Health Affairs, 26, no. 3 (2007): 684-695 doi: 10.1377/hlthaff.26.3.684 © 2007 by Project HOPE	New Online   Senate Health Reform Bill   Rewarding Providers   Public Option Policy Brief   Health Reform & Abortion   Delivery System Reform

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Tools & Incentives

Assessing A Structured, Quantitative Health Outcomes Approach To Drug Risk-Benefit Analysis

Regulatory authorities make difficult risk-benefit decisions when approving new drugs. Food and Drug Administration (FDA) advisory committees and reviewers must consider a complex body of evidence, including efficacy and safety results of trials, disease epidemiology, potential side effects, and patients’ needs. However, this menu of information is not usually presented in a consistent and integrated framework. The members of an FDA review panel vote with some unobserved, implicit weighting of the evidence. This paper argues that outcomes research tools for modeling long-term health outcomes, measuring health preferences, and establishing the value of additional information could provide a more structured, transparent, and quantitative process of assessing risk-benefit balance.

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