Access to Safety Data — Stockholders versus Prescribers

Abstract

A reprint of the article "Access to Safety Data Stockholders Versus Prescribers," by Marc A. Pfeffer and Marianne B. Bowler which was published at NEJM.org on June 29, 2011 is presented. The article focuses on drug safety data. It notes that both the legal and the medical system require evidence for use as basis for decision making in which the latter uses clinical trials. It is said that information on drug safety need not have the same level of certainty required when demonstrating efficacy.