Babies, Blemishes and FDA: A History of Accutane Regulation in the United States

Abstract

This paper takes a journalistic approach, tracing the chronology of Accutane in the U.S. in order to fill in the gaps of the story that has inspired so much controversy. Accutane has repeatedly pushed the frontier of FDA regulation, as the agency struggled to adapt its tools to meet the challenge of an extremely effective and extremely dangerous medication. By emphasizing the evolving American response to the high level of risk associated with Accutane, I hope to provide the material needed to evaluate the strengths and weaknesses of our current regulatory framework.