available at
http://www.hhs.gov/news-----------------------------------------------------------
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