AIDS HOME TEST KITS

Abstract

Given the emphasis on private, confidential and voluntary testing, the idea of an AIDS home test kit was inevitable. What could be more private, confidential and voluntary (and profitable) than buying a test kit at a drug store to take home and use? in 1986 the Food and Drug Administration (FDA) began receiving applications for various kinds of AIDS home test kits and immediately found itself at the center of a political maelstrom. Congressional subcommittees, AIDS activists, the gay community, doctors and scientists were quickly pitted against several entrepreneurs interested in bringing these products to market. FDA responded by refusing to even consider and evaluate any applications for AIDS home test kits for several years. Finally, in 1990 the FDA effectively reversed this policy and with little controversy began accepting applications for the kits. In this paper I want to assess the FDA's and the public's evolving response to the idea of AIDS home tests. Additionally, what is the FDA's role in a public health crisis such as the AIDS epidemic? What are legitimate criteria for FDA to weigh when evaluating a product such as an AIDS home test kit? More generally, are AIDS home test kits good public policy? I begin by sketching a brief history of the FDA's regulation of the product. Next I discuss the various arguments for and against an AIDS home test. I conclude with an analysis of the FDA's role in a debate such as this and some thoughts on the politics of AIDS.