Health Affairs, 25, no. 4 (2006): 1095-1102 doi: 10.1377/hlthaff.25.4.1095 © 2006 by Project HOPE	New Online   How Would Obama, McCain Cover The Uninsured?   Debating Cost Of Uninsured   Try Medicare-For-All   HA Blog Top 10

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The Rise And Fall Of Natrecor For Congestive Heart Failure: Implications For Drug Policy

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

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