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Accutane: Has Drug Regulation In The United States Reached Its Limits, Joan H. Krause
Accutane: Has Drug Regulation In The United States Reached Its Limits, Joan H. Krause
Journal of Law and Health
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 …
Prescription Drugs And The Duty To Warn: An Argument For Patient Package Inserts, Alan R. Styles
Prescription Drugs And The Duty To Warn: An Argument For Patient Package Inserts, Alan R. Styles
Cleveland State Law Review
It has been more than ten years since the Food and Drug Administration proposed regulations which would have required detailed patient information for all prescription drugs. The proposed regulations, intended to promote the safe and effective use of prescription drugs, would have required a manufacturer to supply non-technical, non-promotional information, referred to as patient package inserts, directly to the patient. This note will analyze the need for patient information in satisfying the tort objectives of informed consent and public safety. The note will then analyze the practical effect of the learned intermediary and informed consent doctrines upon the manufacturer's and …