Joan H. Krause


By a careful examination of the Accutane experience, both here and abroad, I will illustrate some of the shortcomings of the current American system of drug regulation. There are a number of ways in which this system fails to live up to the strict regulatory philosophy that it purports to follow; in particular, there are systematic inadequacies in the design of clinical trials, the official labeling received by drugs, and the manner in which adverse reaction reports are collected and assessed. Additionally, although the system often works well, there are natural limitations to a system of pre-approval testing; for some drugs, such as Accutane, it is foreseeable that the current U.S. approach will not provide an adequate degree of patient safety. It is my position that we must both improve current regulatory safeguards to meet the stringent standards we have set up, and also be willing to implement stricter post-approval controls for the few distinct cases where pre-approval safety in the relevant patient populations cannot be adequately assured. Part II of this paper will provide background information on the history and procedures of the FDA and the drug Accutane. Part III will analyze the regulatory problems of our current system, as illustrated by our experience with Accutane. Part IV will explore an alternative method of regulation, illustrated by that used in England.