Alan R. Styles


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 physician's duty to supply patient information. The note will then analyze the FDA regulations leading to the proposed patient package insert (PPI) program, the program itself, the rationale for the program and the reasons for its revocation. Finally, the note will present rationale for re-enacting the FDA regulations.