ACCUTANE: POST-APPROVAL DRUG REGULATION IN A RISK MANAGEMENT FRAMEWORK

Abstract

The acne drug Accutane lies at the center of a movement to expand post-approval controls on drug regulation in an effort to effectively manage drug risks. Accutane’s regulatory history tracks a trend towards the increasing emphasis in drug regulatory policy on post-marketing risk management. The Accutane experience illustrates the fundamental regulatory problems of drug safety, drug availability and individual autonomy driving this shift. Recent reform of Accutane regulation through the S.M.A.R.T. program both exemplifies the trend and suggests its limitations.