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Abstract

To assess the impact of the March 2009 decision in Wyeth v. Levine, it is crucial to understand that the Supreme Court ruled on actions that the U.S. Food and Drug Administration (FDA) took under a statutory scheme that already had been amended by the time the case was decided. The Food and Drug Administration Amendments Act of 2007 (FDAAA) transformed drug regulation, adding significant new powers to develop evidence and make new types of decisions in the postmarket period. This article explores how the contours of drug regulation are likely to change after FDAAA, which is the most profound reworking of the U.S. drug regulatory framework in half a century. FDAAA envisions heavy use, during the period after drugs are approved, of evidence from large observational studies that rely on interoperable health data networks. Understanding what was wrong with FDA's old evidentiary paradigm, which dates back to 1962, is essential to understanding its new one. Parts II and III of this article discuss the evidentiary limitations of premarket drug trials;important aspects of modern legal doctrine rest on misconceptions about their evidentiary power. Part IV then explores how scientific advances flowing from the Human Genome Project over the past decade further undermined FDA's old evidentiary paradigm. FDAAA was Congress's response to these problems. Part V identifies seven pillars of the new evidentiary paradigm: seven novel propositions that reject foundational assumptions of twentieth-century drug regulation. Collapse of these assumptions sets off ripple effects in various doctrinal areas. Part VI provides two examples, with the aim of opening a scholarly debate about these and other impacts of FDA's new evidentiary paradigm.

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