HIV (Human Immunodeficiency Virus)
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FDA's Role in HIV
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, and AIDS-related conditions.
There are a number of areas where the FDA impacts upon prevention of the transmission of HIV. These include:
Helping to ensure the safety of the nation’s blood supply.
Surveillance and quality assurance of barrier products, including condoms, the female condom, dental dams, surgical and medical gloves, etc.
Working with industry and government developers of both preventive and therapeutic vaccines for HIV.
Working with sponsors, NIH, and other researchers to develop practical topical microbicides to prevent the spread of HIV by creating a chemical barrier to transmission of live virus.
Ensuring proper device sterilization and disinfection in reprocessing of medical devices between patients by health care facilities to prevent transmission of HIV/AIDS.
More information: Prevention
Diagnostic Testing and Blood Screening
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.
FDA monitors food under its jurisdiction to ensure it is not adulterated or contaminated with pathogens.
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 role 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, as well as conducting, planning, or consulting on epidemiology studies of the role devices or radiation play in the transmission, prevention, detection, or treatment of HIV infection and closely associated conditions.
Inspection of clinical trial sites and study records
Audit of Institutional Review Boards (IRB)
Inspection of medical product manufacturing facilities
Blood bank establishment inspections
Improving Access to HIV/AIDS Drugs Abroad
To support the President's Emergency Program for AIDS Relief (PEPFAR), FDA developed special expedited review procedures that allow FDA to quickly review applications for generic formulations or fixed-dose combinations of approved drugs.FDA's assessment process helps make the drugs available in developing countries, but protects the property rights of drug companies in the United States.