America Living With AIDS

program. The Commission was particularly concerned about the underrepresentation of people of color and
women in HIV-related clinical trials.
The Commission is pleased to note
that NIH has increased the participation of people of color and women in
their ACTG trials, and strongly recommends that these current efforts be
continued and increased.
NIAID also sponsors the Community Programs for Clinical Research on
AIDS (CPCRA). These programs are
designed to encourage the participation of persons currently underrepresented in the ACTG Program in welldesigned trials. It is important to note
that this program should serve as an
additional research opportunity for
underrepresented communities and
not as a substitute for their participation in ACTG trials. The program is
also designed to utilize the considerable expertise and energy of community-based physicians and organizations for the conduct of sound
research. The Commission continues
to consider this to be an imaginative
and effective program that should be
continued and expanded in parallel
with steps necessary to strengthen the
ACTG Program. The Commission
also strongly supports CPCRA's
emphasis on the prevention and treatment of opportunistic infections as
the highest scientific priority of the
program.
The appropriate balance between
research on antiviral drugs (aimed at
HIV, the underlying cause of AIDS)
and drugs targeted for treatment and

prevention of the many opportunistic
infections associated with HIV disease
has also been a topic of much discussion and concern for many people
with HIV disease, for members of the
research community, and for the
National Commission on AIDS. The
Commission continues to believe that
both areas of research are vitally needed and that the dollars to ensure both
are essential. Congress should provide
sufficient funding to enable NIH to
give greater priority to research related
to opportunistic infections without
undermining research on antiviral
drugs.
Sufficient funding is essential for all
HIV-related research activities to protect against shifting funds from one
vital area of research to pay for another. The development of an NIH plan,
as recommended by the Institute of
Medicine in its study of the AIDS
Research Program of NIH, would go a
long way toward helping to identify
and plan for HIV-related research priorities and funding needs.
DRUG DEVELOPMENT
AND APPROVAL
The Food and Drug Administration
(FDA) is the federal government agency with the responsibility to ensure
that drugs meet standards of safety
and efficacy before they are marketed.
FDA does not initiate drug development, but rather its regulatory decisions can determine which drugs
(developed by the pharmaceutical
industry, or the government, or both)
reach the marketplace.
During much of the HIV epidemic
FDA has been criticized for not acting