Predicting the Genetic Makeup of FDA

Abstract

Genetic testing holds promise as the either the most beneficial or the most destructive creation of the new millennium. The consequences of genetic testing research are far-reaching, with the potential for finding cures to diseases such as cancer, or destroying an individual's life by changing insurance ratings, employment opportunities, and reproductive decisions. The scientific, legal, socioeconomic, and ethical implications of genetic testing demand appropriate regulatory controls. The responsibility of regulation falls on various governmental agencies, including the Food and Drug Administration (FDA). However, the neophyte genetics industry, ever evolving through biotechnological developments, does not have sufficient safeguards to meet the challenges posed by the impending completion of the Human Genome Project. Whether FDA is the appropriate regulatory body to solve these imminent problems is a question requiring a detailed exploration of genetic testing, the Human Genome Project, FDA's history, current regulation of genetic testing, critiques of FDA involvement, and alternative solutions.