A Guide to Fiscal Year 1991 Federal Funding for HIV Disease: How Dollars are Spent How to Access Them

for conducting AIDS-related product research and
review activities. Part of this effort involves in-depth
study related to cell biology, immunology and other
potential keys to understanding HIV and related
viruses at field laboratories. Vaccine-related research
is conducted in such areas as viral immunology,
pathogenesis, and molecular biology.
To enhance the expeditious development of drug
therapies and vaccines, the FDA advocates early consultation between scientists, reviewers, and drug and
vaccine sponsors, to provide technical assistance,
thorough understanding of regulations regarding
phased trials and protocols, and uniformity of understanding related to priorities in treatments and
therapies related to HIV disease and opportunistic
infections.
In addition, FDA monitors availability of nonapproved treatments and halt the marketing of
fraudulent health products. FDA education efforts
related to proper care and nutrition of those infected
with HIV involve publications, a nutrition videotape,
participation in conferences, and community-based
efforts.
Diagnostics
The FDA is responsible for approval of diagnostics
related to HIV disease. Specific and sensitive
diagnostic tools are vital to the safety of the blood
supply, as well as to the ability of physicians to properly diagnose and treat patients with HIV disease.
While responsible for approval of accurate and
effective diagnostic products, the FDA is also
involved in educating manufacturers to the key issues
related to manufacture and clinical evaluation of
diagnostics, participates with the American Red
Cross in screening programs to ensure safety of the
nation's blood supply, and has established guidelines
as to the type of diagnostics appropriate for use
related to HIV disease. For example, FDA policy has
established that home test kits for AIDS will not be
approved, while accurate rapid diagnostic screens for
HIV used in medical settings will be approved.

Medical Devices
FDA launched a program focused on preventing
transmission of HIV and AIDS-related diseases
through such barrier products as condoms, surgical
gloves, and commonly-used clinical devices.
The FDA conducts research on effectiveness of
condoms in preventing HIV transmission, as well as
studies on environmental factors related to improving effectiveness. FDA inspects manufactured products regularly to ensure compliance with its criteria
for acceptability. The FDA published a brochure promoting condom use in respect to HIV disease.
In the same way, FDA regulates manufacturing
practices related to production of latex and vinyl
gloves. Along with regular compliance inspections,
FDA is conducting research related to development
of more effective barrier protection.
Sterilization and disinfection practices related to
medical devices used in the health-care environment
is also under study. FDA is exploring ways manufacturers' products can be more easily sterilized, as well
as ways to improve sterilization and disinfecting
procedures.
No FDA HIV funds are available for competitive
applications. From time to time the FDA does issue
contracts for specific services, however they are not
normally handled through a competitive process.
For further information related to FDA HIVrelated programs and activities contact:
Randolph F. Wycoff, M.D. M.P.H.
Director
AIDS Coordination Staff
FDA
Parklawn Bldg, Rm. 12A-40
Rockville, MD 20857
301/443-0104

SGENCY FOR HEALTH CARE POLICY RESEARCH

The Agency for Health Care Policy Research
(AHCPR), formerly the National Center for Health
Care Services Research and Health Care Technology
Assessment (NCHSR), has a broad legislative mandate to support general health services research on

problems related to the organization, financing,
quality, and delivery of health services. AHCPR's
goal is to enhance the quality, appropriateness, and
effectiveness of health care services, and access to
such services through the establishment of a broad

72

Reproduction By Permission Only

~1991 ASAP

72 Reproduction By Permission Only ~1991 ASAP