[Ip-health] IDSA and HIVMA on call on Bush to permit purchase of generic FDCs

[Asia Russell]

PRESS RELEASE
For Immediate Release: April 15, 2004

Contact: Sarah Danberg, sdanberg@idsociety.org
(703) 299-0878

President's Plan Would Limit Access
To Effective, Low-Cost Generic AIDS Drugs in Developing Countries

The HIV Medicine Association (HIVMA) and the Infectious Diseases Society of
America (IDSA) are urging the Bush administration to adopt the World Health
Organization=92s (WHO) quality standards for purchasing HIV/AIDS drugs inst=
ead
of developing its own process that will take up precious time while lives
are at stake.

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 1=
4
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 antiretrovira=
l
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PEPFAR resources are withdrawn.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=92s president. "These standards have long been u=
sed
by the United States in the context of medications and vaccines for other
infectious diseases."

HIVMA and IDSA applaud the president=92s 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=92s plan should be u=
sed
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=92s homepage at http://www.hivma.org
<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.