The Rise and Fall of Natrecor for Congestive Heart Failure: Implications for Drug Policy

Abstract:     
Recent revelations of unexpected side effects of widely prescribed medications have raised questions about several aspects of U.S. drug policy, from initial FDA approval to promotion by manufacturers and subsequent prescribing by physicians. One prominent example is nesiritide (Natrecor), a new treatment for congestive heart failure. We use nesiritide as a case study to assess how FDA standards for drug approval, marketing practices by drug manufacturers, and physician prescribing choices can shape the risk-benefit relationship of new drugs. Based on the nesiritide experience, we suggest several policy changes to improve policies for drug approval, post-marketing surveillance process, and drug utilization.

Keywords: FDA, Drug policy, Post-marketing surveillance

Accepted Paper Series