The Approval of Over-the-Counter HIV Tests: Playing Fair When Making the Rules

Abstract

This paper looks at some of the ethical concerns regarding a recent application to the U.S. Food and Drug Administration (FDA) for approval of the sale of HIV tests over-the-counter (OTC) directly to consumers. The concept of at-home HIV testing is not new, but OraSure Technologies Inc., a U.S. manufacturer of rapid HIV tests, is now seeking FDA approval to take at-home testing one step further to enable consumers to test themselves and interpret the results without the assistance of an outside party. This paper reviews some of the purported benefits and potential risks of at-home HIV testing, and looks at the way one Canadian company is attempting to address the potential risks. In doing so, this paper brings to the fore concerns regarding corporate involvement in the regulatory approval of biotech products.