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FDA
Human Immunodeficiency Virus and
Acquired Immunodeficiency Syndrome
current August 2006
The Food and Drug Administration (FDA), is a regulatory agency that enforces the Food, Drug, and Cosmetic Act and the Public Health Service Act, assuring that drugs and biologics are safe and effective for their intended uses, and properly labeled. FDA's activities help protect all consumers in the United States, regulating some trillion dollars worth of products that constitute approximately one-fourth of total consumer expenditures in the United States. FDA sets standards for, and monitors all prescription and non-prescription drugs; all blood products, vaccines, and tissues for transplantation; all medical devices and equipment, and all radiation emitting devices; all animal drugs and feed; nearly all domestic and imported foods except for meat and poultry; and all cosmetics.
FDA responsibilities include a variety of HIV/AIDS-related issues. The agency primarily serves a review and oversight function in areas related to drugs, biologics and medical devices for the prevention and treatment of HIV/AIDS, and AIDS-related conditions.
Among the regulatory activities related to regulation of therapeutic products, FDA:
More Information: HIV/AIDS Therapeutics
There are a number of areas where the FDA impacts upon prevention of the transmission of HIV. These include:
FDA assures that diagnostic and blood screening assays for HIV are sensitive
and specific for the detection and/or quantification of HIV in blood and other
body fluids, including urine and oral fluid. Diagnostic tests, such
as enzyme immunoassay (EIA) and Western Blot antibody tests, are used to diagnose
HIV exposure or infection in individuals. Patient monitoring tests, such
as polymerase chain reaction (PCR) viral load and genotyping tests are used
for prognosis and therapeutic management. Blood screening tests, including
EIA, nucleic acid and PCR tests, are used detect blood collected from infected
individuals, and prevent it from entering the blood supply.
More Information: Licensed /
approved HIV, HTLV and hepatitis tests
FDA monitors food under its jurisdiction to ensure it is not adulterated or contaminated with pathogens. The agency also has an educational program about shellfish safety for immunocompromised people, including these publications:
FDA also conducts regulatory research to establish product standards and develop improved testing methods to assess the safety of drugs and biologics. FDA's broad based, multi-disciplinary research programs have played a significant rule in the development of vaccines, therapeutic agents, and test kits for use in AIDS and AIDS-related conditions. This research includes work on HIV infection and vaccine models for its prevention, and studies of the immune response to HIV.