Health Affairs, 27, no. 6 (2008): 1599 doi: 10.1377/hlthaff.27.6.1599 © 2008 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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Genomics

PROLOGUE

Genomics

A fundamental question for stakeholders—researchers, policymakers, and consumers alike—is whether these genomic discoveries are useful and can be translated into actual health care interventions that can practically and cost-effectively find their way into hospitals and doctors’ offices.

But how much evidence should be required to show that a discovery in the laboratory can or should move on to the marketplace? Genomic medicine clearly has created critical new challenges for the nation’s regulators in charge of making such determinations. They must set evidentiary standards high enough to select the truly efficacious products, but low enough to preserve incentives for future discoveries.

Discussion of appropriate information thresholds also prompts questions of whether adequate data sources exist to inform the decision-making calculus in the first place. The consequences of an unproven genomic technology sneaking past regulators into the marketplace not only could prove disastrous to the health of unwitting consumers, but also carries with it the potential to unnecessarily squeeze an already burdened health care system. Multiply this unfortunate outcome by the pace of genomic discovery, and the societal cost of "getting it wrong" fast becomes apparent.

The paper that follows offers decisionmakers guidance on how to approach such key questions. Muin Khoury and colleagues assert that the vetting process for genomic discoveries should be held to the same evidentiary standard of review as other scientific fields; they argue in favor of a "balanced and realistic approach to move such technology from research to practice." The accompanying Perspectives illuminate additional challenges confronting the "translational infrastructure" and offer innovative ideas for updating the regulatory system and navigating the journey from laboratory to marketplace.

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