Food and Drug Administration responses to the challenges of AIDS

Rarely has a public health issue emerged that has had impact on so many aspects of the responsibilities of the Food and Drug Administration. In a curious sense, the emergence of AIDS as a national problem has been timely. Only a few years ago, the scientific basis did not exist for performing studies of the immunology and pathogenesis of the syndrome--studies that should be helpful in directing therapeutic and preventive measures. Many of the techniques for studying AIDS and for manufacturing products to treat it involve modern technology. Research and policy actions that FDA has initiated have been designed to ensure as fully as possible the safety and effectiveness of regulated products that are relevant to AIDS and to apply new technology to this important public health problem.